According to the Food and Drug Administration (FDA), the popular blood pressure drug, ProAmatine, may be pulled off of shelves in the coming months.

ProAmatine (midodrine hydrochloride) is manufactured by Shire PLC for the treatment of low blood pressure (hypotension).  The drug was approved in 1996 by the FDA, following initial positive clinical trial results.  This medication is only available with a prescription, and works by stimulating nerve endings in blood vessels, causing the blood vessels to tighten. As a result, blood pressure is increased.  In addition to its primary use as a medication to treat hypotension in adults, ProAmatine has also been used to treat hypotension in children with an infection and to treat hypotension caused by kidney dialysis.  Side effects of ProAmatine include anxiety, blurred vision, headache, pounding in the ears, and urinary frequency, retention or urgency.

Shire PLC states that it will pull ProAmatine off the market beginning on September 30, 2010, following warnings from the FDA who said the drug has not been proven effective.  ProAmatine was approved due to the FDA’s accelerated approval system, which approves a drug more rapidly, but requires proof of additional trial results after approval.  According to Shire PLC, “the studies required by the FDA were completed, but viewed as inconclusive.”

According to the FDA, roughly 100,000 U.S. patients received prescriptions for ProAmatine or generic versions in 2009.