|Published:||Sep 06, 2010 6:31 PM EDT|
|Updated:||Sep 06, 2010 3:28 PM EDT|
NEW YORK (AP) - Federal regulators are reversing a plan to remove a low blood-pressure treatment from the market after warning in August that it had not been proven effective.
A Food and Drug Administration representative says the agency will continue to allow access to ProAmatine, also known as midodrine, "while the necessary data is collected and the legal issues get sorted out."
Roughly 100,000 U.S. patients received prescriptions for ProAmatine or generic versions last year. The drug is approved to treat orthostatic hypotension, a type of low blood pressure that causes patients to become dizzy or faint when standing upright.
The FDA proposed withdrawing the drug and giving its maker Shire PLC, which is based in Ireland, an opportunity to discuss the matter.