Reglan® Warning

By order of the U.S. Food and Drug Administration (FDA), a black box warning about the dangers of contracting tardive dyskinesia was added early in 2009 to the label of all medicines containing the generic drug metoclopramide. The brand name for metoclopramide is Reglan®. Warnings contained in a black box on drug labels are the strongest type of warning the FDA issues.

Patients and doctors are warned that taking the drug for longer than 12 months at increased doses can cause tardive dyskinesia. The condition is often irreversible, even when the drug is stopped.

Tardive dyskinesia is a movement disorder occurring in older patients, especially in older woman. It is characterized by abnormal movements that include:

  • Tongue thrusting
  • Rapid blinking of the eyes
  • Grimacing
  • Puckering and pursing of the lips
  • Impaired finger movement

These symptoms are most likely to occur in patients taking high cumulative doses of the drug for longer than 12 months, according to the warning.

"The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk," the FDA warning says.

Reglan® speeds the emptying of the contents of the stomach and small intestines. It is used often for:

  • Heartburn and GERD (gastroesophageal disease)
  • Type 1 and type 2 diabetics who have a "lazy stomach" which doesn't empty fast enough. When this happens, the body has a more difficult time regulating blood glucose levels.
  • Nausea and vomiting in cancer chemotherapy patients
  • Nausea and vomiting after surgery
  • To help empty the stomach for x-rays

The medication works by activating the muscles of the stomach and small intestine. The stomach is connected to the esophagus at its top and the muscles of the small intestine at its bottom. Reglan® helps the muscles at the top of the stomach tighten while helping those at the bottom of the stomach to relax.

The FDA refers to recently published reports that suggest that metoclopramide is the medication most responsible for drug-induced movement disorders.

Side Effects Related to Reglan®

Generally, the incidence of Reglan® side effects correlates with how long the patient has been taking it. Aside from tardive dyskinesia, side effects from taking Reglan® can include:

  • Low energy
  • Diarrhea
  • Dizziness
  • Drowsiness
  • Headache
  • Nausea
  • Restlessness
  • Tiredness
  • Trouble sleeping
  • Agitation
  • Mental depression
  • Parkinson's disease-like symptoms such as slow walking, rigidity, a mask-like facial expression
  • Anxiety, jitteriness, insomnia, inability to sit still, pacing
  • Diarrhea
  • Visual disturbances
  • Hypertension and hypotension
  • Rapid heart beat
  • Fluid retention
  • Acute congestive heart failure
  • Urinary frequency
  • Incontinence

If you've suffered a serious Reglan® side effect such as tardive dyskinesia, an attorney may be able to help you recover financial compensation. To learn more, contact a tardive dyskinesia attorney today.