The U.S. Food and Drug Administration (FDA) has approved Tasigna (nilotinib) capsules for treatment of Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients whose disease has progressed on or who cannot tolerate other therapies that included imatinib. Imatinib (Gleevec) is approved for the treatment of new diagnosed patients with Philadelphia chromosomepositive CML.
FDA's approval of Tasigna includes a black box warning for possible life-threatening heart problems that may lead to an irregular heartbeat and possible sudden death.
CML accounts for 15 percent of all leukemias in adults. Approximately 4,500 new cases of CML will be diagnosed in 2007. An abnormal chromosome, called the Philadelphia chromosome, is located in the leukemic cells and is present in the majority of CML patients.
"This represents another treatment option for CML patients who are resistant to or can no longer tolerate imatinib," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research. "Patients should consult with their physicians, however, because of possible life-threatening heart problems associated with this drug."
The effectiveness of Tasigna is based on response rates observed in an ongoing clinical trial. Responses are associated with normalization of blood counts and bone marrow examinations. Further follow-up of patients is needed to determine how long these responses will last.
Patients may lower their chances for the heart problems by taking Tasigna without food, and by avoiding grapefruit products. Patients should also consult with their physician or other health care professional about avoiding other medications that can cause heart problems when taking Tasigna.
Patients with low blood potassium or magnesium should not use Tasigna.
The most common side effects include low blood counts, rash, headache, nausea and itching. Other possible serious side effects include liver damage, fluid accumulation and pancreas inflammation.
Women are advised to avoid becoming pregnant while taking Tasigna. Women who become pregnant are advised that Tasigna can harm their unborn child. Nursing mothers are advised not to breastfeed their child while taking the drug.
Tasigna is manufactured by Novartis Pharmaceuticals Corporation, East Hanover, N.J.
Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Aprotinin Injection (marketed as Trasylol), a drug used to control bleeding during heart surgery.
Last week, FDA was notified that a Canadian research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to the other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The data also suggested that fewer patients receiving the drug experienced serious bleeding events.
This most recent data support the results from other comparison studies of Trasylol. The comparison studies were discussed at a September 2007 joint meeting of FDA's Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees, which represent one part of FDA's oversight and review of drugs throughout their life cycles.
FDA anticipates further review of the risk and benefits of Trasylol, which may result in additional labeling or other regulatory action. FDA will work with the sponsor of the recently terminated study to evaluate the data fully.
In the meantime, FDA recommends that health care providers review the risks and benefits of Trasylol outlined in the label and in the Early Communication about an Ongoing Safety Review, and discuss the information with their patients.
In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.
Trasylol is marketed by Bayer Pharmaceuticals Corp., Leverkusen, Germany.
This early communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews. Full text of the Early Communication about an Ongoing Safety Review can be found at http://www.fda.gov/cder/drug/early_comm/aprotinin.htm.
The U.S. Food and Drug Administration today approved a change in the storage conditions for Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand Disease (vWD).
The treatment, a protein that helps blood form the clots necessary to stop bleeding, can now be safely stored for up to two years at 77 degrees Fahrenheit. Previously, Humate-P required colder, refrigerator-level temperatures for that storage length.
Approval of this change was based on stability data submitted by the company including laboratory tests of product potency conducted under different temperatures.
“The change in storage conditions will help patients, their families and treating physicians better manage the product, especially as part of medically supervised home treatment programs,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research.
Humate-P is approved for the treatment and prevention of bleeding in adult patients with hemophilia A, a rare clotting disorder. It is also approved for the treatment of spontaneous and trauma-induced bleeding and the prevention of excessive bleeding related to surgery in adult and pediatric patients with vWD, the most common inherited bleeding disorder in the United States.
Humate-P is manufactured from human plasma obtained from screened and tested U.S. donors.
Reported adverse reactions include allergic reactions such as hives, rash, chest tightness, swelling, and shock. Blood clots have been observed in patients under treatment for vWD.
Humate-P was first approved in 1986 for the treatment and prevention of bleeding in patients with hemophilia A. It was first approved for use in patients with vWD in 1999.
The product is manufactured by CSL Behring GmbH in Marburg, Germany.
The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.
In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.
The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.
“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.
Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.
A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 postmarketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.
Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.
Product Web sites, marketing and educational materials, and advertisements for PDE5 inhibitors will reflect the revised product labeling. The label revisions can be viewed at: www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm.
For more information:
http://www.fda.gov/cder/drug/infopage/ed_drugs/QA.htm
The U.S. Food and Drug Administration today expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10 years.
Meningitis is a serious inflammation of the lining that surrounds the spinal cord and brain. It can result in death or permanent injury to the brain and nervous system. In the United States, about 2,600 people become ill from bacterial meningitis annually. About 10 percent die from the infection and another 15 percent or so suffer brain damage or limb amputation.
