July 16, 2009 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of the risk for metoclopramide-induced tardive dyskinesia; and the potential for adverse cardiovascular events, probable dementia, and breast cancer in patients receiving long-term estrogen-progestin therapy. Metoclopramide (Reglan) Linked to Risk for Tardive Dyskinesia On June 30, the FDA approved safety labeling revisions for metoclopramide tablets, orally disintegrating tablets, and injection (Reglan; Alaven Pharmaceuticals, LLC) to include a boxed warning regarding the risk for tardive dyskinesia (TD). TD is a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk for the development of metoclopramide-induced TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose; other factors may include older age, female sex, and the presence of diabetes mellitus. In 1 published study, TD was reported at a prevalence of 20% among patients receiving metoclopramide for at least 12 weeks. Metoclopramide therapy should therefore be limited to a 3-month period unless its therapeutic benefit is thought to outweigh the risk for the development of TD. Metoclopramide should be discontinued in patients in whom signs or symptoms of TD develop. Although there is no known treatment of the disorder, symptoms may lessen or resolve within several weeks to months after metoclopramide therapy is stopped. The FDA notes that use of metoclopramide can also suppress signs of TD, thereby masking the underlying disease process. Metoclopramide should not be used for the symptomatic suppression of TD because its long-term effects are unknown. Metoclopramide is indicated for the short-term (4 - 12 weeks) treatment of gastroesophageal reflux disease in patients in whom failure to respond to conventional therapy occurs and for the treatment of symptoms of diabetic gastroparesis. ============== Christia Bridges-Jones, IBCLC Chandler, AZ *********************************************** Archives: http://community.lsoft.com/archives/LACTNET.html To reach list owners: [log in to unmask] Mail all list management commands to: [log in to unmask] COMMANDS: 1. To temporarily stop your subscription write in the body of an email: set lactnet nomail 2. To start it again: set lactnet mail 3. To unsubscribe: unsubscribe lactnet 4. To get a comprehensive list of rules and directions: get lactnet welcome