UPDATE September 30, 2010: Now it turns out the FDA will not be pulling ProAmatine from the market.
Food and Drug Administration representative Sandy Walsh said in an emailed statement that 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."
Used in the treatment of postural related hypotension, the FDA in August originally said 14 years was long enough for ProAmatine to remain on the market without any proof that it works. Here is a copy of Shire's open letter to patient regarding their efforts to comply with FDA requirements. I guess they changed their minds. Maybe they got a federal stimulus funds grant to study the issue. Or more likely some Senator's grandmother uses it and they brought down the hammer on the FDA.
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Food and Drug Administration representative Sandy Walsh said in an emailed statement that 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."
Used in the treatment of postural related hypotension, the FDA in August originally said 14 years was long enough for ProAmatine to remain on the market without any proof that it works. Here is a copy of Shire's open letter to patient regarding their efforts to comply with FDA requirements. I guess they changed their minds. Maybe they got a federal stimulus funds grant to study the issue. Or more likely some Senator's grandmother uses it and they brought down the hammer on the FDA.
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Any hospitalist who takes care of dialysis patients or old people knows that ProAmatine (midodrine) is one of the most common medications used to treat orthostatic hypotension (a positional drop in blood pressure). It now appears the FDA might pull ProAmatine from the market due to failure of proven efficacy.
According to the FDA news release:
The U.S. Food and Drug Administration today 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.
Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.
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.
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.
1996? The drug has been on the market for 14 years without proven efficacy? I just have one question: Why now? It has been 14 years. Why would the FDA care now? Why didn't they care after five years? Why didn't they care after ten years? Heck, the drug is so old it has even gone generic. Why would any company fund a study now? Call me a conspiracy theorist, but I suspect hidden in this decision might be an ulterior motive. Perhaps another drug company has filed an application for a new medication to treat orthostatic hypotension and they are looking to squash the competition. That wouldn't surprise me one bit considering senior SEC staffers are surfing porn eight hours a day and the major public news outlets are no where to be found.