Menactra was first approved by FDA in January 2005 for people ages 11 to 55 years. Previously, Menomune was the only meningococcal vaccine available in the United States for use in children, ages 2 years and older. Both products are manufactured by sanofi pasteur Inc. of Swiftwater, Pa. Both vaccines offer protection against four groups of Neisseria meningitidis, the bacterium that can cause meningitis.
“Approving Menactra for younger children offers another option for health care providers and parents. Now there are two vaccines available for children between 2 and 10 years of age who may be at increased risk of meningitis,” said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) currently recommends meningococcal vaccination for children ages 2 to 10 years who are at increased risk of developing meningococcal disease, such as those who have had their spleen removed or whose spleen is not functioning; those with a medical condition called terminal complement component deficiency which makes it difficult to fight infection; and those who expect to travel to areas outside of the United States where the disease is common. Vaccination also is used to control outbreaks of bacterial meningitis.
Menactra’s effectiveness was measured in clinical trials that included people ages 2 to 55 years. The vaccine was shown to produce an immune response one month after vaccination. The safety of Menactra was evaluated in eight clinical studies that included a total of 10,057 participants who received Menactra and 5,266 participants who received Menomune. The most common adverse events reported in the studies were pain at the injection site and irritability. Diarrhea, drowsiness, and lack of appetite also were common.
While not observed in these clinical trials, Guillain-Barré syndrome (GBS), a neurological disorder that causes muscle weakness, was noted as a possible but unproven risk in some adolescents following immunization with Menactra, occurring in an estimated 1 in 1 million vaccine recipients. As a precaution, people who have previously been diagnosed with GBS should not receive Menactra.
FDA and CDC will continue to monitor the safety of Menactra through their jointly administered Vaccine Adverse Event Reporting System.
The U.S. Food and Drug Administration has approved doripenem injection, 500 mg intravenous infusion, for the treatment of complicated urinary tract and intra-abdominal infections. Doripenem injection, sold under the trade name Doribax, has been shown to be active against several strains of bacteria.
“This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.
In several multi-center, multinational studies, doripenem was shown to have a cure rate comparable to the currently prescribed medications levofloxacin, for complicated urinary tract infections, and meropenem, for complicated intra-abdominal infections.
The most common adverse reactions reported were headache, nausea, diarrhea, rash, and phlebitis. In addition, allergic reactions have occurred and some may require immediate treatment.
The safety and effectiveness of doripenem injection in pediatric patients have not been established. Doripenem has not been studied in pregnant women, and the drug should be used during pregnancy only if clearly needed.
Doripenem injection is manufactured by Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, N.J.
The U.S. Food and Drug Administration (FDA) has approved raltegravir tablets for treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
Raltegravir is the first agent of the pharmacological class known as HIV integrase strand transfer inhibitors, designed to interfere with the enzyme that HIV-1 needs to multiply. Raltegravir, sold under the trade name Isentress, received a priority review by the FDA.
“This is an important new product for many HIV-infected patients whose infections are not being controlled by currently available medications,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.
When used with other anti-HIV medicines, raltegravir may reduce the amount of HIV in the blood and may increase white blood cells, called CD4+ (T) cells, that help fight off other infections.
FDA’s approval of raltegravir is based on data from two double-blind, placebo-controlled studies in 699 HIV-1 infected adult patients with histories of extensive antiretroviral use. A greater proportion of the patients who received raltegravir in combination with other anti-HIV drugs experienced reductions in the amount of HIV in the blood, compared with patients who received placebo in combination with other anti-HIV drugs.
The most common adverse events reported with raltegravir were diarrhea, nausea, and headache. Blood tests also showed abnormal elevated levels of a muscle enzyme in some patients receiving raltegravir. Caution is advised when using raltegravir in patients at increased risk for certain types of muscle problems, including those who use other medications that can cause muscle problems.
Patients taking raltegravir may still develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV-1 infection. The long-term effects of raltegravir are not known, and its safety and effectiveness in children less than 16 years of age has not been studied.
Raltegravir also has not been studied in pregnant women. Women who are taking HIV medications when they get pregnant are advised to talk with their physician or other health care professional about use of this drug during pregnancy, and about registering with the Antiviral Pregnancy Registry if they use raltegravir.
Raltegravir is distributed by New Jersey-based Merck & Co., Inc.
Gerald F. Masoudi has been appointed as associate general counsel/chief counsel of the Food and Drug Division of the United States Department of Health and Human Services' Office of the General Counsel, which handles legal matters for the U.S. Food and Drug Administration.
