Blackbox Warning Recommended for Class of Stomach Drugs

Washington (HealthKnowItAll) Regulators with the USFDA have recommended that a class of drugs used to treat people with certain stomach disorders need to come with a blackbox warning.

The warning is due to evidence of involuntary, repetitive movement on several parts of the body in people known as tardive dyskinesia.

This odd condition results in repetitive movements of the limbs, lip smacking, grimacing, tongue protrusion and rapid eye movements.

The drugs contain an ingredient called metoclopramide which is believed to be the cause of the condition.

Regulators say that people taking the class of drugs for a long period of time, or in high doses are at risk of developing the condition.

It is estimated that more than 2 million Americans use this class of medicine each year to treat a wide array of stomach ailments including heartburn.

“The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.