FDA Warning Links Use of Prescription Drug Reglan to Tardive Dyskinesia

Austin, TXIf you are one of the more than two million people who has been prescribed Reglan, then you are probably concerned about recent reports linking the drug to serious Reglan side effects, which include a type of movement disorder called Tardive Dyskinesia. Reglan, the most commonly known brand name for the generic drug metoclopramide, now includes a black box warning about these potential side effects. However, for patients who developed Tardive Dyskinesia while using Reglan, that warning comes much too late.

Shamus B. Mulderig, Managing Attorney of the Pharmaceutical and Medical Device Litigation Department at Hissey Kientz, LLP, says that the furor surrounding Reglan dramatically increased in February, when the Food and Drug Administration made an important announcement regarding the medication.

"On February 26, 2009, the FDA announced that manufacturers of Reglan and metoclopramide were to add a 'black box' warning about the risks associated with the long-term and high-dose use of metoclopramide to their drug labels. The FDA also directed the same manufacturers to implement a risk evaluation and mitigation strategy to ensure patients are provided with a medication guide that discusses the risk," says Mulderig. "Metoclopramide has only been approved by the FDA for the short-term treatment of adults with certain gastrointestinal disorders. It has not been approved for long term use. Shockingly, a review of the statistical data reveals that more than 20% of patients had been taking the drug for more than 12 weeks."

Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, warned the public "the chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk."

Mulderig notes that the medical studies have revealed that the risk of developing Tardive Dyskinesia is directly tied to how long a patient has taken metoclopramide. In fact, recent studies have shown that metoclopramide is the single most common cause of drug-induced movement disorders such as Tardive Dyskinesia.

Symptoms include involuntary repetitive movements of the extremities, lip smacking, rapid eye movements, puckering and pursing of the lips and grimacing. Impaired movement of the fingers has also been reported as a symptom. It is important to note that Tardive Dyskinesia is a permanent condition.

"Unexplainably, there is no indication that the manufacturer of Reglan has conducted or supported any medical or scientific studies about the potential dangers or side effects of long-term use of Reglan," says Mulderig. "We have learned that individuals have been taking Reglan for years, which is expressly contraindicated under the FDA's approval of the drug. We believe that the fact manufacturers have not conducted one single study about the risk of long-term Reglan use suggests that they are not interested in what they would find out if such studies were conducted.

"The manufacturers' drug labels misled the public about the dangers of this drug and downplayed the link between the use of Reglan and Tardive Dyskinesia. They downplayed the fact that Tardive Dyskinesia is a permanent condition."

Although lawsuits have already been filed, it is not too late for patients who have experienced any side effects of Reglan to contact an attorney.

"Certainly, this litigation is in its infancy," Mulderig says. "Patients who have been diagnosed with Tardive Dyskinesia or other movement disorders should immediately contact an attorney to determine if they may have legal recourse."