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More Warnings Needed on Reglan Side Effects

Reglan's Black Box Warning

Reglan® was approved by the FDA in 1983. The original safety labeling of the drug was very weak and failed to adequately warn about the risk of side effects like tardive dyskinesia and its particular risk associated with long term use. Metoclopramide is only approved for short term use since treatment exceeding 12 weeks dramatically increases the risks of developing tardive dyskinesia. According to the FDA, however, approximately 20 percent of patients are currently taking the medication for 12 weeks or longer. The FDA also said that recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders.

On February 26, 2009, the FDA ordered manufacturers of the drug to enhance the prescription labeling and to add a Black Box Warning for metoclopramide.

The black box label, the agency’s most serious type of warning, alerts physicians about the risks associated with long-term metoclopramide use.

Black Box Label

Tardive Dyskinesia

Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.

Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.