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Another Diabetic Drug Disaster
Sunday, 10 June 2007 - 12:20 AM SL Time | | |
FDA Issues Safety Alert on Diabetes Drug
By MARILYNN MARCHIONE, AP Medical Writer
Monday, May 21, 2007
The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, and the U.S. government issued a safety alert Monday.
The Food and Drug Administration urged diabetics taking the pill to talk to their doctors, but stopped short of forcing a sharper warning label on the drug sold by GlaxoSmithKline PLC of London.
More than 6 million people worldwide have taken the drug since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack, according to the review published by the New England Journal of Medicine.
Experts said the overall risk was small and cautioned people not to stop taking the drug on their own but to talk to their doctors.
The company downplayed the report of heart risks, saying the analysis by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic is not definitive scientific proof. In a conference call Monday, Dr. Lawson McCartney who leads Glaxo`s diabetes drug development, said the company is not seeing `anything like` the problems reported in the medical journal.
`We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine,` McCartney said.
The government will take no immediate action on a label change or other measures regarding the drug, said Dr. Robert J. Meyer of the FDA`s Center for Drug Evaluation and Research.
Some data suggests `that there is a potentially significant increase in the risk` but there also is risk if patients switch drugs or do not keep their blood-sugar under control, an FDA statement says.
FDA officials acknowledged that Glaxo submitted information last August indicating some increased risk from the drug but that other studies were contradictory. However, several members of Congress expressed alarm and said they would hold hearings on the safety issues.
Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity and afflicts 18 million Americans and 200 million people worldwide.
For more go to: http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2007/05/21/national/a114606D15.DTL |
Source(s)
http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2007/05/21/national/a114606D15.DTL |
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