Manufacturer to Withdraw ProAmatine Effective September 30, 2010

August 26, 2010 9:42 am

Shire, the manufacturer of ProAmatine (midodrine hydrochloride), a drug used to treat orthostatic hypotension, has announced that it will voluntarily withdraw ProAmatine effective September 30, 2010. In a Web site announcement, the manufacturer states that FDA was notified in November 2009 of the company’s intentions to withdraw the product and that its decision followed FDA’s determination that additional post-marketing trials were required as FDA viewed previous trials as inconclusive. The company notes that the withdrawal was not due to safety concerns.

Shire’s announcement comes in response to FDA’s notice of proposed withdrawal of the product which was announced on August 16, 2010. Several other manufacturers produce generic versions of midodrine hydrochloride and sponsors of generic midodrine have 30 days to submit written comments on the notice to FDA. More information is available in an FDA News Release.

FDA advises that patients who currently use the drug should continue taking it until they consult their health care provider regarding alternative treatment options. Further, FDA is working with the manufacturers to develop an expanded-access program to assist patients who are currently being treated with midodrine. More information about expanded-access programs is available on the FDA Web site.