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FDA issues black box warning for Reglan
Medication commonly used to treat heartburn linked to permanent involuntary muscle movement
Recently the FDA required the manufacturers of the drug metoclopramide, more commonly know as Reglan, to place a black box warning on its label. A black box warning is the strongest warning that the FDA can require.
Metoclopramide increases muscle contractions in the upper digestive tract, which speeds up the rate at which the stomach empties into the intestines. It is used short-term to treat heartburn caused by gastrophageal reflux, and also used to treat slow gastric emptying in people with diabetes, a condition called diabetic gastroparesis.
However, in recent studies, it has been shown that people taking metoclopramide can develop a serious condition called Tardive Dyskinesia.
Tardive Dyskinesia is a condition in which a person develops involuntary movements of their muscles which could 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.
Long-term users of the drug, and elderly patients, especially women are at an increased risk of developing Tardive Dyskinesia. There is no known cure for Tardive Dyskinesia and even after discontinuing the drug, symptoms may still persist.
The FDA has advised physicians to avoid long term use of metoclopramide except in rare cases where the benefit outweighs the risks.
Metoclopramide is available in formulations including tablets, syrups and injections, under names including Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injections. According to the FDA, it is estimated that more than 2 million American use these products.
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Researchers in Sacramento, Calif., are looking for people who still experience troublesome symptoms of gastroesophageal reflux disease (GERD) even while taking heartburn medication, to participate in a study to evaluate an investigational heartburn treatment.
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