Healthy Skepticism Library item: 11035

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

NPS Avandia review
Pharmacy Daily (Australia) - registration required 2007 Jul 31
http://pharmacydaily.com.au

Full text:

THE National Prescribing Service is hedging its bets on diabetes treatment Avandia (rosiglitazone) after conducting a review of a recent meta-analysis of clinical trials of the drug (PD yesterday).

NPS has published a fact sheet ‘Rosiglitazone and cardiovascular risk’ covering its revew, and said that “the possibility of a small increase in cardiovascular risk should be borne in mind until further evidence becomes available”.

NPS ceo Lynn Weekes said it was difficult to draw firm conclusions about the metaanalysis, saying it had a “number of methodological weaknesses.

“Many of the trials included in the meta-analysis were not designed to assess cardiovascular risk and the authors had to rely on summary information posted on a clinical trial register rather than published papers,” she said.

But the NPS fact sheet states that both Avandia (rosiglitazone)and Actos (pioglitazone) are known to increase the risk of heart failure, adding that their in people at an increased risk of heart failure should be avoided.

MEANWHILE, the US FDA overnight held a hearing about Avandia, with advisers voting 22-1 in favour of keeping Avandia on the market, while acknowledging the risks of the medication.