Reglan® Medication

Reglan® (metoclopramide) is a medication approved by the U.S. Food and Drug Administration to treat gastroesophageal reflux disease (GERD) and diabetic gastroparesis.

GERD occurs when the stomach contents back up into the esophagus and can cause heartburn and discomfort. It is treated by oral (fluid or tablet) doses of Reglan® four times daily: once before meals and at bedtime.

Diabetic gastroparesis occurs in some diabetic patients who have damage to the vagus nerve. The disorder prevents the stomach contents from moving rapidly enough into the small intestine. The medication helps the stomach to move its contents to the small intestine affecting the muscles of those organs.

It works by making the muscle at the top of the stomach tighten to keep food from backing up the esophagus and the muscle at the bottom of the stomach relax to allow the contents to flow more freely into the small intestine.

Other uses for Reglan® include:

  • To prevent nausea and vomiting after surgery
  • To prevent nausea and vomiting associated with chemotherapy
  • To facilitate small bowel intubation
  • To help empty the stomach for x-ray exams

Reglan® Medication

When used properly, Regan® can be effective in helping the stomach empty its contents into the small intestine. Proper dosage and timing of administration of the drug are important for it to work well. In some persons, however, especially those who have taken Reglan® in higher than recommended doses for an extended period of time (over 12 weeks), the medication can have serious side effects.

Precautions and Warnings

In 2009, the U.S. Food and Drug Administration (FDA) added a black box warning to the medication label, cautioning physicians and patients that if used for too long or in too high a cumulative dose, Reglan® could cause tardive dyskinesia. A black box warning is the most urgent warning the FDA can put on a drug label.

Tardive dyskinesia is a severe movement disorder that may be irreversible, even when the medication is stopped. Symptoms of tardive dyskinesia include:

  • Abnormal movements of the face, arms, legs and fingers
  • Facial movements include grimaces, rapidly sticking the tongue out, quick blinking and smacking and puckering of the lips

The label warning says that patients should avoid taking Reglan® for more than 12 weeks because of the risk of tardive dyskinesia. The boxed warning cautions:

"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 tardive dyskinesia."

The medication label also warns that Reglan® may in certain patients cause Parkinson's disease-like symptoms, and aggravate hypertension, fluid retention and blood volume overload.

Reglan® and Pregnancy

Reglan® is in a Class B pregnancy category. That means there is no evidence of harm in rats, mice and rabbits through various routes (intramuscular, intravenous, subcutaneous, and oral) to the fetus caused by metoclopramide. The category information cautions that there are no well-conducted, adequately performed tests in pregnant women and that animal studies do not completely predict how humans will respond. Therefore, the drug should be used during pregnancy only if the need is evident.

For more information about the medication, contact a Reglan® attorney today.