FDA approves oral nimodipine solution for enteral use only


An oral liquid formulation of nimodipine has been approved by the Food and Drug Administration to help reduce serious and fatal medication errors that have occurred when the drug is extracted for intravenous administration from the only previously approved formulation, a liquid-filled gel capsule, the agency announced on May 14.

The nimodipine oral solution was approved on May 10 for improving neurologic outcomes in adults who have had a subarachnoid hemorrhage. The liquid-filled gel capsule formulation was approved in 1988.

Dr. Russell Katz

The new oral formulation, which will be marketed as Nymalize by Arbor Pharmaceuticals, can be administered orally or via a nasogastric or gastric tube, "and there is no need for a needle to be used, which is what caused past medication errors," Dr. Russell Katz, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in an FDA statement. "Having an oral version of this product may help reduce the medication errors we’ve seen from erroneous intravenous administration of the contents of oral capsules," he added.

The FDA has received reports of serious adverse events, including fatalities, associated with intravenous administration of the liquid contents of nimodipine capsules, including deaths, cardiac arrest, severe drops in blood pressure, and other cardiac complications. In 2006, a boxed warning was added to the prescribing information of nimodipine, a dihydropyridine calcium channel blocker, cautioning against intravenous use of the drug. And, in August 2010, the FDA issued a drug safety notice alerting health care professionals that nimodipine capsules should be administered only by mouth or through a feeding tube, and that it should "never" be administered intravenously.

The approved indication for liquid nimodipine is for the "improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V)."

The new formulation’s approval was based on clinical studies of nimodipine oral capsules in patients with subarachnoid hemorrhage. The prescribing information says that the bioavailability of nimodipine oral solution is comparable with that of nimodipine oral capsules, that hypotension is the most common adverse event in trials, and that blood pressure should be carefully monitored during treatment.

The prescribing information is available here.

Serious adverse events associated with Nymalize should be reported to the FDA’s MedWatch program or at 800-332-1088.

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