FDA Moves To Take Drug For Low Blood Pressure Off The Market : Shots - Health News In a first, the agency is proposing to withdraw approval for a medicine because its maker didn't follow through on a promise to conduct clinical tests. The drug was prescribed to about 100,000 people in 2009.
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FDA Moves To Take Drug For Low Blood Pressure Off The Market

Well, what do you know. Only this morning we were writing about how rarely the Food and Drug Administration takes a drug off the market because a company hasn't followed through on promised studies, or because those tests didn't turn out well.

And this afternoon the agency says it's going to press forward with legal action to revoke approval of ProAmatine, a drug for people with low blood pressure. It's the first time the agency and taken this step.

We're not taking credit. But we do find it interesting that the agency appears to be on a cleaning jag when it comes to post-market studies that were company's IOUs for approval.

The medicine, also sold generically as midodrine, is prescribed for people who tend to faint when they're upright.

The FDA fast-tracked approval of ProAmantine in 1996, on the condition that the drugmaker do more clinical tests to show that the medicine had a real clinical benefit.

We e-mailed and called Shire, maker of ProAmantine, for comment but haven't heard back so far.

"To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities," the agency said in a statement.

Shire has 15 days to let FDA know whether it wants a formal hearing.

FDA figures about 100,000 people in the United States had prescriptions filled for the medicine last year.

Update: Shire said in a e-mail to us that it is "currently reviewing" FDA's proposal. The company said it "did conduct and complete the trials that the FDA required; the FDA viewed these trials as inconclusive."

Shire told the agency and doctors "earlier this year that it is withdrawing" ProAmatine and has offered to assist the makers of the generic versions "by providing them full access to Shire's data" if the companies want to conduct the studies FDA wants.