Posted: 04-21-10 Categories:
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FDA may suspend Avandia safety study, could lead to Avandia recall

An Avandia safety study called the TIDE trial may be suspended by the FDA over Avandia heart attack risks.

Calls for an Avandia recall have been renewed over concerns that the diabetes drug increases heart risks. In February, a critical Senate report on Avandia was released following a two-year Senate Finance Committee investigation. Internal FDA documents were made public, including a 2008 memo from two FDA drug safety reviewers recommending an Avandia recall.

An Avandia safety study known as the TIDE trial was approved by the FDA in 2007 to compare the popular diabetes drug with a competing drug called Actos. Several researchers have criticized the study, pointing out that it is unethical to compare a drug with known cardiovascular risks with a safer drug. They call for an Avandia recall for the same reason.

It has been reported that FDA Commissioner Margaret Hamburg wrote a letter to ranking Senate Finance Committee Republican Chuck Grassley, co-author of the Senate Avandia report, stating that the FDA is reconsidering the TIDE trial.

FDA Principal Deputy Commissioner Joshua Sharfstein has been quoted as saying that while the FDA hasn’t yet made a decision about TIDE trial, the FDA’s decision on the TIDE trial, “cannot be de-linked from the agency’s view of Avandia.”

The FDA has asked a government scientific panel to review the ethics of head-to-head trials. Sharfstein said no decision had been made on the TIDE trial.

In late March, Saudi Arabia’s Food and Drug Authority suspended Avandia for six months upon concluding that the potential heart risks of Avandia outweigh its benefits. It was the first prescription drug regulator to pull Avandia from the market.

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