FDA alert issued for nimodipine

February 6, 2006

A reminder that nimodipine (Nimotop, Bayer) capsules should be taken orally only has been issued by the FDA following reports of several cases of parenteral administration resulting in death. Because a syringe is sometimes used to extract the gel inside the capsule for patients who cannot swallow the pill form, the drug was inadvertently given intravenously. The FDA recommends healthcare providers label the syringe "for oral use only" to avoid confusion and has asked the manufacturer to add a boxed warning to nimodipine's labeling describing the life-threatening risk. In addition, the agency has requested that Bayer develop an oral solution of the drug for patients who are unable to swallow the capsule. When nimodipine is given intravenously instead of orally, the effect can be much stronger, leading to cardiovascular collapse and possibly death. The agency said there have been additional reports of nonfatal parenteral administration.