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Consumer Reports Slams FDA for Keeping Avandia on the Market

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(CBS) Consumer Reports today slammed the FDA's decision to allow the risky diabetes drug Avandia to remain on the market.

The agency "falls short of its counterpart across the ocean, the European Medicines Agency, which decided Avandia was too risky" to remain available, a Consumer Reports editor wrote in a blog post.

Instead of banning the drug, the agency said it would significantly restrict the use of Avandia to patients with Type 2 diabetes who cannot control their diabetes on other medications.

The restriction is in response to data linking the drug to heart attack and stroke.

"The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks," FDA Commissioner Dr. Margaret A. Hamburg said in a written statement. "We are seeking to strike the right balance to support clinical care."

Hamburg's colleague, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluaton and Research, said in a written statement, "Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug."

But Consumer Reports wasn't buying that line.

Dr. John Santa, director of the Consumer Reports health ratings center, said in a prepared statement that he worried that doctors and patients would continue to be exposed to a risky drug - without being fully alerted to those risks. "The evidence we have to date does not support the use of Avandia as a first, second, or even third line drug for treating type 2 diabetes. This latest effort on the part of the FDA to deal with a drug that's unsafe will only confuse consumers."

He said safer diabetes drugs were available, including metformin.


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