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Avandia Facing More Limitations
Boston, MA: As Avandia's sales drop, more news is coming in that uses of the drug both in the US and internationally are being limited. GlaxoSmithKline, maker of Avandia, already faces numerous [lawsuits] regarding the drug; sales have fallen drastically and now it appears that even fewer people will have access to Avandia because of safety concerns.
The Department of Veterans Affairs has decided to remove Avandia from the VA drug formulary (its list of approved drugs), after months of debate over Avandia's safety. The VA made up approximately eight percent of Avandia's sales. Although the VA will continue to make Avandia available for current patients who wanted to continue with the drug, the organization is urging doctors to discuss the drug's safety issues with those patients. Furthermore, patients who do not currently take Avandia will not be able to do so in the future. According to a VA statement, "The Department of Veterans Affairs conducted its own review and has concluded that, for some patients, rosiglitazone [Avandia] may not afford the same margin of safety as alternative drug therapies."
 If many VA patients decide to stop taking Avandia and switch to something else, GlaxoSmithKline could see a huge drop in sales. According to one report, between September 2006 and August 2007, the VA issued over 161,000 Avandia prescriptions.
Meanwhile, Avandia is facing international restrictions as well. The European Medicines Agency (EMA) has recommended a tighter label for the drug. The new label will include a warning that patients with ischemic heart disease should only be given Avandia after a careful individual examination that considers the health risks associated with the drug. Furthermore, the label will advise that Avandia and insulin should only be combined in exceptional cases and with close supervision. Finally, the EMA recommended that further studies be performed to determine the risk of using Avandia.
Some reports estimate that Avandia sales in the US have dropped by 60 percent since a study published in May revealed a 40 percent increased risk of heart attack in patients taking Avandia. Prior to the study's publication, approximately one million prescriptions were written for Avandia each month.
The US Food and Drug Administration (FDA) has an ongoing safety review of Avandia. According to an article in the New York Times (October 18, 2007), Dr. David Graham, a safety officer at the FDA argued that Avandia has caused up to 205,000 heart attacks and strokes since it was approved to treat type 2 diabetes in 1999. Although Avandia is still on the market, some FDA officials argue that the drug should be withdrawn.
Lawsuits have been filed against GlaxoSmithKline alleging the company knew about the risks associated with Avandia but failed to make that information available to the public.
Avandia Legal Help If you or a family member have used Avandia and have suffered heart attack or liver damage after taking Avandia, please contact a lawyer involved in a possible [Avandia Lawsuit] who will review your case at no cost or obligation.
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