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FDA Issues Black Box Warning for Reglan Due to Serious Side Effects

A black box warning is used by the FDA to alert consumers to a significant risk of serious adverse effects associated with a particular drug. It is the highest level of warning that can be required by the FDA. On February 26, 2009 the FDA notified doctors that the manufacturers of Metoclopramide must add a black box warning to drugs containing Metoclopramide because of the risk of serious and typically irreversible side effects.

Metoclopramide Needs a Black Box Warning

This strong warning was issued because of the link between the drug and tardive dyskinesia. The FDA warned that the chronic use of metoclopramide has been linked to tardive dyskinesia which is a condition that can cause involuntary body movements. The condition can persist long after a patient stops using metoclopramide and it is most often irreversible. There is no known treatment for tardive dyskinesia which was one of the FDA's reasons for using the black box warning.

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FDA Alert: Reglan Gets Black Box Warning

Patients with tardive dyskinesia have involuntary and repetitive movements. Almost any part of the body can be affected and can include facial distortions, lip smacking, and finger movements. Many tardive dyskinesia patients feel ostracized and socially uncomfortable.

Parents Should be Concerned about the Metoclopramide Black Box Warning

Although Metoclopramide has never been approved for use in infants or children, many doctors have been prescribing Reglan to infants with gastroesophageal reflex disease (GERD). Reglan treats GERD by preventing stomach acids from reentering the infant's esophagus after the infant eats. However, the risks of Reglan may outweigh the benefits since infants may be at risk of developing tardive dyskinesia.

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Parents of infants taking Reglan should speak to their child's physician about the FDA's black box warning and how it applies to their child. A child who is taking Reglan should only be taken off the medication under a doctor's supervision.