Midrodine Recall Paused While FDA Reviews Drug Data

Federal drug safety reviewers are backing off threats to force a recall of midrodine, which is marketed as ProAmantine, indicating that they will give the manufacturers of the low blood pressure drug time to collect required data and iron out legal issues necessary to establish that it should continue to remain on the market. 

The FDA proposed last month to remove drug approval for ProAmatine and its generics after finding that Shire Development, Inc. had failed to show that the drug provided clinical benefits to users. However, according to a report by The New York Times, officials are now saying that they will not force the drug off of the market after being flooded by complaints from patients who take the medication.

ProAmantine (midodrine hydrochloride) was approved by FDA in 1996 for the treatment of the low blood pressure condition called orthostatic hypotension. It was approved under an accelerated process reserved for drugs that are needed to save lives. Under the terms of the approval, the manufacturers had to conduct post-market studies to show that the drug provided a clinical benefit to patients. At the time of its approval, all it needed to show FDA was a surrogate endpoint believed to be a predictor of actual clinical benefits, which in this case was increased blood pressure.

After 14 years, neither Shire nor the manufacturers of generic midodrine hydrochloride have provided proof that the drug actually helps individuals live longer or more comfortably, the FDA claims. The generic manufacturers include Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories.

At first, Shire officials said they would not contest the market withdrawal, since generic versions of the drug have eviscerated sales. There are about 100,000 patients taking the drug, and Shire only controls 1% of that market. However, late last week the company changed its stance, saying that there was evidence that the drug works.