Tardive dyskinesia

Reglan Warnings and Precautions

Reglan and Tardive Dyskinesia

Reglan® Black Box Warning

The Food and Drug Administration (FDA) required Reglan® and other metoclopramide-containing drugs to have a black box warning—the strongest warning possible—starting in February 2009. The black box warning is prominently featured on Reglan’s labeling and states the following:

WARNING: TARDIVE DYSKINESIA

Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. The elderly, especially elderly women, are most likely to develop this condition.

Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, in some patients symptoms may lessen or resolve after metoclopramide treatment is stopped.

Prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia.

Reglan and Depression/Suicidal Tendencies

Reglan has also been linked to depression in patients with no prior history of depression. Symptoms of Reglan-related depression range from mild to severe and include suicidal thoughts. Reglan has also been linked to suicide in some users.

Reglan and Parkinson’s Disease

Reglan has been linked to severe movement disorders known as tardive dyskinesia and tardive dystonia, which are sometimes confused with Parkinson’s disease (PD).

People with preexisting Parkinson’s disease symptoms are cautioned against Reglan use. This is because the active ingredient in Reglan (metoclopramide) blocks the neurochemical dopamine. Dopamine helps us move our bodies smoothly, such as raising an arm in one fluid motion versus raising it in jerky movements. Dopamine is already severely lacking in people suffering from Parkinson’s disease, and further limiting it by taking a metoclopramide drug like Reglan can worsen the disease.