• 27
  • September
    2010

In their decision last Thursday, the Federal Drug Administration (FDA) acknowledged what many former patients and their families already knew - the diabetes medication Avandia is a dangerous drug. Linked by several studies to an increase in the risk of heart attack, the drug was recently banned in Europe. Still, FDA officials were slow to give a definitive answer and, in many ways, Thursday's decision kept the issue cloudy.

In short, Avandia was not recalled or withdrawn from the market. Instead, the FDA made it a lot harder for consumers to attain the drug and added layer upon layer of warning and restriction.

In The New York Times, Gardiner Harris reports that the decision to keep Avandia on the market was far from unanimous. Many of the FDA's top scientists questioned the decision and many of those familiar with the administration wondered aloud what drug regulations would look like in the future.

One thing is for certain, they will like as not be black and white. Whereas past decisions have dealt more in maxims and less in qualifiers, new regulatory decisions could come in a number of flavors.

As Harris points out in the Times article, this isn't a system that is really sustainable. In Avandia's case, patients will only be allowed to take Avandia if both they and their treating physician can attest to the fact that they have tried every other diabetes drug available. Patients will also be apprised of the risk posed by taking the drug.

This will be confusing enough with one drug, but what if the FDA decides to apply this type of system to other products?

At least in Avandia's case, the drug will be harder to obtain, though the danger posed by the medication is far from removed.

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