Avandia Remains on Market but with Additional Warning
The US FDA has recommended that Avandia (rosiglitazone) be allowed to remain on market. However, additional warning has been inserted in the existing boxed warning in the product’s labeling. The new warning highlights the potential increased risk for cardiovascular events, especially myocardial infarction [1].
Avandia, manufactured by GlaxoSmithKline (GSK), was approved for marketing in 1999 in the US as oral treatment for type-2 diabetes mellitus. It has the advantage that it can be used as a stand-alone therapy or as co-therapy with other oral anti-diabetes treatments.
An article in NEJM early this year reported a meta-analysis of 42 randomized controlled clinical trials on rosaglitazone. The results show that “rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance.” [2]
The FDA has requested GSK to conduct a new long-term postmarketing study to evaluate the potential cardiovascular risk of Avandia and the manufacturer agreed to comply [1]. The study is expected to be concluded by 2014.
Sources:
One Comment
- CVD News Watch for the Weekend 11 July 2008 | Battling Heart and Stroke replied:
[…] After Avandia, the FDA is more wary about diabetic drugs. The regulatory body would require more clinical studies on new diabetes drugs to rule out cardiovascular risk before they can be approved for marketing. […]
July 10th, 2008 at 11:15 pm. Permalink.