Representing Patients Suffering Side Effects From Reglan

The Food and Drug Administration approved the drug Reglan for the treatment of gastrointestinal disorders/gastro-intestinal reflux disease.

Reglan is manufactured and marketed by Actavis, Inc. Reglan has been linked to a severe neurological condition known as Tardive Dyskinesia (a severe neurological condition that causes the body to shake and tremor violently).

In 1985, the FDA required that Reglan’s label be updated to include a warning regarding the risk of developing tardive dyskinesia. Actavis, Inc., revised its labeling to comport with these changes to the Reglan label.

In February 2009, the FDA issued another labeling revision for Reglan (metoclopramide) meant to warn of the risk of prolonged use, defined as use for more than 12 weeks. The general claims against Actavis Inc., include:

• failure to warn of the risks of neurological disorder after long-term use of metoclopramide
• ignoring scientific and medical literature establishing a higher risk of developing tardive dyskinesia
• failing to request a labeling revision from the FDA
• failing to change the label itself even though no prior FDA approval was required
• failing to report safety information directly to the medical community

Manufacturers of generic drugs such as Reglan must promptly update their warning labels to properly and timely advise consumers of the dangers associated with their drugs and discourages drug manufacturers from hiding the risks of their drugs from doctors and consumers.

If you believe you were harmed by using Reglan, contact us to evaluate your case.