Safety Alerts & Recalls

What does this mean?

At this time, midodrine continues to be available by prescription. The FDA has given the manufacturers time to request a hearing and submit written comments about the withdrawal of midodrine. The FDA will then review the submissions and make a final decision about the withdrawal of midodrine products from the market.

If you currently take midodrine or the brand ProAmantine, you should continue taking your medicine. Since this medicine may be withdrawn from the market in the near future, you should also follow up with your doctor or other health care professional to discuss the other treatment options available for your condition.

Companies Failed To Prove Benefits of Midodrine (ProAmantine)

The U.S. Food and Drug Administration (FDA) has proposed to withdraw the approval of the low-blood pressure medicine midodrine (ProAmantine) because required post-marketing studies on the drug's effectiveness have not been done. Midodrine was approved under the FDA's accelerated approval program for drugs that treat serious or life-threatening diseases. This program requires that the manufacturer verify benefits to patients through post-marketing studies.

Midodrine is used to treat the low blood pressure condition called orthostatic hypotension. Midodrine is marketed as ProAmatine by Shire Development Inc. and generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories.

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Source: FDA
Publication Date: 2010-08-17
Last Updated: 2010-08-17

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