As the FDA (Food and Drug Administration) advisory panel prepares to meet next week to discuss the safety of Avandia (Rosiglitazone), an anti-diabetic insulin sensitizer drug, FDA scientists continue to question its safety. The endocrinologic and metabolic advisory committees meet this Wednesday. They will also vote on whether they think the drug should remain on the market.

Although the Committee’s decision is not binding, the FDA tends to do go along with their recommendations.

An article in JAMA (Journal of the American Medical Association) in June 2010 reported that patients aged at least 65 years who have diabetes type 2 and take Avandia have a higher risk of developing stroke, heart failure, and even dying compared to similar patients who take Actos (Pioglitazone). (Link).

An article in NEJM (New England Journal of Medicine) in 2007 reported that Avandia increased heart attack risks by 40%.

GlaxoSmithline (GSK), the makers and marketers of Avandia, released a company-funded study (Record) involving 4,500 patients that showed no increase in heart attack risk. In the study, participants were given either Avandia, Merformin or Sulfonylurea for over 5 years.

According to FDA scientists, the GSK-funded study was “inadequately designed and conducted to provide any reassurance about the CV (cardiovasular safety) of rosiglitazone.”

Concern regarding the adverse events of Avandia has reduced its use, despite its sustained effects on glycemic control. While some FDA reviewers had voiced concern over the death rate of Avandia compared to Actos (pioglitazone), and had recommended that it be taken off the shelves, an FDA panel disagreed, and it has remained on the market. It will be interesting to hear what the conclusion of next Wednesday’s meeting will be.

According to The Guardian, a respectable British newspaper, lawsuits over Avandia may may be in the range of billions of dollars (based on UBS research which estimates that 13,000 suits have been filed).

Dr. Murray Stewart, Vice President for Clinical Development at GSK, was quoted in a July 9th company press release as saying:

“Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia and together they show that this medicine does not increase the overall risk of heart attack, stroke or death. We also know that Avandia lowers glucose levels in both the short- and long-term and is the only oral anti-diabetic medicine that has been shown to sustain blood sugar control for up to five years.[1] We look forward to presenting these data and participating in a rigorous scientific discussion with the advisory committees.”

Yesterday (Friday), the European Medicines Agency (EMEA) announced that its Committee for Medicinal Products for Human Use is going to discuss the safety of Avandia at its July 19-22 meeting and will issue an opinion on whether Avandia and other medications with its active ingredient should be suspended, changed or revoked.

In a press release, the EMEA wrote:

” The European Medicines Agency has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, to determine whether new data on the risk of cardiovascular problems have an impact on their benefit-risk profile. The review by the Agency’s Committee for Medicinal Products for Human Use (CHMP) follows the recent publication of further studies on the cardiovascular safety of rosiglitazone.”

Source: EMEA, FDA, GSK

Written by Christian Nordqvist