FDA Recommends Withdrawal of Midodrine


August 16, 2010

August 16, 2010 (Silver Spring, Maryland) The US Food and Drug Administration (FDA) is recommending the withdrawal of midodrine hydrochloride, currently used in the treatment of low blood pressure, because there are insufficient data to support its benefit [1].

The necessary postmarketing studies needed to show the drug is effective have not been done, according to the agency. As a result, the FDA is proposing the drug be withdrawn from the market.

"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 Division of Cardiovascular and Renal Drugs at the Center for Drug Evaluation and Research, stated in a press release issued by the agency. "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."

Midodrine is manufactured by Shire Development Inc, as well as by generic drug companies, and was approved in 1996 under a regulation that allowed accelerated approval for drugs to treat serious or life-threatening diseases. A condition of the approval, however, was that Shire, the maker of the brand-name drug (ProAmatine), prove the clinical benefit in postapproval studies. So far, neither Shire nor the generic companies have shown that the drug has any clinical benefit, such as improving the ability to perform daily activities.

This is the first time the FDA has issued a proposal to withdraw a drug approved under the accelerated approval regulations. Shire has 15 days to request a hearing from the FDA, and makers of generic versions of the drug have 30 days to submit written comments about the FDA's proposal. A final decision about whether or not to withdraw the drug will be made after the submissions from Shire and the generic drug makers are considered.