The United States Food and Drug Administration (USFDA) has approved Nymalize, a first oral formulation of Nimodipine that can potentially lower fatal medication errors. Nymalize is indicated for the treatment of subarachnoid haemorrhage. Prior to approval, Nimodipine was marketed as a liquid-filled gel capsule.
Nimodipine should be administered only by certified healthcare professional in a critical care setting for the management of subarachnoid haemorrhage complications. The drug is to be manufactured by Arbor Pharmaceuticals Inc.,
As an emergency procedure, intensivists administer oral Nimodipine liquid contents intravenously that resulted in serious complications including cardiac arrest, severe hypotension and even death. The USFDA had received reports of such adverse events, over the years.
Three years ago, the health regulatory agency warned the healthcare professionals about the potential risk of intravenous administration of Nimodipine oral formulation. However, the agency added a Boxed Label Warning in 2006 against the IV use of Nimodipine.
According to Dr. Russell Katz, Director, Division of Neurology Products, USFDA Center for Drug Evaluation and Research, approval of an oral formulation of Nimodipine could lower the serious medication errors as a result of IV administration of oral capsule contents.
Nymalize can be administered orally even by nasogastric intubation technique and hence there is no need of an intravenous injection that often cause medication error, Dr. Russell added.
The USFDA approved the drug based on the fast track designation and priority review processes. The agency believes the efficacy of Nymalize could either lower or ward-off the medication errors. USFDA approved Nymalize based on results of clinical trials in patients with subarachnoid haemorrhage.
The commonly reported adverse event of Nymalize was decreased blood pressure. The agency warned the healthcare professionals about the potential risk of hypotension during Nymalize therapy.
Find us on facebook