Despite GlaxoSmithKline saying it does not plan to make almost-discontinued diabetes drug Avandia available in the USA, the FDA’s Endocrinologic and Metabolic advisory panel along with the FDA’s Drug Safety and Risk Management Advisory committee will consider the medication’s safety in June 2013.

In September 2010, the FDA (Food and Drug Administration) severely restricted Avandia usage, and ordered GlaxoSmithKline to convene an independent group of scientists to re-check data on the drug’s clinical trials., because of its association with a higher risk of serious cardiovascular diseases, including congestive heart failure, heart attack and premature death The Agency at the time said Avandia should only be prescribed for patients who are unable to control their diabetes with any other medication.

Avandia (rosiglitazone) was taken off the market in Europe in 2010.

Mary Anne Rhyne, a GSK (GlaxoSmithKline) spokeswoman said that the FDA advisory panel plans to meet on June 5th and 6th to discuss Avandia, according to the next edition of the Federal Register. It is likely that GSK will be asked for safety update information, which was originally requested in 2010.

The 2010 FDA Panel had requested that GSK commission a re-examination of a large Avandia clinical trial, known as RECORD, in order to get a better idea of its safety. The Panel also asked GSK for a Risk Evaluation and Mitigation Strategy plan, i.e. a way of better controlling the availability and usage of the medication.

GSK informs that it had not requested any label or distribution changes for Avandia, neither had it asked for the planned June meeting.

According to Rhyne, a team from Duke University has re-examined the RECORD trial and submitted their findings to the FDA. Cardiovascular safety between Avandia and two other commonly used oral medications – metformin and sulfonylureas – was “not significantly different”, Rhyne added.

Avandia 2mg oral tablet
Avandia 2mg oral tablets – linked to serious cardiovascular diseases and early death risk

Since 2004, several studies by researchers and regulatory authorities have been carried out on Avandia, with mixed results.

Written by Christian Nordqvist