Reglan Warnings Boosted in Canada

<"http://www.yourlawyer.com/topics/overview/Reglan">Reglan (metoclopramide) warnings have been increased in Canada for tardive dyskinesia, a serious movement disorder and known Reglan side effect.

Health Canada is advising health professionals and consumers that Reglan labeling is being updated for stronger tardive dyskinesia warnings. Symptoms of tardive dyskinesia include involuntary/repetitive movements of the extremities; facial tics; lip smacking, pursing, and puckering; face grimacing; tongue protrusion; rapid eye movements or blinking; impaired movement of the fingers; and Restless Leg Syndrome (RLS).

There is no treatment or cure for tardive dyskinesia. Stopping Reglan may relieve some symptoms in some patients, in other patients the symptoms of tardive dyskinesia actually worsen when Reglan is discontinued. The longer the treatment the greater the risk, especially in senior women.

The prescription drug Reglan has been available in Canada since 1975 and is typically used to treat digestive problems associated with a stomach that empties too slowly. Reglan works by helping to speed food through the stomach and intestines.

In February 2009, the U.S. Food & Drug Administration (FDA) mandated that the makers of Reglan add a black box warning to its label regarding the risk of tardive dyskinesia associated with chronic, long-term use. The FDA’s mandate followed the publication of analyses that suggested that Reglan is the most common cause of drug-induced movement disorders. A black box is the FDA’s strictest safety warning.

While the Canadian labeling says that tardive dyskinesia is a known side effect of metoclopramide, Health Canada is working with Canadian manufacturers to include stronger, more detailed warnings that contain the following information:

• Tardive dyskinesia may develop in patients treated with metoclopramide. The elderly, especially elderly women, appear to be at increased risk.
• The risk appears to increase with treatment length and the total amount of drug taken.
• Tardive dyskinesia is more likely to be irreversible with long-term treatment (over 12 weeks).
• Less frequently, tardive dyskinesia can develop with short-term treatment at low doses; in these cases, the symptoms are more likely to disappear either partially or completely over time, once treatment has been stopped.
• Tardive dyskinesia may not be easy to recognize in early stages.
• Metoclopramide treatment beyond 12 weeks should be avoided, unless the benefit is judged to outweigh the risk.

Health care professionals are reminded that metoclopramide has not been approved in Canada for the treatment of hiccups, diabetic gastroparesis (partial paralysis of the stomach), nausea and vomiting in pregnancy, or for symptoms of bloating or constipation associated with eating disorders. Metoclopramide is available in various strengths and forms, including as a solution for injection, or as liquid or tablets that can be taken by mouth. It is sold under generic names only.

As we’ve previously mentioned, to prevent tardive dyskinesia, Reglan should not be taken for more than 12 months. Reglan has not been approved for longer use; however, it has become apparent that doctors have been prescribing Reglan for much longer periods.

Scores of people from around the country have filed tardive dyskinesia lawsuits against Wyeth Pharmaceuticals, the maker of Reglan. Reglan tardive dyskinesia lawsuits allege that Wyeth Pharmaceuticals knew of a widespread tendency among physicians to misprescribe Reglan and promoted the drug for longer use despite the lack of safety data to support such uses.

This entry was posted in Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.