BETHESDA, MD 28 June 2012—Because newborns have accidentally received injections of Methergine instead of vitamin K and hepatitis B vaccine, Novartis Pharmaceuticals Corporation is telling health care professionals to store the ergot alkaloid separately from other injectable pediatric medications.
Novartis, holder of the new drug application for the Methergine brand of methylergonovine maleate, also wants health care professionals to administer medications to newborns in a setting other than in the mother's room.
The advice comes in the form of a "Dear Healthcare Professional" letter dated June 2012 and attached to the revised Methergine labeling (PDF) that FDA approved June 25.
Mix-ups involving methylergonovine injection and other medications in the obstetrics area of hospitals have been reported for several years by the Institute for Safe Medication Practices.
Descriptions of those mix-ups, however, focused on injections into the mothers, not the newborns.
Novartis's effort to incorporate information about the medication errors into Methergine's labeling began while the company still sold the ergot alkaloid in the United States, according to FDA.
Novartis notified FDA in February 2012 about discontinuing the sale of Methergine tablets and injection in the United States, a company spokeswoman said. She added that the company does not currently manufacture or market any form of Methergine.
Two other companies—Luitpold Pharmaceuticals Inc. and Ergoject LLC—have FDA's approval to market generic versions of Methergine, according to the database Drugs@FDA.
Luitpold manufactures methylergonovine maleate injection for distribution by subsidiary American Regent Inc.
Ergoject apparently has permitted the use of its abbreviated new drug application by Akorn Inc. The application number declared by Akorn in the National Drug Code Directory is the same as the number assigned to Ergoject.