Pharmaceutical Drug Injury: Reglan

Reglan


Tardive Dyskinesia

Reglan (metoclopramide) is a neuroleptic drug used to treat a number of gastrointestinal conditions including diabetic gastric stasis and gastric reflux, or heartburn. Long term use of Reglan may be linked to some psychiatric and/or neurological disorders (e.g., tardive dyskinesia).

The FDA approved the neuroleptic drug Reglan for short-term (not long term use) treatment of the above mentioned gastrointestinal conditions. However, evidence shows that one-third of patients are prescribed the neuroleptic drug Reglan for longer than 12 weeks, which violates FDA recommendations.

Studies have shown that the use of the neuroleptic drug Reglan can cause Tardive Dyskinesia in as many as 27% of its long-term users. According to the FDA, more than 2 million people have taken Reglan for gastrointestinal problems.

According to many reports, Reglan may have a number of serious psychiatric disorders and/or neurological disorders and side effects, including Tardive Dyskinesia.

U.S. FDA Action

On February 26, 2009, the FDA notified healthcare professionals that manufacturers of metoclopramide (reglan) must add a boxed warning (black box) to their neuroleptic drug labels.

For a summary of the black box warning for Reglan (metoclopramide), click here.

For more on reglan cases, please follow this link.


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