Black Box for Avandia?

The diabetes drug will carry the stiffest possible warning if regulators have their way.

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Oh, great. It turns out that the Food and Drug Administration was far more concerned than it has publicly let on about the heart risks posed by the diabetes drug Avandia. And not just Avandia but Actos, the only other medication on the market that works the way Avandia does to control blood sugar for people with type 2 diabetes.

A third of the way into a 17-page statement Andrew von Eschenbach read aloud yesterday at House hearings on Avandia (covered in my previous blog), the FDA commissioner revealed that on May 23, just two days after a major study published online by the New England Journal of Medicine showed a sharply increased rate of heart attacks and heart failure among Avandia patients, the agency officially requested a "black box" warning for both drugs. This means that GlaxoSmithKline and Takeda, manufacturers of Avandia and Actos, respectively, would add language in a box on the product label calling attention to a particular risk. For these two drugs, the warning would highlight an increased risk of congestive heart failure.

You don't want to prescribe a medication that raises the chance of heart failure to someone who already has been diagnosed with the condition. But the FDA has concluded that although the "warnings" sections of the current product labels include language describing the higher risk, some doctors are prescribing the drugs to just such patients.

There's more. A few days after making the request, the FDA assembled a group of healthcare providers, patients, and others to figure out how to get across to the public that while the conclusions reached by the authors of the New England Journal article were alarming, they weren't necessarily final. Much more study remained to be done. This "stakeholder meeting," as the FDA calls it, also was not made public.

The final indication of the FDA's now official worry was von Eschenbach's announcement of a public meeting of an advisory committee to assess Avandia's pros and cons. In light of the information now on the record, the meeting, scheduled for July 30, will very probably determine the drug's fate. It could remain on the market, with additional and stronger warnings--or the meeting could be a prelude to a recall.

Many people with type 2 diabetes are helped by this drug. If you are the kind of patient for whom Avandia is intended, and as long as your physician is alert for possible problems, this is not the time, regardless of scary statistics, to quit. The advice from experts is still: Talk with your doctor. Taking no drug at all is truly risky.