The Diabetes Drug Avandia May be Pulled from the Market
A 1997 public meta-analysis of Glaxo-SmithKline’s diabetes drug Avandia has caused the drug to come under public fire. This analysis showed that the medicine increased the risk of heart attacks for patients taking the medication, which resulted in the placement of a black box warning on the drug’s outer label. Now, Avandia has been shown to induce liver failure, and a black box warning has been added to the label that advises users of this particular adverse event, as well.
The result of these updated warnings has been that a few well-known physician associations have recommended against using the drug Avandia. Guidelines recently issued by the American Diabetes Association and the European Association for the Study of Diabetes said that joint medical panel members “unanimously advised against using Avandia”. On October 30, after this recommendation, Public Citizen asked that FDA ban the drug. FDA officials have since indicated that there is a split within the agency on whether or not to pull Avandia off of the market, or perhaps to allow it to stay if it carries stronger user warnings. Public Citizen believes that the FDA should ban the diabetes drug Avandia due to its variety of life-threatening risks, including significant heart and liver damage. This consumer group filed a petition with the Food and Drug Administration to have Avandia removed from the market, stating, “The FDA is in possession of unequivocal, clear evidence that Avandia causes a wide variety of toxicities. Many of these are life threatening, such as heart attacks, heart and liver failure.”
It was only a few years ago that Avandia’s heart risks were first brought to light, when a respected medical journal article reported a 43% higher risk of heart attacks among Avandia patients over those taking other diabetes drugs. Scientists are still debating the link between the drug and the subsequent heart attacks, but concerns about the available medical evidence have led to stronger warnings. As a result of these concerns, Avandia use has dropped dramatically, but about a million U.S. patients continue to take it. Public Citizen’s research has found over a dozen cases of liver failure among Avandia patients, 12 of which have led to patient death. Avandia also predisposes some diabetic patients to eye problems, bone fractures and anemia.
Glaxo-SmithKline continues to say that it does not believe that Avandia causes liver failure—in fact, the company says its own data shows that the drug has a good safety record in the area of liver problems. The company claims that the data on heart attacks is actually inconclusive and that the drug is safe and effective when used properly. Public Citizen questions why the FDA is waiting to act on banning Avandia when there is solid medical evidence that questions its safety, and approximately ten thousand prescriptions for the drug continue to be filled daily. For additional information on the federal regulation of prescription drugs, contact the legal professionals at Cartwright Law Firm.
SOURCE: WALL STREET JOURNAL and ASSOCIATED PRESS