The maker of blood pressure medication ProAmatine will remove the drug from the market, after the U.S. Food and Drug Administration (FDA) threatened to recall the drug because of lack of proof concerning the drug’s long-term benefits. The FDA stated that the maker failed to conduct postmarketing clinical trials to confirm the drug’s effectiveness.
ProAmatine—which received accelerated approval in 1996—and its generic versions are used by approximately 100,000 Americans to treat a type of low blood pressure that can cause dizziness and fainting when standing upright. The drug maker, Shire PLC, never proved the long-term benefits of the drug as required, according to the FDA. A Shire representative says that the drug is not profitable enough to justify additional clinical trials.
For the full story, go to the Wall Street Journal.