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-October 18, 2007
GlaxoSmithKline suffered another blow this week when the Department of Veterans Affairs announced that it planned to restrict use of Avandia , the company's blockbuster type 2 diabetes drug.
“The Department of Veterans Affairs conducted its own review and has concluded that, for some patients, (Avandia) may not afford the same margin of safety as alternative drug therapies,” an agency statement said.
Plummeting Prescriptions
Approximately one million prescriptions were written for Avandia before a study published in May linked the drug to a 40 percent increased risk of heart attack, according to a pharmaceuticals analyst.
From September 2006 to August 2007, the V.A. issued more than 160,000 prescriptions for the drug. Glaxo spokeswoman Mary Anne Rhyne said the agency's prescriptions account for eight percent of total Avandia sales.
Since the May article questioned the drug's safety, sales of Avandia have plummeted about 60 percent. The article was based on an analysis of various clinical trials and was written by leading cardiologist Dr. Steven Nissen and his Cleveland Clinic colleagues.
FDA Safety Review
Glaxo denies that the risk of heart attack with Avandia is higher than other oral diabetes medications. However, a second study published in September confirmed Dr. Nissen's findings.
The Food and Drug Administration is currently reviewing the drug, and in July, an advisory panel recommended that Avandia remain on the market despite its risks. The FDA is not bound by the panel's recommendations, and agency officials are split on the issue.
Dr. David Graham, a safety office at the FDA, said that Avandia is responsible for as many as 205,000 heart attacks and strokes over the past eight years. The drug gained FDA approval in 1999.
V.A. Decision
The V.A. said it would allow patients who are already taking Avandia to remain on the drug if they so choose.
“The V.A. will not provide it to patients for whom it is not currently prescribed,” said the agency.
(Source: New York Times online)
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