The Food and Drug Administration (FDA) is preparing to tackle a review of the drug, Avandia, but meanwhile, European regulators are launching their own look into the safety of the GlaxoSmithKline Plc’s (GSK) diabetes pill. That is not good news for Avandia which was at one time Glaxo’s second-best selling drug.
According to a Reuters article, sales have plunged over the last three years since the controversy over its link to an increased risk of stroke and cardiovascular problems have surfaced.
Prompted by new studies, the European Medicines Agency (EMA) will review the risks and benefits of the drug. At a committee meeting, July 19, the EMA will decide whether to remove Avandia from the market, suspend sales, or review its approval.
“The EU reviewing the dossier is somewhat of a surprise,” Royal Bank of Scotland analyst Michael Leacock tells Bloomberg.
GSK officials have vigorously defended the drug calling it “an important treatment option for appropriate Type 2 diabetes patients.”
“Since 2007, we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia,” VP Murray Stewart tells the Philadelphia Inquirer, “and together they show that this medicine does not increase the overall risk of heart attack, stroke or death.”
An FDA staff review of the drug, posted in preparation for Tuesday’s advisory meeting, finds there are problems with the handling of the clinical trial. Called RECORD, critics say the RECORD trial was too short in length and the underlying data was misinterpreted.
Drug makers, doctors, attorneys, and medical malpractice plaintiffs are watching the result of the Tuesday meeting as shares for GSK fell upon the news of the two inquiries on Friday, July 9.
