The FDA is proposing 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.
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, according to the agency.
The drug, marketed as ProAmatine by Shire Development and as a generic by other pharmaceutical companies, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. However, the agency noted that the approval required that the manufacturer verify clinical benefit to patients through post-approval studies.
The FDA said that patients who currently take this medication should not stop taking it and should consult their healthcare professional about other treatment options.