The Food and Drug Administration has decided to propose the removal of a low-blood-pressure drug from the market which is made by several drug companies, including Maple Grove-based Upsher-Smith Laboratories.

The drug in question here is called midodrine hydrochloride or ProAmatine and was approved by federal regulators on a very quick basis in 1996 due to the fact that it was seen as a treatment for “serious or life-threatening diseases.”

The reason of accelerated approval was that both the original and generic manufacturers would conduct additional clinical trials to confirm the clinical benefits of the drug. The FDA now says that those additional tests on humans were not carried out by the drug’s original or generic manufacturers.

The target area of the drug is the treatment of orthostatic hypotension which is a condition in which patients are unable to maintain blood pressure in an upright position which leads to dizziness and fainting.

Dr Norman Stockbridge, director of the FDA’s Cardiovascular and Renal Drugs division said, “We've worked continuously with the drug companies to obtain additional data showing the drug's clinical benefits to patients. 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.”