Hypotension drug faces withdrawal

The FDA proposed to withdraw approval of midodrine hydrochloride (ProAmatine), a drug used to treat orthostatic hypotension, because required post-approval studies to verify the clinical benefit of the medication have not been done.

Patients who currently take this medication should not stop taking it but should consult their health care professional about other treatment options, advised the FDA announcement. The agency is working with the drug's manufacturers to develop an expanded-access program to allow patients who currently receive the drug (which is produced under its brand name and as a generic) to continue to receive it. This is the first time the FDA has issued such a notice for a drug approved under its accelerated approval regulations.