Shire to pull blood-pressure drug from market

If you use ProAmatine for blood pressure, Shire is taking it off the market.


The AP (8/18, Perrone) reports, “Shire PLC said Tuesday it will pull” its blood-pressure drug ProAmatine (midodrine hydrochloride) “off the market” by the end of September “following warnings from federal regulators who said the drug has not been proven effective.” The FDA said earlier this week that “Shire never established the long-term benefits of the drug, as required under the agency’s so-called accelerated approval system.” Shire “said in a statement it completed the studies required by the FDA, but the agency ‘viewed these trials as inconclusive.’ The company also said it notified the FDA and physicians last year that it would pull the drug from the market effective Sept. 30.”
The Wall Street Journal (8/18, Stovall) notes that Shire also said the drug is not profitable enough to justify additional clinical tests required by the FDA.