Since 2005, Masoudi has been deputy assistant attorney general in charge of International, Policy and Appellate Matters in the Antitrust Division at the U.S. Department of Justice. From 2004-2005, he served as principal deputy associate general counsel for the Food and Drug Division, serving for a time as acting associate general counsel. Before joining the Food and Drug Division, Masoudi was a partner at Kirkland & Ellis LLP.
"We are pleased to have Jerry's expertise and insight back at HHS," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "His leadership and service will be critical to FDA's public health mission and regulatory responsibilities."
Masoudi earned his bachelor's degree from Amherst College in 1990. He graduated with high honors from the University of Chicago Law School in 1993, where he was an editor of the Law Review. He also clerked for Judge Frank H. Easterbrook of the U.S. Court of Appeals for the Seventh Circuit.
Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health:
Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.
These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.
Defibrillators are life-saving products for patients with a heart rhythm abnormality. We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect. However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.
Today, Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.
Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today's action.
Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.
When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don't know if this rate of adverse events will remain constant or increase over the life of these leads.
FDA considers Medtronic's action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. We recognize that some patients and health care professionals might inappropriately interpret the word "recall" to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.
The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic's recommendation that defibrillator settings be adjusted at the patient's next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed.
Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.
Patients should recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.
FDA will continue to monitor information on these devices and will take whatever other actions may be necessary.
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized on Tuesday approximately $71,000 of goods from FulLife Natural Options, Inc., of Boca Raton, Fla., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.
Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension. These claims are evident in the products' labeling, including promotional literature and FulLife's Internet Web site.
The agency takes seriously its responsibility to protect Americans from unapproved drugs. FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products' labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. Tuesday's action protects consumers who may rely on unapproved products and unsubstantiated claims associated with these products when making important decisions about their health.
The Complaint, filed by the U.S. Attorney's Office for the Southern District of Florida, charges the products are in violation of the drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.
Following an investigation of the firm's marketing practices, FDA officials advised FulLife that the claims related to prevention or treatment of diseases made these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to bring its marketing into compliance with the law. During subsequent inspections, FDA inspectors found that the offending claims were still being made.
The seizure Tuesday at FulLife is the second such enforcement action in two months taken by FDA against dietary supplements being promoted with drug claims to cure or treat diabetes and other diseases or conditions.
On August 23, 2007, at the request of FDA, U.S. Marshals in the Northern District of Florida seized an estimated $41,000 worth of inventory of Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex, MSM-1000, and Atri-E-400 capsules being promoted and distributed by Charron Nutrition of Tallahassee, Fla., for use in treating diabetes, arthritis, and other serious health conditions.
The U.S. Food and Drug Administration today approved the first generic versions of Trileptal (oxcarbazepine), an anticonvulsant drug. Generic oxcarbazepine is FDA-approved for use alone or in combination with other medications in the treatment of partial seizures in adults and children aged four years and above.
"FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs," said Gary J. Buehler, director of FDA's Office of Generic Drugs. "The agency ensures that generic drugs are safe and effective, offering alternatives to Americans in choosing their prescription drugs."
Oxcarbazepine tablets in three strengths (150 milligrams, 300 milligrams and 600 milligrams) are manufactured by Roxane Laboratories Inc., Glenmark Pharmaceuticals Limited, and Sun Pharmaceutical Industries Limited.
The labeling of the generic products may differ from that of Trileptal because parts of the Trileptal labeling are protected by patents and/or exclusivity.
According to the publication Drug Topics, Trileptal was 74th best selling brand-name drug in by retail dollars in the United States in 2006.
Serious skin reactions have been reported in children and adults in association with Trileptal use. In the event a skin reaction should occur while taking Trileptal patients should immediately consult with their health care provider. Common side effects reported with Trileptal use include dizziness and drowsiness.
For information:
FDA Generic Initiative for Value and Efficiency
www.fda.gov/oc/initiatives/advance/generics.html
FDA's Office of Generic Drugs
www.fda.gov/cder/ogd/
Frequently asked questions about generic drugs
www.fda.gov/cder/consumerinfo/generics_q&a.htm
The U.S. Food and Drug Administration today announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.
The award to Oakland, Calif.-based CPD is part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.
“This transformative program will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting center director.
The IOM report, The Future of Drug Safety — Promoting and Protecting the Health of the Public, identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them. Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.
The CPD contract runs through Sept. 20, 2009.
For more information
The Future of Drug Safety — Promoting and Protecting the Health of the Public
FDA's Response to the Institute of Medicine's 2006 Report http://www.fda.gov/oc/reports/iom013007.html#intro
At the request of the U.S. Food and Drug Administration, on Wednesday, U.S. Marshals seized more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human or animal use, dietary supplements, and ingredients to make those products because some lacked FDA approval and all were maintained under grossly unsanitary conditions by General Therapeutics Corp., of St. Louis, Mo.
