Reglan, Alaven Pharmaceutical’s drug containing metoclopromide, got strong medicine from the Food and Drug Administration (FDA). The drug was approved for short term treatment, under 12 weeks, of gastroesophageal reflux disease (GERD) and other stomach and digestive tract ailments. However, many patients took Reglan for much longer than the recommended time frame of 12 weeks.

The FDA issued a “black box” warning for Reglan as well as generic forms of metoclopromide. A Black box warning is one of the strongest label requirements the FDA can place, and means that  medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.

Reglan has been linked to Tarkive Dyskinesia. Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. Some mistake Tarkive Dyskinesia for Parkinson’s disease tremors. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.