The United States Food and Drug Administration recently required the makers of the drug Reglan to include a black box warning about Tardive Dyskinesia.

A black box warning, also known as a black label warning or a boxed warning, is a type of warning that appears on the package insert for prescription drugs that can cause serious adverse effects. The name comes from the black border that usually surrounds the text of the warning.

A black box warning means that medical studies indicate that the drug carries a significant and substantial risk of serious or life-threatening adverse effects. The U.S. Food and Drug Administration can require a pharmaceutical company to place  a boxed warning on the labeling of a prescription drug or any literature detailing it. It is the strongest warning the FDA requires.

The FDA has linked use of the drug Reglan to the debilitating and incurable movement disorder Tardive Dyskensia. For sound legal advice and assistance regarding Reglan side-effects and injury liability, please contact the Reglan Tardive Dyskinesia lawyers of Williams Kherkher today at 800-781-3955.