The FDA considers NC Solution to be a drug because it is intended for the use in the diagnosis, cure, or treatment of disease in people or animals. NC Solution is also a new drug because it is not generally recognized as safe and effective for its intended uses.
Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by the FDA. The company does not have approval for NC Solution.
“The action taken Wednesday is the culmination of the concerted efforts by the FDA to get the firm to follow the law when it comes to manufacturing safe products for consumers,” said Margaret O'K. Glavin, FDA Associate Commissioner for Regulatory Affairs.
In August and September, FDA inspectors found that the company was still manufacturing drugs and dietary supplements under unsanitary conditions, including insects and rodent filth on and around manufacturing equipment, despite a warning by FDA of serious violations in 1999. Following the 1999 inspection, a company official told the FDA in January, 2000, it would stop manufacturing drugs.
The FDA recommends that consumers who have any products manufactured by General Therapeutics, including NC Solution, consult their health care provider about discontinuing use and if they have experienced any adverse events that they suspect are related to the product's use.
Catherine L. Hanaway, U.S. Attorney for the Eastern District of Missouri, filed the complaint requesting the seizure, and her office will continue to coordinate with the FDA to ensure proper disposal of the seized items.
The FDA's action against the company is consistent with the agency's initiative on unapproved drugs which pose potentially harmful risks to consumers.
The U.S. Food and Drug Administration yesterday requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients. The products, often advertised as ``all natural'' alternatives to approved erectile dysfunction drugs, could interact with medications and cause dangerously low blood pressure. They contain substances that have similar structures to active ingredients in approved prescription drugs.
The FDA has not approved True Man or Energy Max, and their safety and effectiveness are unknown.
The FDA requested the recall of all products distributed under both labels in a letter to Yin Kao, president and owner of America True Man Health Inc., of West Covina, Calif.
The products are often advertised in newspapers, retail stores, and on the Internet.
“The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer and acting director of the FDA’s Center for Drug Evaluation and Research.
As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil; or piperadino vardenafil, an analog of vardenafil. Analogs may cause side effects and drug interactions similar to the approved drugs they resemble.
The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
The FDA issued an alert on May 10, 2007, (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01633.html) advising consumers not to buy or use True Man or Energy Max products. Today’s recall request comes as a result of the company previously failing to notify all of their consignees and involves True Man Sexual Energy packaged in blister pack cartons of 10 capsules and Energy Max packaged in blister pack cartons of 20 capsules. FDA is prepared to take further regulatory action should the firm refuse to accede to this request.
FDA chemical analysis has shown that Energy Max contains thione, an analog of sildenafil, a substance similar to the active ingredient in the approved ED drug Viagra. In addition, FDA investigators found that True Man contains the same analog or an analog of vardenafil, the active ingredient Levitra, another approved ED treatment. Neither of the analogs used in True Man or Energy Max are components of FDA-approved drug products.
Customers who have either product in their possession should stop using it immediately and contact their health care provider if they have experienced any problems that may be related to taking this product.
Consumers should report adverse events related to these products to MedWatch, the FDA's voluntary reporting program:
www.fda.gov/medwatch/report.htm
800-332-1088
Fax: 800-332-0178
Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787
The U.S. Food and Drug Administration has selected 15 voting members to serve on its Risk Communication Advisory Committee. The Committee will advise FDA about how best to communicate to the public about the risks and benefits of FDA-regulated products so as to facilitate their optimal use.
On June 5, 2007 FDA announced the establishment of the advisory committee and requested nominations for qualified individuals to serve as members. The agency received more than 240 nominations, many for exceptionally qualified individuals.
The establishment of the advisory committee was one of the recommendations of the Institute of Medicine’s 2006 report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public."
"Communicating effectively about the safety and effectiveness of drugs and other medical products is one of the central roles of FDA," said Randall Lutter, Ph.D., Deputy Commissioner for Policy. "We were in such strong agreement about the value of the Risk Communication Advisory Committee that we expanded its scope to address communication regarding all products regulated by the agency, including our food supply responsibilities."
The advisory committee’s 15 voting members include independent experts and public members. Experts were chosen from the fields of risk communication, risk perception, decision analysis, communication, social marketing, health literacy, journalism, and other behavioral and social sciences. Public members include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health care providers. For some meetings, one or more industry representatives may be invited to participate in a nonvoting capacity.
Members have been assigned to serve for periods ranging from one to four years. FDA expects to hold the committee’s first meeting in the first quarter of 2008. The list of members is available on FDA’s Web site at http://www.fda.gov/oc/advisory/OCRCACRoster.htm.
FDA is currently amending the committee’s charter to incorporate the provisions of the recently passed Food and Drug Administration Amendments Act of 2007.
The U.S. Food and Drug Administration (FDA) today announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.
Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.
On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.
The U.S. Food and Drug Administration today announced that it has cleared for marketing a breathing tube coated with a thin layer of silver. The coating, a material known to have antimicrobial properties, reduces the risk that patients on ventilators will acquire pneumonia while in the hospital.
The Agento endotracheal tube, manufactured by C.R. Bard Inc., is intended for patients who must rely on a ventilator to breathe for 24 hours or more.
Patients requiring such a breathing support system are at risk of exposure to hospital-acquired bacteria that can build up on the breathing tube or pass through the tube to their lungs, eventually causing a lung infection known as ventilator-associated pneumonia (VAP).
Fifteen percent of the patients on ventilators develop VAP every year and 26,000 die from the infection, according to the Centers for Disease Control and Prevention.
"Patients who require ventilator support are at increased risk for pneumonia, which poses a significant public health issue. This product can help to lower this risk," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health.
Silver has been known for its antimicrobial properties for decades and has been used for this purpose on several types of devices. This is the first endotracheal tube coated with silver.
In a multicenter clinical trial comparing the Agento breathing tube to an uncoated tube, the percentage of patients who developed pneumonia was reduced from 7.5 percent to 4.8 percent. The Agento also delayed the onset of pneumonia.
The FDA in July issued a proposed guidance document on antimicrobial device submissions stating that when companies claim their product reduces or prevents device-related infections, the claim should be supported by such clinical data.
C.R. Bard is located in Murray Hill, N.J.
The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure.
The labeling changes, which incorporate advice from FDA advisory committees and expand upon labeling changes made in March 2007, also include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who are treated with ESAs.
Epogen, Procrit and Aranesp are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer. Epogen and Procrit are also approved for use in certain patients with anemia who are scheduled to undergo major surgery to reduce blood transfusions during or shortly after surgery and for the treatment of anemia caused by zidovudine (AZT) therapy in HIV patients.
For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater.
The boxed warnings also emphasize that no clinical data are available to determine whether there is a similar risk of shortened survival or increased tumor growth for patients with cancer who receive an ESA dose that attempts to achieve a hemoglobin level of less than 12 g/dL. This is the hemoglobin level commonly achieved in clinical practice.
Health care providers determine whether a patient is anemic and decide on ESA dosing by measuring how much of the protein known as hemoglobin is present in a patient's red blood cells.
An earlier boxed warning, approved in March, described the results of six studies demonstrating that survival was shorter and tumors progressed faster when ESAs were used to achieve hemoglobin levels of 12 g/dL or greater in cancer patients.
Today's new boxed warning also clarifies that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Moreover, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.
"Health care professionals need to consider the risks of increased tumor progression and decreased survival in patients with cancer when prescribing ESAs," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer and acting director of its Center for Drug Evaluation and Research. "ESAs should be used in patients with cancer only when their anemia is due to chemotherapy and only at the lowest dose necessary to avoid the need for blood transfusions."
The FDA is working with the manufacturer to design and conduct clinical trials of different dosing regimens and tumor types to further characterize potential tumor progression associated with ESAs.
For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and for serious cardiovascular reactions such as stroke, heart attack or heart failure, the boxed warning states.
In addition to the boxed warning, the new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.
The new labeling also emphasizes that there are no data from controlled trials demonstrating that ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being for patients with cancer or for patients with HIV undergoing AZT therapy.
In March 2007 the FDA approved labeling changes and issued a public health advisory outlining the new safety information about ESAs. Safety concerns regarding ESAs were discussed during May 2004 and May 2007 meetings of FDA's Oncologic Drug Advisory Committee and a September 2007 joint meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. ESA product labeling was previously revised in 1997, 2004 and 2005 to reflect new safety information.
The agency is currently reviewing a proposed Medication Guide that will better communicate the safety and effectiveness of ESAs to patients and will replace the existing patient labeling.
ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. These drugs are manufactured by Amgen Inc., Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J, a subsidiary of Johnson & Johnson.
For more information: http://www.fda.gov/cder/drug/infopage/RHE/default.htm
The Food and Drug Administration (FDA) has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, for nonprescription use in adults and children 12 years of age and older. This drug combines an antihistamine with a nasal decongestant.
Available as a prescription drug since 2001, Zyrtec-D is now approved as a nonprescription drug for the relief of symptoms due to hay fever or other upper respiratory allergies such as, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion. Zyrtec-D is also for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose.
Hay fever and other allergies are the sixth leading cause of chronic disease, with about 50 million sufferers each year in the United States, according to the National Institute of Allergy and Infectious Diseases.
"The approval of this widely-used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms," said Andrea Leonard-Segal, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA"s Center for Drug Evaluation and Research. "This approval reflects FDA's commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription.
