What Will 2011 Bring for Avandia?

January 7, 2011, 1:30PM. By Heidi Turner

Seattle, WALast year was a tough year for Avandia maker GlaxoSmithKline. Between allegations of downplaying Avandia side effects, settling approximately 10,000 Avandia lawsuits and having the drug's use severely restricted by the US Food and Drug Administration (FDA) because of Avandia risks, which include a risk of Avandia heart attack, 2010 was a difficult year for GlaxoSmithKline. Now that Avandia's use has been greatly limited, both in the US and overseas, it remains to be seen how Avandia will fare in 2011.

Back in February 2010, GlaxoSmithKline was hit by government reports that alleged the company knew about the cardiac risks associated with Avandia, a diabetes medication, well before it alerted the public to those risks. The government reports further alleged that rather than simply trying to downplay the risks of Avandia, GlaxoSmithKline also attempted to minimize findings that a similar drug, made by a competitor, could reduce those same risks.

At the time, GlaxoSmithKline issued a statement that the US Senate staff report was inaccurate and that the drug's safety and effectiveness were properly studied.

Meanwhile, however, researchers called an ongoing study of Avandia, designed to compare its safety with that of rival drug Actos, "unethical and exploitative." Researchers called for the trial to be halted, saying patients in the trial would be exposed to unnecessary risk by being placed on Avandia instead of on Actos, which had not been linked to heart problems. The trial, known as the TIDE trial, was halted by the FDA, while independent assessment into GlaxoSmithKline's RECORD trial—a different Avandia study—has been ordered.

Since the Senate report was released, the FDA put together an expert panel to advise the administration as to how to deal with Avandia. Although the panel voted to keep Avandia on the market, it also voted to severely restrict the drug's uses. The FDA followed the panel's recommendations, requiring doctors and patients to show they are fully aware of all Avandia side effects before using the medication. Furthermore, new Avandia patients must have tried every other diabetes medication available before taking Avandia (patients who are currently on Avandia will be allowed to choose whether or not to continue).

The FDA said Avandia would remain on the market because of conflicting data about the risk of cardiac side effects and because some individuals may still benefit from the medication when no other medication will help them.

How many patients have or will decide to remain on Avandia is yet to be seen. Although GlaxoSmithKline settled approximately 10,000 Avandia lawsuits for a total of around $460 million, approximately 3,000 more lawsuits are still pending.