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Should ProAmatine (midodrine) Be Available?

Tuesday, September 07, 2010

Should ProAmatine (midodrine) Be Available?

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I had never heard of midodrine, a treatment for orthostatic hypotension, until I read: FDA relents from midodrine withdrawal plan. Once again, one must question the value of a watch-dog that barks, but never bites.  . . . 

right arrow image   Read More  Should ProAmatine (midodrine) Be Available?

Midodrine, marketed under the brand name ProAmatine, is prescribed for patients with low blood pressure who become dizzy or faint when they stand up. It was approved in 1996, based on initial treatment results, with the caveat from the FDA that a follow-up study would be conducted to actually prove that there were long-term benefits. That study, it seems, was never done.

Now, I realize that the FDA can't be everywhere. But this oops didn't require physically visiting a manufacturer. It simply involved finding and using a viable method for follow-up. We used to call them 'tickler files' and, rather than rely on memory, would put a note or other reminder into the appropriate month/year folder.

On a monthly basis, the notes in the applicable folder would be reviewed for necessary action. It's manual - stone-knives-and-bear-skins, as we used to say - but at least things were looked at. Unlike the midodrine situation, which was able to fly under the radar for 14 years.

If that weren't bad enough, after the FDA determined that 1.) the study was not conducted as required, 2.) the medication, therefore, had not been proven effective, and 3.) the drug should be pulled from the market, pending completion of the mandatory study - they caved. Note to drug makers: "Okay, you 1.) didn't do the work, 2.) told your Mom you passed, anyway, and 3.) we really need to flunk you. But, hey, we'll go ahead and let you perform surgery. Just try to finish your training before you kill someone."

Just when I thought the FDA might be getting a clue.


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