Zyrtec-D"s common side effects include drowsiness, fatigue, and dry mouth. Sales of the drug are subject to restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product. Zyrtec-D is distributed by McNeil Consumer Healthcare, Fort Washington, Pa.
For more information:
Allergies and Hay Fever Fact Sheet
www.fda.gov/womens/getthefacts/allergies.html
FDA Consumer Magazine: "Itching for Some Allergy Relief?"
www.fda.gov/fdac/features/2002/302_itch.html
The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.
People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.
"FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines."
Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.
During the past year, FDA has carefully weighed several complex sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.
At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.
The revision of Avandia's existing boxed warning – FDA's strongest form of warning – includes the following statement:
A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.
The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.
GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.
To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.
Today's action follows recommendations made at the July 2007 joint meeting of FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.
For more information:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm
FDA Issues Safety Alert on Avandia
www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html
The Food and Drug Administration is announcing several steps to strengthen its advisory committee processes in ways consistent with recommendations of the Institute of Medicine. The measures include proposed new guidance or procedures on advisory committee voting, on disclosing information on conflicts of interest, and on security and appropriate conduct for participants at meetings. Other improvements include greater clarity to FDA’s advisory committee Web site, which can be found at http://www.fda.gov/oc/advisory/default.htm.
“One of FDA’s strengths is that we routinely enlist the nation’s leading experts to give us public advice on complex medical and scientific issues,” said Randall Lutter, Ph.D., deputy commissioner for policy. “The new steps we’re taking further enhance the transparency and reliability of our advisory committee processes.”
A draft guidance document being issued today recommends advisory committees adhere to a process of simultaneous voting, in which all members vote at once. The results of the vote would be announced immediately. How each member voted would be part of the public record. The draft guidance document is available at http://www.fda.gov/oc/advisory/votingguidance.html.
A second draft guidance issued recently lays out recommended changes to the process of public disclosure of financial interests that create conflicts of interest for advisory committee members. The new draft guidance makes the process more transparent and consistent by having all advisory committee members publicly disclose interests for which a waiver is granted. The draft guidance also includes redesigned disclosure and waiver templates that are clearer and easier for the general public to understand. The draft guidance document and redesigned templates are available at http://www.fda.gov/oc/advisory/waiver/ACdisclosure1007.html.
FDA also has formalized operating procedures designed to ensure appropriate security and promote proper decorum and public conduct at advisory committee meetings. They are intended to help ensure that meetings proceed in an orderly fashion and that the work of the committees is not impeded, but that the right of free speech is also protected.
In addition, FDA has improved its Web page on advisory committees by providing better access to information about waivers granted for conflicts of interest. This Web page provides current information about upcoming advisory committee meetings and other updated information related to FDA's advisory committee processes. The Web site is at http://www.fda.gov/oc/advisory/default.htm.
Finally, the FDA has recently posted the names of outside experts that it has named to a new risk communication advisory committee to make recommendations to FDA about how best to communicate the risks and benefits of FDA regulated products. More information about this advisory committee and the list of members can be found at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01739.html.
FDA’s policies on advisory committees continue to be informed by new studies on conflicts of interest. The agency asked a consultant, Eastern Research Group, to study 16 recent advisory committees. The report highlights the difficulty of assembling highly qualified experts who are free of conflicts and finds that those who have received waivers appear to be significantly more qualified than those who have not received waivers. The full report is available online at http://www.fda.gov/oc/advisory/ERGCOIreport.pdf.
So far this year the agency has convened 47 meetings of expert independent advisory committees to advise FDA on topics such as new gene therapies and the safety of children’s cough and cold medicines.
The U.S. Food and Drug Administration (FDA) today announced the board members and chair of the Reagan-Udall Foundation. The private and independent nonprofit organization will advance FDA's mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.
"The Reagan-Udall Foundation will be an important and independent vehicle for furthering the mission of FDA. By supporting public-private partnerships and other scientific collaborations, the foundation will enrich the agency and provide critical perspectives for the future," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "As FDA looks toward its future, the Reagan-Udall Foundation is in a unique position to understand, support and prepare the agency for that future."
"This foundation brings together an extraordinary group of leaders with diverse talents and experiences. The board members' combined backgrounds reflect the transformation and vision of FDA," said von Eschenbach.
In a demonstration of bipartisan support, the U.S. Congress mandated the foundation's creation in the Food and Drug Administration Amendments Act, passed in September 2007. The law requires that the foundation board of directors be established within 30 days and that it not include any federal employee.
Mark McClellan, M.D., Ph.D., director of the Engleberg Center for Health Care Reform at the Brookings Institution, former commissioner of FDA and former administrator of the Centers for Medicare and Medicaid Services, will chair the foundation.
