FDA Meeting in June May Lead to Avandia Recall, Expert Says

Some observers say that an upcoming FDA advisory panel meeting scheduled to re-examine the side effects of Avandia, may actually result in a recall for the heavily restricted diabetes drug.  

According to a report published by Heartwire, a medical expert said that the joint meeting of two FDA advisory panels in early June will likely close the book on Avandia.

GlaxoSmithKline’s once-blockbuster diabetes drug was severely restricted by the FDA in 2010, due to an increased risk of heart attack.

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Although many critics called for Avandia to be recalled at that time, the FDA allowed it to remain on the market with strict limitations on availability.

Earlier this month, the FDA announced that a joint meeting of the agency’s Endocrinologic and Metaboloc Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee will be held on June 5 and 6. The meeting will take a second look at the results of a clinical trial, which found little risk of heart attack with Avandia use.

The clinical trial, the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD), posted results that contradicted some other studies that suggested high rates of heart attacks linked to Avandia use.

Experts say the re-evaluation of RECORD’s results is likely to show more Avandia heart attacks and give the FDA the impetus to finally recall the drug, which now only has about 3,300 users due to restrictions placed on who can receive the medication and concerns about the risk of heart attacks.

An Avandia recall has already been issued in Europe and a number of other countries worldwide. A number of groups and experts in the U.S. have called on the FDA to do the same.

The original study that raised the concern about the link between Avandia and heart attacks was led by Dr. Steven Nissen, of the Cleveland Clinic in 2007. However, that was followed by RECORD, which was conducted by researchers at Duke University. RECORD determined that there was no increased risk of heart attack linked with Avandia. However, in 2010, FDA experts called RECORD flawed and determined that it likely undercounted the number of Avandia heart attacks.

Avandia (rosiglitazone) was a popular type 2 diabetes drug that was used by millions of people before it was linked to an increased risk of heart attacks and heart problems. Some reports have suggested that as many as 100,000 heart attacks may have been caused by Avandia.

GlaxoSmithKline has reportedly agreed to pay more than $1 billion to settle Avandia heart attack lawsuits brought by former users of the medication who allege that the drug maker provided inadequate warnings to consumers and the medical community.


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