Reglan Linked to Tardive Dyskinesia

Reglan, also called metoclopramide, is a drug commonly prescribed to treat gastrointestinal disorders in infants such as gastroesophageal reflux disease (GERD), nausea, and vomiting. Reglan, however, has not been approved by the FDA for use in infants and children and has been shown to produce abnormalities in the brain which result in Tardive Dyskinesia, a permanent and severe condition. There is also a possibility that Tardive Dyskinesia can occur in infants due to the use of Reglan by their mother either during pregnancy or while breast feeding.

Infants with Tardive Dyskinesia have involuntary movements of the jaw, cheeks, mouth and tongue. Involuntary movements are also sometimes seen in the hands and abdomen of Tardive Dyskinesia patients. Often these symptoms do not develop while the patient is taking the full dose of medication so it is difficult to predict that the condition exists until the patient has lowered his or her dose or stopped taking the mediation. There is no known treatment for Tardive Dyskinesia. People who develop the condition in infancy will likely need to treat this condition for their entire lives. In February 2009, the Food and Drug Administration issued a stern public warning about the long term or high-dose use of Reglan by adults due to concerns about developing Tardive Dyskinesia. The drug is FDA-approved for short-term use for gastrointestinal disorders in adult patients who have not benefited from any other treatments. The FDA required the makers of Reglan and other metoclopramide drugs to add boxed warnings to the products’ labeling about the risks of high dose use or long-term use of the drugs in adults. The boxed warning states that treatment with Reglan or metoclopramide “for longer than 12 weeks” should be avoided in all but rare cases where the therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

Metoclopramide is also marketed under the names Pylomid, Octamide, Degan, Maxolon, Maxeran, and Primperan.

If you or your child has developed Tardive Dyskinesia after taking Reglan and other metoclopramide products then it is important to get medical and legal help as soon as possible. Manufacturers of medications such as Reglan and metoclopramide have been aware of the possible serious side effects for many years yet still continued to manufacture and market the drug. Your child and family may be eligible to receive financial compensation for medical bills, pain and suffering, and other damages paid by the drug company or other responsible parties. Contact one of our Reglan attorneys today for a free and confidential case evaluation.