FDA Panel Votes for More Restrictions on Avandia
On July 15, 2010, an FDA advisory panel researching the risks of Avandia side effects recommended that the type 2 diabetes drug be removed from the market or more tightly regulated. Of the 33 experts on the panel, 12 voted that the drug be taken off the market, 10 voted for restrictions on its use combined with stronger warnings on its label, and seven voted for enhanced warnings but no restrictions on its use. Only three members voted to leave the status of the drug as is. (The final voter abstained.)
The vote came after two days of heated discussion in which researchers and representatives of GlaxoSmithKline, the manufacturer of Avandia, presented conflicting information. Some experts cited evidence that Avandia increases the risk of heart attack, congestive heart failure and stroke when compared to other drugs on the market. GlaxoSmithKline countered with data from its own trials, most notably RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) to demonstrate the safety of the drug. However, some FDA officials harshly criticized GlaxoSmithKline's research, claiming their studies were improperly conducted and that GlaxoSmithKline has withheld information and manipulated data in order to minimize the risks of Avandia.
The advisory vote is nonbinding. However, FDA director Dr. Janet Woodcock has stated that the agency will consider the panel's recommendation and will make a decision in the following weeks. Some experts contend that the panel has given the FDA the ammunition it needs to remove Avandia from the market.
Others maintain that even if the FDA decides to keep Avandia on the shelves, the panel's vote and the negative publicity surrounding Avandia have already undermined the drug's legitimacy in the eyes of patients and physicians. Indeed, the number of prescriptions for Avandia decreased from 13 million in 2006 to 2.6 million in 2009 as concerns about Avandia heart attacks, strokes and deaths have increased.
Discussing Your Case with an Avandia Lawyer
Even if the FDA takes no action and leaves Avandia on the market with its current warning labels, GlaxoSmithKline can still be held accountable for the damage caused by its product. If the drug company has failed in its responsibility to protect the public from the harmful effects of Avandia, the company may be held liable for damages. If you or a loved one has been harmed by Avandia, you may be able to receive financial compensation for lost wages, medical expenses and pain and suffering. To explore your legal options, please contact the Avandia lawyers. A skilled personal injury attorney can help you obtain justice for you or your loved one.
Page Updated July 23, 2010
