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FDA backs off ProAmatine removal


A potentially ineffective drug used to treat low blood-pressure will remain on the market after US federal regulators postponed plans to remove it.

Sandy Walsh, Food and Drug Administration (FDA) representative, said that “while the necessary data is collected and the legal issues get sorted out ” access to the drug ProAmatine, also called midodrine, will continue to be allowed.

The Shire PLC low blood-pressure drug treats orthostatic hypotension, which leads to sufferers becoming dizzy or even fainting when they stand upright.

Last month, the FDA proposed withdrawing the drug from the market and giving Shire, which is based in Ireland, an opportunity to schedule a hearing to discuss the matter. It had approved ProAmatine in 1996 based on promising early results in treating low blood pressure. But a mandatory follow-up study to actually prove the long-term benefits of the drug was never conducted.

Shire acquired the drug when it bought Roberts Pharmaceuticals in 2000. Shire spokeswoman Jessica Mann said the drugmaker did conduct follow-up trials and submitted data in 2005 that it believes showed its effectiveness. The company plans to continue to work with the FDA.

Copyright Press Association 2010


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