What Should Patients Do In Light of Avandia Restrictions?

San Francisco, CAFollowing the US Food and Drug Administration's announcement that it was severely restricting use of Avandia, and the European Medicines Agency's announcement that Avandia was being pulled from the market, patients in the US could be forgiven for wondering what they should do next. The move by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) shows that concern about Avandia side effects is far-reaching. But patients currently taking Avandia, and concerned about Avandia risks, might ask whether they should continue with the medication.

Although the FDA announced severe restrictions for Avandia use—patients put on the medication must be shown to be unresponsive to any other diabetes drugs on the market—the approximately 600,000 or so US patients who are currently taking Avandia will be allowed to continue, so long as they are provided with proper information about the medication and its risks.

Those risks include a reported increased risk of cardiovascular problems, including heart attacks and strokes. To ensure new patients are only given access to Avandia after all other pharmaceutical options have failed, GlaxoSmithKline, maker of Avandia, has been ordered to develop a risk evaluation and mitigation strategy (REMS).

Furthermore, according to Fortune (09/24/10), GlaxoSmithKline can no longer promote the drug.

What may surprise some people is that Avandia has been allowed to remain on the market, even with severe restrictions, when the EMA voted to pull the drug entirely. Doctors have until October 21 to ensure their patients are switched onto an alternative medication.

Fortune suggests that the reason the FDA has not ordered a full removal of Avandia from the market is that the studies are difficult to interpret, so more data is needed to definitively prove that Avandia has an increased risk of heart attack and strokes. Because the FDA has said that Avandia is dangerous, however, it cannot ethically allow further studies of the drug, as those studies could put patients at risk of serious side effects.

Without the adequate data to remove Avandia from the market—required by the FDA before a drug that has already been approved can be withdrawn—the FDA has chosen to severely limit its use. The FDA has also said that Avandia may be an important treatment for patients who cannot tolerate other diabetes medications.

Public Citizen, a public interest lobby group, blasted the FDA's decision not to pull Avandia entirely from the market. In a news release (09/23/10), Dr. Sidney Wolfe, Director, Public Citizen's Health Research Group, noted, "There is not a single study finding that Avandia is safer than Actos, but there are numerous studies finding that Avandia is more dangerous than Actos." Wolfe went on to say that the FDA and GlaxoSmithKline "acted recklessly" by allowing Avandia to stay on the market even after the risks associated with the medication were known.

Patients currently taking Avandia are being advised to switch medications, if possible. Any patients who have concerns about their Avandia use should speak to a medical professional about their concerns and should not discontinue medication on their own.