The FDA has issued an order that the manufacturers of Reglan® place a black box warning describing serious drug side effects on all formulations containing metoclopramide of the risk of tardive dyskinesia developing from taking high doses of this drug or taking the drug for longer than 90 days. Patients most vulnerable to this risk are women, particularly elderly women, and those whose total cumulative dose is high.

The FDA is also requiring the manufacturer to submit a "Risk Evaluation and Mitigation Strategy" (REMS). This is a plan to inform health care professionals of the risks, the need to assess the risks in relation to the benefits of taking this drug, a method of assessing this risk to benefit relationship, and the need to inform the patient of the risks of taking this drug.

Tardive dyskinesia presents with involuntary muscle movements similar to Parkinson's disease. Jerking and twitching of facial muscles and limbs, including grimaces, protruding the tongue, blinking, and other facial distortions are among the symptoms. Tardive dyskinesia is untreatable, though the symptoms may decrease over several months following the final treatment with the causative drug. Rarely do the symptoms reverse completely.

The FDA originally approved Reglan® and metoclopramide for use prior to learning how many cases of tardive dyskinesia would result from its use. This outcome is associated with use longer than 90 days and high doses. After receiving numerous reports of new cases, the FDA issued these orders in an effort to prevent further adverse outcomes. For consumers, this is a clear signal about how dangerous this medication is.

It is the physician's responsibility to inform patients of the risks and benefits of medications they prescribe. If you are one of those affected by this medication, and particularly tardive dyskinesia, please contact Schlichter, Bogard & Denton, Pharmaceutical Attorneys in St. Louis, Missouri for a no-obligation, free consultation.