The drug, called midodrine hydrochloride or ProAmatine, was approved by federal regulators on an accelerated basis in 1996 because it was seen as a treatment for “serious or life-threatening diseases.”
A caveat of fast-track approval was that both the original and generic manufacturers would conduct additional clinical trials to verify the drug’s clinical benefit. The FDA maintains those additional tests on humans have not been done by the drug’s original or generic manufacturers. The drug is marketed by Shire Development Inc., and as a generic by Apotex Corp., Impax Laboratories, Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith.
The drug is intended to treat orthostatic hypotension, a condition in which patients are unable to maintain blood pressure while in an upright position, leading to dizziness and fainting.
Last year, about 100,000 people in the United States filled prescriptions for the drug, according to the FDA.
“We’ve worked continuously with the drug companies to obtain additional data showing the drug’s clinical benefits to patients,” Dr. Norman Stockbridge, director of the FDA’s Cardiovascular and Renal Drugs division, said. “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.”
This is the first time the FDA has asked for a drug to be removed from the market for failure to conduct the required follow-up study. Last year, the Government Accountability Office cited ProAmatine as an example of FDA’s failure to track certain drugs after launch.