EMA pulls Avandia; FDA restricts use

Should Avandia stay or should it go? Drug regulators on both sides of the Atlantic today issued their rulings on the GlaxoSmithKline diabetes drug, after months of review on its safety. And while one agency--the FDA--determined that the drug could stay, albeit with "significant restrictions, the other said it has to go.

In near-simultaneous announcements, the FDA and European Medicines Agency delivered the news on Avandia, decisions that have been highly anticipated for months now. Calling the drug's cardiovascular safety "an open question," FDA said it would allow Avandia to remain on the market, but under a new, as-yet-to-be-designed restricted-access program. The risk-management plan would require a risk assessment of each patient; documentation that it's Avandia the patient really needs; and enrollment by doctors, pharmacists and patients. 

EMA came to a different conclusion: "[O]verall, the accumulated data support an increased cardiovascular risk of rosiglitazone," the agency said in a statement. In light of the fact that Avandia was already subject to various restrictions, the agency couldn't identify any further measures that would reduce that risk. "The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks," the EMA's statement says. So, Avandia and two sister medications will no longer be available in Europe within a few months; the agency advised patients to see their doctors about alternative treatments.

Avandia has been under fire since May 2007, when Cleveland Clinic cardiologist Steve Nissen authored a now-notorious study linking the diabetes drug with cardiovascular risks, including heart attack. FDA ratcheted up warnings on the drug, but some experts continued to call for its withdrawal, including a few of the FDA's own scientists. Meanwhile, GSK pointed to other data, from the "best-designed and -conducted studies," that didn't show increased risks.

European regulators and FDA's expert advisors met separately over the summer to consider some new data, including another meta-analysis that showed Avandia patients experienced more CV problems than patients taking other drugs. The debate at FDA's advisory panel meeting was intense, and the final vote showed just how split the committee was: Some voted for withdrawal, some for increased warnings and restrictions on the drug, some for new warnings only, and three for the status quo.

- read GSK's statement
- see the FDA statement (pdf)
- get the EMA announcement