McClellan said, "The foundation is an unprecedented opportunity to enlist broad-based support to accelerate scientific progress to help FDA fulfill its mission of protecting and promoting the public health—a mission that is more challenging but more important than ever."
"I look forward to a collaborative partnership with the board, the agency, legislators, and stakeholders to accelerate innovation that will improve the quality and safety of medical and food products," said McClellan.
In addition to McClellan, the new board members are:
"By agreeing to serve on the board, these distinguished representatives will help FDA continue to bridge scientific discovery into the development of safe and effective products," said von Eschenbach. "They reflect the areas served by FDA, all of which have a stake in a transparent and collaborative process. The broad representation from science, academia and industry in addition to strong Congressional support for this foundation is indicative of its mission, which will be about building the science of product safety."
The statute calls for a 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic, and biotechnology industries; three from academic research organizations; two from patient or consumer advocacy groups; one representing health care providers; and four at-large representatives with expertise or experience relevant to the foundation's purpose.
In addition, a majority of the foundation's board members—nine out of 14—must be appointed from a list of candidates provided by the National Academy of Sciences and the remaining five from nominations submitted by patient and consumer advocacy groups, professional scientific and medical societies and industry trade organizations.
As required by statute, four government health care officials—the commissioner of the FDA, the director of the National Institutes of Health, the director of the Centers for Disease Control and Prevention, and the director of the Agency for Health Care Research and Quality—appointed the board members from the two lists of candidates. The FDA commissioner and NIH director will continue participating in foundation activities as non-voting board members.
Congress established the Reagan-Udall Foundation to identify and address unmet scientific needs in the development, manufacture and evaluation of the safety and effectiveness of FDA-regulated products, including post-market evaluation. The foundation will establish scientific projects and programs to address those needs and help accomplish the scientific work FDA needs to support its regulatory mission.
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized today 12,682 applicator tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision. Authorities said the sales value ofthe seized tubes is approximately $2 million.
Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.
The FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. The agency takes seriously its responsibility to protect Americans from unapproved drugs.
FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye).
For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to decreased vision and possibly blindness.
In addition, use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema (swelling of the retina) and uveitis (inflammation in the eye), which may lead to decreased vision.
The U.S. Attorney's Office for the Northern District of California filed the complaint requesting the seizure, and coordinated with the FDA. The California Department of Public Health‘s Food and Drug Branch had previously embargoed the seized products at the San Jose facility. Jan Marini Skin Research has notified FDA that the company ceased manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost last year.
The FDA recommends that consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product. FDA also recommends that consumers consult their health care provider if they have experienced any adverse events that they suspect are related to the product's use.
The U.S. Food and Drug Administration today announced that it has approved Nexavar (sorafenib) for use in patients with a form of liver cancer known as hepatocellular carcinoma, when the cancer is inoperable. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidneycancer.
"In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug,” said Robert Justice, M.D., director of FDA's division of drug oncology products. "This is an important new treatment option for patients who are fighting this very difficult form of cancer."
According to the National Library of Medicine, hepatocellular carcinoma accounts for 80 to 90 percent of all liver cancers. This type of cancer can be difficult to remove completely using surgery. If all of the cancer cannot be removed, the disease is usually fatal within three to six months. The American Cancer Society estimates that there will be 19,160 new cases and 16,780 deaths from cancer of the liver and intrahepatic bile duct in the United States in 2007.
Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.
FDA's approval of Nexavar was based on the results of an international randomized placebo-controlled trial in patients with inoperable hepatocellular carcinoma. The study was designed to compare the survival of a group of patients who received the drug against a group of similar patients who did not.
A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial.
The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.
The most common adverse reactions that have been observed in patients taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or more of patients had experienced at least one of these reactions. In patients with hepatocellular carcinoma, diarrhea was reported in 55 percent of patients who received Nexavar. Inadequate blood supply to the heart or heart attack were reported in 2.7 percent of patients who received Nexavar, compared to 1.3 percent for patients who received placebo. New high blood pressure was reported in 9 percent of patients who received Nexavar, compared to 4 percent of patients who received placebo.
Elevated serum lipase, an enzyme that measures liver function, occurred in 40 percent of patients who received Nexavar, compared to 37 percent of patients who received placebo, and hypophosphatemia, or low blood levels of phosphate, occurred in 35 percent of patients who received Nexavar, compared to 11 percent of patients who received placebo.
Nexavar comes in 200 milligram tablets and the usual dose is two tablets (400 milligrams) taken twice a day on an empty stomach.
Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx Pharmaceuticals, Inc., Emeryville, Calif.
The U.S. Food and Drug Administration's Office of Regulatory Affairs (ORA) today announced the award of three lab grants, designed to boost the food screening capabilities and spot radioactive material in food, resulting from deliberate or accidental contamination. These labs are partof the Food Emergency Response Network (FERN).
