Metozolv label has new tardive dyskinesia warning

The new chewable heartburn medication Metozolv, an orally disintegrating version of Reglan (metoclopramide), has added a warning to its label alerting users of a risk of the serious movement disorder Tardive Dyskinesia with long-term use of the drug. The change to the drug’s safety label was approved by the Food and Drug Administration (FDA) and announced this month.

The updated information to the drug’s WARNINGS section reinforces the Boxed Warning that was added to all metoclopramide-containing drugs in June 2009. The new warning states, “Treatment with metoclopramide can cause Tardive Dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of developing Tardive Dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization patterns showed that about 20 percent of patients who used metoclopramide took it for longer than 12 weeks. Treatment with metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.”

Metozolv, as well as all metoclopramide-containing medications, are only available by prescription. Metoclopramide is approved for the treatment of severe heartburn and acid reflux, gastroesophageal reflux disease (GERD), and gastroparesis, or delayed emptying of stomach contents. It is also used off-label to treat morning sickness. Many patients who require metoclopramide have difficulty swallowing. Metozolv is the first metoclopramide treatment available in an orally disintegrating tablet.