Midodrine Removed: Hypotension Drug Removal

Philadelphia-based Shire, the pharmaceutical company, has voluntarily removed its orthostatic hypertension drug Midodrine, just after the FDA announced it’s intention to withdraw it’s approval for the drug.

Last November, Shire spoke to the FDA and told them they would be pulling the plug on the drug rather than conduct post-market studies, which were requested by the FDA.

ProAmatine is what the drug is sold to consumers as, will be withdrawn from shelves, effective on the 30th of September, according to a statement released on the company’s website.

The drugs efficacy was never proved to the FDA from post-marketing studies, and there was no evidence available to show that the drug was working. This is the reason why the FDA was withdrawing it’s approval.

This is the first time marketing approval has been reversed since the FDA’s fast track system was put in place.

What happens during the fast track process, is the drug is released on to the market, and studies are done while the drug is being used by patients and suffers, called post-market studies. These are hoped to show the quality and effectiveness of the drug while available to the general population. A decision is then made based on these studies as to whether or not the drug will be allowed to keep it’s approval or will be withdrawn. This fast tracks the process of getting much needed drugs and pharmaceuticals into wide spread use, to ease the pain of suffers.

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