FDA Heparin illnesses now in Germany
Fri, 07 Mar 2008 03:14:12 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - Dialysis patients in Germany have gotten sick using a different brand of the blood thinner heparin than was linked to 19 American deaths, U.S. officials announced Thursday, sparking concern that the problem could be more widespread than originally believed.
In reaction, the Food and Drug Administration urged all U.S. suppliers of heparin to start using some special high-tech tests to make sure their products are free of a contaminant that is the prime suspect for hundreds of allergic-type reactions linked to Baxter International's U.S.-sold heparin injections.
Baxter wasn't implicated in the German illnesses, and that's what raises the question of a bigger heparin problem.
Instead, the FDA said that Germany is recalling heparin made by a German company that uses a different supplier of raw heparin ingredients than Baxter does.
Heparin is derived from pig intestines, and Baxter gets its supply from China, which is the world's leading source of heparin. The FDA wouldn't say whether the German company, which it identified as RotexMedica GmbH, also bought from a Chinese supplier.
Nor was it clear whether Germany has started testing its drug version for the contaminant, a compound that mimics heparin so precisely that it's not detected by standard drug-quality tests.
The FDA posted on its Web site Thursday instructions for how manufacturers can do additional specialized testing for the fake ingredient.
"We're concerned about, worldwide, this contaminant in heparin and making sure it stays out of the heparin supply," the FDA's chief medical officer, Dr. Janet Woodcock, said. "With this testing method, there'll be a way to protect the heparin supply."
German authorities were looking into the report of a contamination but would not confirm that the product had been recalled, said a German government official who requested anonymity because he was not authorized to speak about the matter.
Large doses of heparin are used for dialysis and heart surgery. Baxter competitor APP Pharmaceuticals is now the sole maker of those injections, and the FDA said APP's supply so far has tested contaminant-free.
But there are other smaller heparin manufacturers who sell the drug for different uses in the U.S., and the FDA wants them to test their supplies as well.
Woodcock said German health authorities notified their U.S. counterparts Thursday morning, reporting fewer than 100 illnesses and no deaths. But the illnesses were the same kind linked to the U.S.-recalled heparin, including allergic-type problems with breathing and low blood pressure, she said.
Baxter buys its heparin through Wisconsin-based Scientific Protein Laboratories, or SPL, which in turn owns a Chinese factory — Changzhou SPL — and buys additional raw heparin from other Chinese suppliers.
The German situation "demonstrates that the heparin problem is not within Changzhou SPL's or Baxter's manufacturing facilities, but our investigation into the root cause of the problem will continue," Scientific Protein Laboratories said in a statement Thursday.
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Associated Press writer Desmond Butler contributed to this report.
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On the Net:
Food and Drug Administration: http://www.fda.gov
Vegas hepatitis exposure list incomplete
Fri, 07 Mar 2008 04:47:12 GMTBy KATHLEEN HENNESSEY, Associated Press Writer
LAS VEGAS - The unsafe medical procedures that spread hepatitis C among patients at a large Las Vegas surgical clinic may be more widespread and may have resulted in more infections than first believed, health officials said Thursday.
Health inspections at 13 other outpatient surgical centers in the Las Vegas area found several violations of standard practices, Lisa Jones, head of the state licensing bureau, testified to a legislative committee on health care.
"We're finding problems at a variety of different levels — medication reuse, in some cases syringe reuse in different procedures and functions. That's why one of our very first actions is the need to get the word out on the street," Jones said.
She would not comment more precisely on the nature of violations in other surgical centers.
The public hearing was the first investigating an outbreak of the hepatitis C virus traced to the Endoscopy Center of Southern Nevada. Six patients have been diagnosed with acute hepatitis C. The surgical center and five affiliated clinics have been closed, and five nurses have surrendered their licenses.
In the largest patient notification effort in U.S. history, nearly 40,000 people treated at the center from March 2004 to mid-January were sent letters telling them they are at risk for exposure and should be tested for hepatitis, strands B and C, and HIV.
Legislators also were told that some patients have not been notified because the Endoscopy Center did not provide a complete list of patients and investigators can't be sure when the unsafe practices began.
Hepatitis is a potentially fatal, blood-borne virus that causes inflammation of the liver and can lead to stomach pain, fatigue and jaundice. It goes undetected in as many as 80 percent of cases.
Health officials believe the virus was spread when clinic staff regularly reused syringes and vials of anesthesia intended to be used on one patient. Clinic staff told inspectors that the practice was ordered by management.
