Viles & Beckman Comments on FDA Panel's Decision to Recommend Avandia Warnings, Restrictions, Withdrawal

The Law Firm of Viles & Beckman is dedicated to keeping consumers abreast of the latest developments in regard to the FDA's increased scrutiny of the type 2 diabetes drug Avandia. A recent FDA panel's vote has recommended different warnings, restrictions and recall actions on this popular drug.

An FDA panel convened to investigate the safety of the type 2 diabetes drug Avandia (rosiglitazone) has concluded that the drug increases the risk of heart attack and should either be withdrawn from the market or subjected to increased control. In the final vote of the 33-member panel, 12 members voted to remove the drug from the market, 10 voted for increased warnings on the drug label combined with restrictions on the drug's use, and seven voted for increased warnings but no restrictions on its use. Only three panel members voted to make no change to the drug's status, while one member abstained from the vote.

This vote came after two days of hearings in which researchers presented evidence that Avandia is linked to an increased risk of heart attack, congestive heart failure and strokes. GlaxoSmithKline, the maker of Avandia, presented data from its clinical trials in order to prove that Avandia is safe when used as prescribed. However, several researchers, including FDA officials, have criticized GlaxoSmithKline's research as shoddy and biased. FDA researcher Dr. David Graham has described a GlaxoSmithKline study known as RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) as "garbage." In addition, GlaxoSmithKline has been accused of withholding information, submitting poor data and failing to collect information on patients who experienced problems while on Avandia, including patient deaths.

Avandia Side Effects

Avandia, which helps patients with type 2 diabetes process insulin more efficiently, has been under scrutiny for side effects for years, especially since 2007. That year, a review of several studies by Dr. Steven Nissen of the Cleveland Clinic found that Avandia raised the risk of heart attack by one-third as compared to patients taking a similarly acting drug, Actos, or a placebo. Other researchers have examined data from GlaxoSmithKline's own RECORD study and found a correlation between Avandia and congestive heart failure and stroke. Additional research has indicated an increased risk of death in Avandia patients, although the FDA panel determined there is insufficient evidence to conclusively support this link.

Avandia Legal Options

The FDA is expected to make a decision regarding Avandia in the coming weeks. In the meantime, patients who are taking Avandia should not stop the medication without speaking with their physician. However, patients who have suffered Avandia side effects, including Avandia heart attacks or congestive heart failure, are advised to consult with an attorney regarding possible legal action. Drug makers have a responsibility to thoroughly test their products and ensure their safety by means of ethical research that conforms to scientific protocols. If GlaxoSmithKline has failed to act responsibly in its research and marketing of Avandia, patients who have been harmed by the drug may have legal recourse. Even if the FDA decides to leave Avandia on the market, the drug maker can still be held accountable for the harm its product has caused.

If you or a loved one has suffered Avandia side effects, you may be eligible for financial compensation for missed work, medical bills and pain and suffering. The Avandia lawyers of Viles & Beckman are prepared to help with your case. Contact the firm today at 1-800-689-1094.