Avandia Safety Being Reconsidered By FDA Panel

Date: Apr-15-2013Despite 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 tablets - linked to serious cardiovascular diseases and early death risk
Avandia, a mixed history of studies
Since 2004, several studies by researchers and regulatory authorities have been carried out on Avandia, with mixed results.
September 2004 - 60% Of Type 2 Diabetes Patients Reach Glucose Targets with Avandia Plus Metformin Combo
September 2006 - Avandia Reduced Risk Of Progression From Pre-Diabetes To Type 2 Diabetes By 62%
December 2006 - Landmark Study Shows Avandia Is More Effective Than Metformin Or A Sulfonylurea In Long-Term Blood Sugar Control
May 2007 - Avandia Heart Attack Risk 'not Cause For Alarm', says Diabetes UK
May 2007 - US FDA Issues Safety Alert On Avandia
May 2007 - European Medicine's Agency Statement On Recent Publication On Cardiac Safety Of Avandia
May 2007 - GSK Affirms Avandia Cardiovascular Safety Profile
July 2007 - German Researchers Find More Reasons To Avoid Diabetes Drug Avandia
July 2007 - FDA Advisory Panel Votes 22 To 1 For Avandia To Remain Available To US Patients
November 2007 - Ban For Avandia In USA, But A Warning About Increased Heart Risk
January 2008 - GSK To Revise Avandia Label In Europe Following Assessment By CHMP
June 2009 - Avandia Has No Increased Overall Cardiovascular Risk Compared To Other Commonly Used Diabetes Medicines, Large, Long-Term Study Shows
February 2010 - American Heart Association Statement On Avandia Following Senate Report On Avandia
June 2010 - As FDA Prepares To Debate Avandia's Safety, 2 New Studies Add To Evidence Of Risks
July 2010 - Keep Avandia On The Market, Advises Federal Advisory Panel, With Reservations
September 2010 - FDA Keeps Avandia On The Market With Restrictions
September 2010 - European Medicines Agency Recommends Suspension Of Avandia
September 2010 - Concern About Avandia And How Medications Are Regulated And Promoted, BMJ
July 2011 - Avandia Might Help Prevent Neuropathic Pain
Written by Christian Nordqvist

View drug information on Avandia.

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