Reglan Requires FDA Approved Black Box Label Warning

High or extended use of neuroleptic drugs cause an untreatable conditions that is known as Tardive Dyskinesia.  The symptoms of tardive dyskinesia include muscle spasms, lip smacking, rapid eye movements, repetitive blinking, lip pursing, and dysfunctional finger movements.  If a patient ceases taking causative drugs, the symptoms may slightly reduce, but in fact, will never leave their entirely. 

Metoclopramide, which is the main ingredient in Reglan, is the most heavily associated medication with tardive dyskinesia.   Metoclopramide treats common ailments such as heartburn, acid reflux, and other gastrointestinal disorders, as well as some psychological and neurological conditions.  In all formulations of Reglan, including injection, oral solution, or pills, there are concentrations of Metoclopramide. 

The FDA’s Reasoning on Label Change Requirements

The dangers of Reglan in relation to tardive dyskinesia were well known, even before the black box mandate, to the FDA, but at the time, the FDA was unaware of the actual high level of risk that the drug actually did pose.  An ANDA (Abbreviated New Drug Application) filing took place, and since the release of the drug Reglan under these auspices, the sheer number of persons afflicted with tardive dyskinesia after taking Reglan forced the FDA to respond and mandate the black box warning label.  The label specifically notes the risk for tardive dyskinesia associated with high dose amounts or prolonged exposure to Reglan for more than three months.  Other notable increased risk factors include patients who are female, older in age, and the long-term amount of the drug actually consumed. 

Further Requirements by the FDA on Reglan 

Reglan’s manufacturers must also present a REMS, or Risk Evaluation Mitigation Strategy, to the FDA concerning informing healthcare providers of the risks associated with Reglan versus the benefits from using the medication. Other requirements include providing a medication guide and the plan for informing healthcare providers. 

Currently, an estimated two million patients in the United States take Metoclopramide in response to gastric issues.