FDA Proposes Blood Pressure Drug Withdrawal From U.S. Market

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FDA Proposes Blood Pressure Drug Withdrawal From U.S. Market

Postby jimithy » Mon Aug 16, 2010 7:49 pm

ProAmatine by Shire Development Inc. and the generic drug, Midodrine hydrochloride have been on the U.S. market fraudulently for years. The required clinical studies were never done by the company even though they agreed to do so. This is true of a great many medications but it appears that the FDA is FINALLY taking steps to remove a drug that has been sold in the U.S. for 14 years.

Midodrine hydrochloride: FDA Proposes Low Blood Pressure Drug -
[Posted 08/16/2010]
AUDIENCE: Cardiology and Nephrology
ISSUE: FDA proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition, orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.
BACKGROUND: The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.
RECOMMENDATION: Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.

[08/16/2010- News Release - FDA]
http://www.fda.gov/Safety/MedWatch/Safe ... 222640.htm
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