Posicor®

Roche Laboratories of Nutley, NJ has announced that it is voluntarily withdrawing the heart drug, Posicor® (mibefradil), from the market as a result of new information about potentially harmful interactions with other drugs.

When Posicor® entered the market in August of 1997, its enzyme-inhibiting properties were described in the labeling. The labeling specifically listed three drugs (astemizole, cisapride, and terfenadine) that could be expected to accumulate to dangerous levels if Posicor® was coadministered.

In December, after learning of several cases in which patients suffered serious adverse reactions after taking Posicor® with one or more of the other drugs, FDA strengthened the labeling of Posicor®, and two more drugs (lovastatin and simvastatin) were added to the label's list of those that should never be coadministered with Posicor®. FDA also issued a public warning about this problem and the company issued a Dear Doctor letter to physicians.

From spontaneous reports and ongoing trials, FDA and Roche continued to learn of adverse reactions related to coadministration of Posicor® with several other drugs. At present, more than 25 drugs are known to be potentially dangerous if used with Posicor® - a number and diversity of drugs that cannot be practically addressed by standard label warnings.

Since Posicor® has not been shown to offer special benefits (such as treating patients who do not respond to other antihypertensive and anti-anginal drugs), the drug's problems are viewed as an unreasonable risk to consumers.

Source: fda.gov

If you or a loved one has been harmed by Posicor®, you may want to contact a Posicor® attorney for more information.