FDA Increases Reglan Warning for Tardive Dyskinesia

Scott Kappes
Contributor
(866) 735-1102 Ext 346
Posted by Scott KappesMarch 20, 2009 3:40 PM

Recently the FDA announced that the heartburn drug, Reglan, and all other drug containing metoclopramide will now carry the administration’s strongest warning, the infamous “black box” warning. The label change was made to warn consumers, and health care professionals alike of an increased risk of developing tardive dyskinesia.

Tardive Dyskinesia is a movement disorder that involves repetitive involuntary movements or twitches.

The label of Reglan previous boxed warning; however, the seriousness of the risk of tardive dyskinesia will now be highlighted by the FDA’s strongest warning.

Patients taking Reglan should have been warned of the risk of tardive dyskinesia by their physician prior to being prescribed Reglan.

According to the FDA the risk of developing tardive dyskinesia increases the longer a patient takes Reglan. Higher doses of Reglan also increase a patient’s risk of developing tardive dyskinesia.

Metoclopramide drugs including Reglan are responsible for the majority of drug induced movement disorders. FDA studies suggest that about one out of every five patients who take Reglan or other metoclopramide drugs take them for a period of more than three month. These individuals are at the greatest risk of developing tardive dyskinesia.

If you or a loved one has been diagnosed with Tardive Dyskinesia and have taken Reglan or another metoclopramide medication we can help. Contact us today for a free case evaluation by an experienced Reglan lawyer.

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