FDA Returns Midodrine To Market for Orthostatic Intolerance

Just two weeks ago, the FDA had announced that they would be taking the drug midodrine off the market but now they have backtracked and decided to continue marketing the drug for orthostatic intolerance.  The FDA originally stated they were pulling the drug because the drug maker’s had never confirmed that the medication helped allieviate the symptoms of orthostatic intolerance, which include dizziness and fainting for some people.

Apparently, many of the 100,000 patients that use midodrine complained heavily to the FDA so they decided to leave the drug on the market.  According to the New York Times article:

In a different situation, we might act differently,” said Dr. Joshua Sharfstein, principal deputy commissioner. “But in this case, it does not make sense to pull access to the drug while we get better data.”

Dr. Janet Woodcock, director of the agency’s drug center agreed. “Patients are out there thinking doom is about to fall, and they can’t go about their normal business,” she said. 

The agency’s flip-flop demonstrates the difficult choices regulators face in policing the nation’s drug market. Cracking down on drug makers sometimes means stranding desperate patients. And now that Congress has given the Food and Drug Administration greater powers to insist on better information about life-saving medicines, such disputes may become more common.

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