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The US and European regulatory watchdogs for drug safety have issued safety advisory to both healthcare professionals and public about the risks of GSK’s Avandia (rosiglitazone).

Issued on May 21 and May 23 respectively, the press release press releases by these 2 influential agencies drew reference to the recently published article in NEJM. The article analysed 42 studies which reported small elevated risks of cardiovascular events, including myocardial infarction and cardiovascular death, among  type II diabetics treated with rosiglitazone marketed by GSK. The article concluded that Avandia increased the risk of heart attack by 43 % and cardiac-related death by 64 %.

Patients receiving such treatment were advised not to stop the treatment but to discussed with their  healthcare professionals about the potential safety issue related to rosiglitazone on their next visit.. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus.

Avandia is GSK’s second-biggest seller, bringing in £1.6 billion (US$3.16 billion) and accounting for 7% of group revenues -- and significantly more of profits -- in 2006.

 

 

 

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