FDA approves Reglan label changes to reflect black box warning
July 15th, 2009 by Jennifer Walker-Journey
The Food and Drug Administration (FDA) has approved the safety labeling changes of the heartburn and gastroparesis medication Reglan (metoclopramide) which includes a black box warning of a serious and often irreversible movement disorder called Tardive Dyskinesia. The warning includes Reglan (metoclopramide) tablets, ODT (orally disintegrating tablets), and injection.
Tardive Dyskinesia (TD) is a disfiguring disorder characterized by involuntary movements of the face, tongue or extremities. Symptoms can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. The symptoms do not always go away after discontinuation of the medication.
The new labeling warns consumers and health care providers that the risk of developing TD increases with duration of treatment and total cumulative dose.
“Although the risk of TD with metoclopramide has not been extensively studied, one published study reported a TD prevalence of 20 percent among patients treated for at least 12 weeks,” the new warning states.
The labeling warns consumers and health care providers not to use the treatment for more than 12 weeks except in rare cases where the therapeutic benefit outweighs the risk of developing TD. Elderly are at greater risk, but any patient who develops signs of symptoms should stop taking the medication immediately. Metoclopramide may also suppress or partially suppress the signs of TD, thereby masking the underlying disease process.
If you or a loved one have been injured by Reglan side effects, you may have a claim against the manufacturer.
Source: FDA