Inspectors also saw staff members inappropriately cleaning two scopes in one solution, officials said.
Health District chief Lawrence Sands said those practices are "unacceptable" and "should never have happened." Sands said reusing syringes and vials of medication was a well-known violation of common safety standards, and he called for better oversight, whistleblower protection and education within the medical community.
The clinic's majority owner, Dipak Desai, has refused to comment.
He released a statement expressing concern for the patients and assuring the public the problems had been corrected. He later took out a full-page ad in Sunday's edition of the Las Vegas Review-Journal insisting that needles had not been reused and that the chances of contracting an infection at the center in most of the past four years were "extremely low."
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On the Net: Southern Nevada Health District: http://www.southernnevadahealthdistrict.org/
Senate OKs tougher overseas toy checks
Fri, 07 Mar 2008 03:15:08 GMTBy LAURIE KELLMAN, Associated Press Writer
WASHINGTON - Responding to record recalls of products that sickened children, the Senate passed legislation Thursday that would toughen inspections of toys and other playthings made outside the U.S.
The bill calls for a public database of consumer complaints, bolsters the Consumer Products Safety Commission to help it certify the safety of overseas products, bans lead in children's goods and sets new standards for safe toys.
It won approval by a 79-13 vote after four days of debate. The Bush administration and other critics said the database unfairly could taint manufacturers. But President Bush stopped short of threatening a veto.
Both the Senate and House versions passed with veto-proof margins, increasing the chances a compromise would draw similar support.
"Even though doesn't like it, I think he's going to have to take it," Senate Majority Leader Harry Reid, D-Nev., told reporters during a conference call.
Congress has much to do before Bush has the chance to make that decision.
"The hard work starts" now, said Sen. Mark Pryor, D-Ark., with negotiators from each chamber working to reconcile their differences. He managed the bill with Sen. Amy Klobuchar, D-Minn.
The House's version, passed by a 407-0 vote in December, has many differences, including a lower cap for jury awards. Regarding the database, the House version proposes a study on how to create one.
The congressional debate was thick with emotion. The mothers of two boys sickened by toys tearfully urged Congress to speed the legislation to the president, saying many provisions would have helped her children and prevent others from similar dangers.
For Colton Burkhart's parents, it was a medallion from a gumball-type machine that cost just a quarter, but nearly took his life.
Colton, then 4, swallowed the trinket and almost died from the lead it contained. Four years and a battery of tests, surgeries and therapy later, the Redmond, Ore., boy still has elevated levels of lead in his body.
Colton's mother, Kara, visited the Senate this week to tell anyone who would listen about Colton's ordeal. But Colton fared better than another 4-year-old, Jarnell Graham of Minneapolis, who died from lead poisoning under similar circumstances.
It was their cases — and hundreds like them — that spurred the recalls last year of millions of Chinese-produced toys, from Barbie doll accessories to Thomas the Tank Engine. Congress, in turn, produced legislation that would overhaul the Consumer Products Safety Commission, responsible for ensuring that toys and other products pose no hazard.
Klobuchar and Pryor said the legislation was written in close consultation from some of the retailers who had to pull recalled products from store shelves.
"We believe that stronger federal quality assurance standards will play a critical role in achieving what we all are striving for: the safest possible products for our children," Toys "R" Us Inc. said in a statement after the Senate vote.
The Senate bill would nearly double the agency's budget and increase its staff to nearly 500 people by 2013.
The new database would collect information from people, hospitals and other sources about injuries, illnesses and deaths from consumer products.
The Senate bill would raise the civil penalty cap per violation from $8,000 to $250,000 and the limit for a related series of violations from $1.8 million to $20 million; the House version would raise the penalty limit to $10 million.
The final Senate bill included amendments, including one by Klobuchar that would prohibit agency staff from taking trips paid for by companies and industries they regulate.
Also included was an amendment by Sen. Dianne Feinstein, D-Calif., that would ban phthalates — chemicals in plastic that can cause health problems — in children's toys and products.
The administration issued a statement this week citing half-dozen provisions about which it had various levels of concern, but none serious enough to merit a veto.
The agency, according to the administration, should enforce safety standards, not attorneys general as the Senate version proposes. Also, new legal shields for whistleblowers "will cause a serious increase in the number of frivolous claims brought against employers," the statement said.
The White House said it was concerned about a requirement that toys be tested by independent and privately owned third parties.
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On the Net:
Information on the House bill, H.R. 4040, and the Senate bill, S. 2663, can be found at http://thomas.loc.gov.
