Avandia and pharmacovigilance

An interim analysis published by NEJM added new data to the previous meta-analysis and found that Avandia (Rosigilitazone) is associated with an increased risk of myocardial infarction.

BMJ published an editorial, "Rosiglitazone and implications for pharmacovigilance: postsurveillance data should be systematically collected and publicly available." Kazi D. BMJ 2007; 334: 1233-4 (16 June) and concluded that "the ongoing use of rosiglitazone merits careful deliberation." ( You can access the full text with an Athens password).

The author said that pharmacovigilance is the weakest in the regulatory processes of drug safety on both sides of the Atlantic and called for a radical change in the culture of existing regulatory agencies.

Avandia - an interim analysis

Following the concerns raised about the drug Avandia's heart risk, NEJM has published a report online on 5 June 2007 "Rosiglitazone evaluated for cardiovascular outcomes - an interim analysis " with new data that come from the RECORD trial, sponsored by the drugmaker Glaxo, designed to assess the drug's effect on the heart.

The authors concluded that the interim findings from this study were inclusive, "Rosiglitazone was associated with an increased risk of heart failure", but "the data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction."