SILVER SPRING, Md., Aug. 16 /PRNewswire-USNewswire/ — The U.S.
Food and Drug Administration today proposed to withdraw approval of
the drug midodrine hydrochloride, used to treat the low blood
pressure condition orthostatic hypotension, because required
post-approval studies that verify the clinical benefit of the drug
have not been done.
Patients who currently take this medication should not stop
taking it and should consult their health care professional about
other treatment options.
The drug, marketed as ProAmatine by Shire Development Inc. and
as a generic by others, was approved in 1996 under the FDA’s
accelerated approval regulations for drugs that treat serious or
life-threatening diseases. That approval required that the
manufacturer verify clinical benefit to patients through
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.
Orthostatic hypotension is a condition in which patients are
unable to maintain blood pressure in the upright position and,
therefore, become dizzy or faint when they stand up.
“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.”
The FDA today issued a Proposal to Withdraw Marketing