UPDATE: On February 25, 2009, The U.S. Food & Drug Administration (FDA) required the manufacturers of metoclopramide-containing drugs (Reglan) to add a “Black Box” warning to the products warning of an increased risk of the development of Tardive Dyskinesia.
The Effects of Tardive Dyskinesia
Tardive Dyskinesia (TD) is a devastating and sometimes lifelong syndrome for those diagnosed. It affects its victims physically, mentally, socially, emotionally, and vocationally.
One of the worst aspects of Tardive Dyskinesia for many victims is the fact that they should have never developed the syndrome in the first place.
What is the Problem?
The manufacturers of Reglan and its generic metoclopramide mention the link between the development of Tardive Dyskinesia and the drug on its labeling, however they suggest the incidence rarely occurs.
It is important to understand that the Food & Drug Administration has only approved Reglan for short-term use (4 to 12 weeks) and only when conservative treatment fails.
Safety experts from the Duke University School of Medicine, publishing in the November/December 2004 Journal of the American Pharmacists Association, caution that the use of Reglan is increasing and that this fact may result in more cases of drug-induced movement disorders from the medication.
Long-term use can cause serious Reglan side effects, including Tardive Dyskinesia.
FDA Warning on Reglan
Below, is a video published by the U.S. Food & Drug Adminsitration (FDA), which discusses the “Black Box” warning and the increased risk of the development of Tardive Dyskinesia among users of Reglan.