What is Reglan?
Reglan, also known as Metoclopramide, is a medication prescribed by doctors to treat heartburn caused by gastro esophageal reflux (GERD) for people who have not responded to other therapies. Reglan is also used to treat diabetic gastro paresis (slowed emptying of the stomach’s contents into the intestines). The FDA has recommended that treatment with such medications should not exceed three months.

Chronic use of Reglan has been associated with a movement disorder called Tardive Dyskinesia, which can continue to affect Reglan users after drug use has been discontinued.

What are the Symptoms of Tardive Dyskinesia?

• Involuntary/repetitive movements of the extremities
• Facial Tics
• Lip smacking, pursing and puckering
• Face Grimacing
• Tongue Protrusion
• Rapid eye movements or blinking
• Impaired movement of the fingers
• Restless Leg Syndrome (RLS)

What is the FDA’s position?
In early 2009, the FDA mandated that the makers of Reglan and other metoclopramide products add a black box warning to their labels regarding the risk of tardive dyskinesia associated with chronic, long-term use. According to the FDA, the current labeling for Reglan and similar drugs warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. In addition to the new Black Box, which is the agency’s strongest safety warning without pulling the medication from being sold, the FDA is also requiring the makers of metoclopramide-containing drugs to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses the dangers of using these medications in high doses, or over a long period of time. The FDA’s mandate followed the publication of analyses that suggested that metoclopramide is the most common cause of drug-induced movement disorders.

What is the Cure for Tardive Dyskinesia?
At this time, there is no treatment or cure. While stopping Reglan may relieve some symptoms in some patients, in other patients the symptoms of tardive dyskinesia actually worsen when Reglan is discontinued.

Cases are being filed against the manufacturers of these products for injuries caused to innocent consumers. Our firm prides itself in going beyond the recovery of money to achieve meaningful change that makes a difference not only to our clients but to our society as a whole. We seek to improve the warnings on products such as these so that future consumers are aware of associated risks and can make informed decisions. If you or someone you know has taken Reglan and been diagnosed with Tardive Dyskinesia, please contact our office.

To discuss a potential case, please call us at 1(800) 922-4851 or contact Jack Drake, or Ashley Cranford.