Black Box Warning for Metoclopramide Drugs



The Food and Drug Administration has issued a black box warning for drugs containing metoclopramide. Metoclopramide, used to treat gastrointestinal disorders, increases the risk of tardive dykinesia. Tardive dykinesia is characterized by repetitive and involuntary movements of the body, is irreversible and there is no known cure.

Tardive dykinesia may cause the following:

  • Rapid eye movement or blinking
  • Puckering and pursing of the lips
  • Lip smacking
  • Grimacing
  • Protruding the tongue
  • Impaired movement of the fingers
  • Involuntary and repetitive movement of the extremities

Drugs containing metoclopramide include the popular Reglan tablets, including oral disintegrating tablets, metoclopramide oral solution, and injections. Over two million people take Reglan products. Tardive dykinesia was already noted with chronic metoclopramide treatment, but will now be highlighted in a black box warning.

This disorder is more prevalent in the elderly, especially women and those who have taken metoclopramide for as little as three months. While it is irreversible, the symptoms seem to lessen when the patient stops taking the drug.

Metoclopramide speeds up the movement of the stomach muscles, which helps by moving food to the intestines. It is used mostly on those who have gastroesophageal reflux disease and to treat diabetic gastoparesis. Treatment is recommended to go on no longer than three months.

If you are taking metoclopramide and have noticed any adverse effects, the FDA urges you to contact its MedWatch program. You should also contact your healthcare provider.