GSK revises US label for Avandia

GlaxoSmithKline (GSK) has announced that it is to revise the US product label for Avandia (rosiglitazone maleate) following an extensive review by the US Food and Drug Association (FDA).

Following a detailed study of Avandia’s myocardial ischemia data, GSK has adopted a number of FDA recommendations.

The FDA found that while an association was found between Avandia and an increase in myocardial ischemic events, the risk was not confirmed or excluded in three-long clinical trials comparing Avanida against a placebo.

Consequently the boxed warning on the Avandia label will state that available data on the risk of myocardial ischemia is inconclusive.

Other revisions that have been implemented following FDA recommendations include a label update stating that Avandia is not recommended for use with patients who are taking insulin or nitrates.

Dr Ronald Krall, GSK’s chief medical officer, emphasised that Avandia remained a valuable medicine for patients with type 2 diabetes and had an appropriate safety and effectiveness profile when used according to the labelling.

“Given the severity of this disease and the importance of Avandia in helping patients manage their diabetes, we will continue to work with the FDA to conduct more studies about the safety and benefits of our medicine,” he confirmed.

Last month, GSK announced that Andrew Witty would be joining the company as chief executive officer designate.