FDA CellCept may cause birth defects
Mon, 29 Oct 2007 20:36:10 GMTWASHINGTON - A drug to prevent organ rejection in transplant patients may cause birth defects, health officials warned Monday.
The drug, called CellCept, also may cause miscarriages, the Food and Drug Administration added.
The FDA also warned that taking the drug, made by Switzerland's Roche Holding, may lower blood levels of the hormones in birth control pills, theoretically making them less effective at preventing pregnancy.
Women of childbearing potential should have a negative pregnancy test within a week of starting the immune-system suppressing drug, and must receive birth control counseling and use effective contraception, the FDA said.
Some doctors prescribe CellCept to lupus patients who cannot tolerate chemotherapy. The drug is known generically as mycophenolate mofetil.
FDA approves drug to treat leukemia
Mon, 29 Oct 2007 20:41:54 GMTWASHINGTON - A second-line drug to treat a life-threatening form of leukemia has won federal approval, the Food and Drug Administration said Monday.
Tasigna, known generically as nilotinib, won approval to treat chronic and accelerated phase Philadelphia chromosome-positive, chronic myeloid leukemia. The form of the blood cancer affects about 4,500 Americans a year.
FDA approval is specifically for use in patients who are resistant or intolerant to previous treatment, including with another drug called Gleevec also made by the Swiss pharmaceutical company Novartis AG.
Wyeth issues recall for cold medicines
Mon, 29 Oct 2007 20:40:17 GMTTRENTON, N.J. - Several nonprescription cold medicines are being pulled from store shelves after manufacturer Wyeth on Monday started a voluntary recall and replacement program at retail outlets nationwide.
The products are being removed because they come with a dosing cup that does not mark the half-teaspoon level recommended for children aged 2 through 5 years old, according to Wyeth Consumer Healthcare, a division of the Madison, N.J.-based drugmaker.
"There's nothing wrong with the products," said Wyeth spokesman Doug Petkus.
The products being recalled and replaced are: Robitussin Cough DM, Robitussin Cough & Cold CF, Robitussin Cough & Congestion, Robitussin Head & Chest Congestion PE, Robitussin Cough Sugar Free DM and Children's Dimetapp Cough & Chest Congestion.
The company is recommending that consumers with children in the 2 through 5 age group not use the medicines until replacement products with a new dosage cup are available. That will probably begin in early November, and the new boxes will be marked to indicate the replacement.
"It probably will take a couple months," Petkus said.
He said there are several million packages of those products in circulation, but there is no reason for consumers to seek a refund. No injuries related to the issue have been reported, Petkus said.
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On the Net: http://www.wyeth.com
Birth defects on rise in China province
Mon, 29 Oct 2007 20:54:06 GMTBEIJING - Coal mining regions of northern China are reporting soaring levels of defects in newborns, an apparent result of heavy pollution, state media said Monday.
Results from eight main coal mining areas in Shanxi province show levels far higher than the national average, according to a Xinhua News Agency report carried by the Beijing News.
"The rate of birth defects is related to environmental pollution," the report said, citing provincial population planning official An Huanxiao.
Shanxi is one of China's most heavily polluted regions, mainly as a result of mining and the use of high-sulfur coal.
No figures were given in the report, although data posted this month on the Web site of the government's National Population and Family Planning Commission said the national rate of birth defects increased by nearly 50 percent over 2001-2006, rising to 145.5 per 10,000 births.
Combined with other forms of visible defects and problems that don't show up until several months after birth, a total of 1.2 million children were born with defects every year, accounting for up to 6 percent of all children born, according to the data.
The commission gave no specific reasons for the increase, but urged medical authorities to better educate prospective parents and invest more in prevention and screening.
According to the U.S. National Institutes of Health, birth defects affect about one out of 33 babies in the United States.
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On the Net:
National Institutes of Health Web site: http://www.nlm.nih.gov/medlineplus/
Brain scans of obese show hunger hormone at work
Mon, 29 Oct 2007 21:35:46 GMTBy Maggie Fox, Health and Science Editor
WASHINGTON - Giving the body's natural appetite suppressant to morbidly obese volunteers de-activated their brain's response to tasty food -- and the new brain activity lasted for as long as the hormone was delivered, U.S. researchers reported on Monday.
They said their imaging tests show some of the brain circuits activated by leptin, a hormone that helps control appetite, and may lead to new and better treatments for obesity, the researchers wrote in their report, published in the Proceedings of the National Academy of Sciences.
&;While they were off leptin they got really hungry when they saw pictures of high-calorie food, and that was associated with high activation in a part of the brain that is related to food craving,&; said Edythe London of the University of California Los Angeles, who led the study.
With leptin, the executive centers involved in self-control were more activated. &;The findings suggest that leptin strengthens the executive centers,&; London said in a telephone interview.
The discovery of leptin in the 1990s created a furor, because when injected into rodents it caused them to eat less and lose weight. But the same rarely occurs in humans.
So experts are trying to find out how it works in people and find ways to better harness its effects.
London and colleagues examined three members of a family with a rare genetic defect that causes their bodies to produce no leptin. Such people become extremely obese.
Earlier studies had shown that when injected with leptin, these people lose up to 50 percent of their body weight -- unlike most people, who usually continue to over-eat even when injected with leptin.
London wanted to see what was going on in their brains.
&;In 2005 we found that leptin actually changes the structure of their brain,&; London said in a telephone interview. They found the area of the cerebral cortex involved in self-control actually grew after repeated leptin administrations.
But they wondered what else was going on.
They set up an experiment using functional magnetic resonance imaging, a type of brain scan that can see the brain's activity in real time. They recorded the brain activity before and after giving leptin, a study that continued for two years.
Pictures of food treats got the brain busy.
But different areas of the brain lit up with and without leptin, they reported.
One surprise was the activation of the cerebellum -- a section of the brain at the base of the head.
&;Although the cerebellum has not traditionally been linked with eating behavior, it is thought to play a role in reinforcement and drug craving,&; they wrote.
&;With leptin supplementation, the cerebellum showed enhanced activation,&; they wrote.
London said she is not sure what to make of this.
