Another Reglan Lawsuit Filed

New Orleans, LAAnother Reglan lawsuit has been filed, alleging the medication is responsible for a patient's nervous system disorder. In this case, the plaintiff is arguing about generic Reglan side effects. The US Food and Drug Administration (FDA) has issued a warning about the link between Reglan and tardive dyskinesia—a link that is believed to extend to generic versions of the drug.

The lawsuit was filed June 11 by Isreal Bennett, according to the Louisiana Record on 6/23/10. The plaintiff alleges he took Reglan to treat reflux for approximately five months, from December 2008 through May 2009. He says he was later diagnosed with tardive dyskinesia.

According to the lawsuit, the defendant gave inaccurate and misleading information concerning the long-term use of Reglan. Reglan is currently approved for short-term treatment of gastroesophageal reflux, but many patients were prescribed Reglan for long-term use, well beyond the three-month maximum recommended by the FDA.

The plaintiff seeks damages for medical expenses, physical impairment and mental anguish, along with other damages. The defendant in the lawsuit is Qualitest Pharmaceuticals, maker of metoclopramide (the generic version of Reglan).

Patients who use metoclopramide long-term are at increased risk of developing tardive dyskinesia, a condition that causes involuntary and repetitive movements, include grimacing, lip smacking, lip puckering and repetitive movement of the extremities.

According to the FDA's news release, published studies suggest metoclopramide is the most common cause of drug-related movement disorders such as tardive dyskinesia.

In February 2009 the FDA announced that makers of metoclopramide medications must add a boxed warning to the drug labels alerting patients to the risk of long-term use.

Reglan is also used for pregnant women to alleviate extreme morning sickness. One lawsuit now alleges that the drug was responsible for a child's physical difficulties. The mother says she started Reglan during her seventh week of pregnancy and continued on it for approximately four weeks. At 36 weeks, she gave birth to her son, who was born with unexplained physical disabilities.

The plaintiffs in the lawsuit have also filed a complaint seeking a review by a panel of medical experts of the use of Reglan. The lawsuit alleges that the defendants failed to properly prescribe the medication, failed to monitor and evaluate the patient and failed to warn or advise health care providers or the patient.