The US Food and Drug Administration proposed today to withdraw approval of midodrine hydrochloride, marketed as ProAmatine by Shire Development Inc, because post-approval studies that are required to verify the clinical benefit of the drug have not been done. The FDA is encouraging patients who are taking this medication to consult their health care professional about other treatment options.
Midodrine hydrochloride is used to treat orthostatic hypotension, a condition of low blood pressure brought on by a sudden change in body position – usually when shifting from lying down to standing. It can be caused by many different conditions, such as dehydration, heart problems, diabetes, or nervous system disorders, including Parkinson’s disease.
Years ago FDA accelerated ProAmatine blood pressure drug approval
The drug was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. According to the FDA, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit.
"We've worked continuously with the drug companies to obtain additional data showing the drug's clinical benefits to patients," said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research. "Since the companies have not been able to provide evidence to confirm the drug's benefit, the FDA is pursuing a withdrawal of the product."
Shire must respond to the FDA in writing within 15 days to request a hearing. Sponsors of the generic versions, including Apotex Corp, Impax Laboratories, Mylan Pharmaceuticals, Sandoz Inc, and Upsher-Smith Laboratories will have 30 days to submit written comments on the notice.
According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009.