New FDA Restrictions Now Reflected on Avandia Label

Washington, DCSevere restrictions on Avandia announced in September by the US Food and Drug Administration (FDA) have finally made their way to the Avandia product label. According to a report by The Associated Press (AP) last night, the Avandia label (for US product) reflects the FDA recommendations that the Type 2 Diabetes drug is only intended for patients who are unable to control their blood sugar levels with any other diabetes medication.

Patients currently taking Avandia can only continue on the drug through consultation with and the approval of their doctor.

Avandia has gone from a blockbuster diabetes drug, with annual sales in the billions, to status as the pathway of last resort and used only with reluctance, due to risks for Avandia heart attack and other adverse reactions associated with the drug.

While Avandia has been banned outright by the European Union, the FDA has been reluctant to ask Avandia manufacturer GlaxoSmithKline to pull Avandia from the market here. Instead, an advisory panel in September decided in a close vote to allow Avandia to remain, albeit with severe restrictions, in spite of the various Avandia risks.

Those restrictions are now reflected on the Avandia label for US product.

According to AP, it took seven years for Avandia, approved in 1999, to achieve pharmaceutical superstardom with sales of more than $3 billion by 2006 (ironically, the level at which rival Actos is now). However, it took just about as long to determine the heart risks associated with Avandia due to the fact, says AP, that most diabetes patients are already predisposed to heart problems.

Risks have also been identified, according to reports, for Avandia liver failure and bone fractures. However, risk to the heart has been the one aspect of the Type 2 diabetes drug that has fostered the most concern, and the most controversy.

To that end, a Senate investigation last year concluded that GlaxoSmithKline knew about the risks associated with Avandia years before they became public, but withheld important data from the FDA. The manufacturer itself also reported late in 2010 that the Federal Justice Department and several state attorneys general are investigating the development and the marketing of Avandia.

While thousands of lawsuits brought against the manufacturer have already been settled, including lawsuits for Avandia death, additional lawsuits emerged following the announcement of more severe restrictions by the FDA in September according to AP, citing GlaxoSmithKline.

The FDA does not have the power to order a drug off the market—however, it can recommend a manufacturer do so voluntarily. The FDA has come close, but has not made that request. GlaxoSmithKline continues to stand behind its product, even amidst an expectation of continued loss of market share to rival Actos as a result of these latest label changes and restrictions, AP says. Of more than a dozen diabetes medications on the market, only Actos manufactured by Japan-based Takeda Pharmaceuticals works in the same fashion as Avandia. There is little doubt that Actos has benefitted from Avandia's misfortune.

AP cited data from IMS Health that revealed more than 900,000 US prescriptions for Avandia in the first half of 2010. That number is expected to shrink as patients and their doctors attempt to mitigate Avandia side effects by switching to other medications.