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

SOURCE: Reglan Side Effects › FDA approves Reglan label changes to reflect black box warning

“He has been sick ever since he was born,” writes Sam Weber. Karter was diagnosed with infantile spasms when he was just two months old, and has been on the medication Reglan for digestive problems since he was just two days old. He was recently taken off Reglan, and tested for West Syndrome, a seizure disorder, but the tests came out negative. “I have a feeling that he may have TD,” Sam Weber writes. “He continues to spasm and cry and stiffen up like he is in pain.”

The Weber’s concerns about Tardive Dyskinesia may be warranted. The Food and Drug Administration (FDA) recently issued a black box warning on Reglan and its generic metoclopramide after receiving reports that long-term use of the medication has been linked to an increased risk of Tardive Dyskinesia. Individuals with Tardive Dyskinesia develop involuntary movements of their muscles. Those movements include lip smacking, tongue thrusting, head jerking, facial grimacing, and involuntary movements of the fingers.

There is no known cure for Tardive Dyskinesia, and symptoms may persist even after the medication is discontinued.

SOURCE: Reglan Side Effects › Family asks, ‘Is this Tardive Dyskinesia?’