Health Canada is updating its Reglan warnings concerning tardive dyskinesia, a neuro-muscular disorder whose symptoms include involuntary limb movements, Restless Leg Syndrome, lip smacking, facial contortions, and rapid eye movement. There is no known cure for tardive dyskinesia and the contraction of the disorder increases the longer a patient is taking Reglan. The drug has been available to patients by prescription since 1975 and is used to treat digestive disorders.
In February 2009, the US FDA added a black box warning to Reglan. The black box warning is the most serious warning available in the FDA drug warning system. The FDA black box warning was related to Reglan’s association with tardive dyskinesia.