Category Archives: Avandia and the FDA
Glaxo’s Diabetes Drug Avandia Pulled From U.S. Pharmacies
Avandia Recall
Beginning in November, the popular diabetes drug, Avandia, will be removed from your local pharmacy’s shelves, the federal government said Tuesday, due to the Avandia Recall.
Avandia Recall – New Program Begins Novemeber 18
The new program will take effect November 18, at which point only certified doctors may prescribe the drug and only patients who know the risks and are filling their prescription through the mail from specific pharmacies may receive the drug, USA Today reported.
A 2007 analysis published by Nissan showed the diabetes drug increased the risk of heart attack by about 40 percent in type 2 diabetes patients, who already have a heightened risk of heart attacks because of the disease.
FDA drug-safety expert David Graham told an advisory committee in 2007 that Avandia had caused heart problems, including deaths, in 66,000 to 200,000 people.
Avandia Recall: Trade Name Rosiglitazone
Avandia is the trade name for the drug rosiglitazone, which is on the market as part of the combination drugs Avandamet and Avandaryl. Nearly half a million patients in the USA filled prescriptions for these products from January through October of 2010.
Avandia was approved in 1999 to decrease blood-sugar levels in people with type 2 diabetes.
Type 2 diabetes affects about 23 million Americans, will you be affected by the Avandia Recall?
Avandia Lawsuits Triggered due to Warning
GlaxoSmithKline PLC said it has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug’s links to heart attack.
The Food and Drug Administration announced the changes last September as the last in a series of safety actions against the former blockbuster drug, which has triggered thousands of patient lawsuits and a Department of Justice investigation. The European Union has banned the drug.
The new U.S. label indicates that Avandia is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market. Patients who are currently on the drug can continue taking it after consulting with their doctor.
While there are more than a dozen diabetes drugs on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia. U.S sales of Actos have risen steadily — hitting $3.4 billion in 2009 — as Avandia’s reputation has soured.
Avandia Sales Plummet
The FDA first approved Avandia in 1999 and it became the top-selling diabetes pill in the world, with more than $3 billion in sales by 2006. But use has plummeted since a 2007 analysis first linked the drug to heart attack.
Determining Avandia’s heart risk was a painstaking process that dragged on for years because most patients taking the drug are already predisposed to heart problems due to diabetes.
Have you Suffered any Side Effects from Avandia?
If you or a loved one has taken Avandia and has suffered any of the harmful side effects associated with Avandia, you may have a claim. Please fill out the Free Case Review Form to the right and we will have an experienced Avandia Attoeny contact you to discuss your options.