Avandia is Gone   (September 23, 2010)

In simultaneous announcements, the FDA and the European Medicines Agency have decided to remove/restrict the use of Avandia and other drugs containing rosiglitazone. I've discussed the reason why several times earlier: it's because these drugs increase the risk of cardiovascular events as well as lowering blood glucose levels.

The FDA has allowed patients already on Avandia to continue on it, but essentially disallowed new starts, restricting new use to "patients not already taking rosiglitazone who are unable to achieve glycemic control on other medications and, in consultation with their health care professional, decide not to take pioglitazone for medical reasons." Whether a new patient or a patient already on Avandia, the physicians need to document in the medical record that the patient has been informed of "complete risk information." In addition, the FDA stopped the TIDE study and another earlier study (RECORD) will be reevaluated.

In Europe, the EMA was even firmer: "The European Medicines Agency today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months." Doctors were advised to not prescribe these drugs, and to plan to transition patients on them to alternative therapy. Technically, the EMA suspended the use of the drugs until the manufacturer provides "convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks" (which, to my thinking, is about as likely as finding that the moon is made of green cheese).

If you are taking Avandia, what to do? The EMA said it best: "Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor." For most patients, Actos (pioglitazone), which is in the same class of drugs (the "glitazones") would be a logical choice; for some patients with poor control, it's time to start insulin, and for other patients with excellent control, a trial without diabetes medications might be appropriate.

If you are the manufacturer, what should you do? I've said it before, and I'll say it again:

"Avandia (rosiglitazone) [should] be voluntarily taken off the market. Avandia has had cardiac safety problems resulting in label changes and it is becoming less-and-less profitable for the manufacturer. In an unexpected fit of ethics, the manufacturer would make it clear that they consider ethics more important than satisfying their shareholders. FDA officials, newspaper editors, and financial analysts worldwide will be utterly amazed."