The three-year grants provide $250,000 a year for supplies, personnel, minor facility upgrades and training. Recipients of the grants are the Texas Department of State Health Services Laboratory, the New York Health Research/New York Department of Health, and the Wisconsin State Laboratory of Hygiene.
FDA's ORA will expand its testing program to address the threat to food safety through radiological terrorism events. ORA has developed radiological screening and analysis methodologies used to evaluate foods and food products.
The grants are targeted toward enhanced detection of radiological contamination and thus enhance the nation's overall capability to rapidly detect and respond to deliberate attacks on the food supply.
The grant awards further expand the FDA's ability to promote the integrated strategy for protecting the nation's food supply through the three core elements of prevention, intervention, and response, as outlined in the agency's Food Protection Plan. These funded labs will be involved in food defense surveillance testing as well as bolstering the FDA's emergency response efforts by increasing the capacity for testing of foods for radioactive contamination, intentional or accidental.
The selected laboratories will receive funds to assist in acquiring supplies, personnel, and facility upgrades. The labs will receive training in current food testing methodologies, participate in method development and validation, proficiency testing, and food defense surveillance assignments.
Two key project areas have been identified for the grant recipients. These areas involve the detection of radioactive contamination, utilizing the most advanced detection systems available.
FERN's mission is to integrate the nation's food-testing laboratories at the local, state, and federal levels into a network able to respond to emergencies involving biological, chemical, or radiological food contamination. The network can respond to emergencies related to agents in food and restore the public's confidence in the food supply.
The U.S. Food and Drug Administration has approved tablet, chewable tablet, and syrup formulations of Zyrtec (cetirizine HCl) for nonprescription use. The nonprescription drug is approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older.
The nonprescription Zyrtec products also are approved for the relief of itching due to hives in people 6 years of age and older, including adults.
"The approval of Zyrtec for nonprescription use offers an additional treatment option for children and adults," said Andrea Leonard-Segal, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA's Center for Drug Evaluation and Research. "As for all nonprescription drugs, consumers and caregivers should read and carefully follow all directions on the labeling."
The tablets and chewable tablets are approved for adults and children 6 years of age and older:
The syrup is approved for:
The company will market two distinct Zyrtec products for each dosage form. One will provide directions for treating the symptoms of hay fever and other respiratory allergies. The other will contain directions for use to relieve the itching due to hives.
Zyrtec may cause drowsiness in some people at recommended doses. Other common side effects include fatigue and dry mouth.
On November 9, 2007, the FDA announced that it had approved Zyrtec-D, a product which contains cetirizine HCl and pseudoephedrine HCl, for nonprescription use. Sales of the Zyrtec-D are subject to restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product and that it be located with the pharmacist. Nonprescription Zyrtec-D was approved for the relief of symptoms due to hay fever or other upper respiratory allergies such as runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion. Zyrtec-D is also approved for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose due to hay fever and other upper respiratory allergies. Zyrtec-D is not approved for the relief of itching due to hives.
Zyrtec is marketed and distributed by McNeil Consumer Healthcare, based in Fort Washington, Pa.
Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid to smoking cessation treatment. An Early Communication reflects FDA’s current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.
FDA is evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription medicine to help adults stop smoking.
Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.
FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.
In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
FDA also advises that, due to reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix may affect them.
Full text of the Early Communication about the Ongoing Safety Review can be found at: http://www.fda.gov/cder/drug/early_comm/varenicline.htm.
The Food and Drug Administration today announced that it will be extending the comment period on the agency's proposed sunscreen regulation to Dec. 26, 2007. The comment period was set to expire on Nov. 26. Typically, comment periods for Federal rules is 90 days. The sunscreen rule, when finalized, will amend the 1999 FDA final rule on sunscreen products that protect against ultraviolet B (UVB) rays and incorporates new testing and labeling requirements for products that protect against ultraviolet A (UVA) rays.
On Aug. 27 the agency released to the public its proposed rule for over-the-counter (OTC) sunscreen products. FDA received nine requests to extend the comment period. One asked for an additional two months, eight for an additional nine months. The submissions cited the need for more time to complete laboratory testing and consumer studies on the proposed labeling system. By extending the comment period for 30 days, FDA is balancing industry concerns and the interests of public health to ensure that sunscreen products properly inform consumers of the level of protection they provide against UVA and UVB rays.
Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites:
Federal eRulemaking Portal: www.regulations.gov
FDA Web site: www.fda.gov/dockets/ecomments
Written submissions can be submitted by fax or mail:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Fax 301-827-6870
For more information:
FDA Web site for OTC drug products:
www.fda.gov/cder/Offices/OTC/consumer.htm