Reglan Side Effects Create Black Box Warning, Lawsuits

Reglan Side Effects Create Black Box Warning, Lawsuits

In February 2009, the FDA mandated that the gastrointestinal drug Reglan (and generics that include metoclopramide) display the strongest advisory the agency is capable of assigning to a prescription drug: the “black box” warning.
The use of metoclopramide can result in a condition called tardive dyskinesia, a serious neurological disorder affecting the face and lower limbs. In some cases the disorder can be permanent. This warning label was issued more than two decades after the drug in question first became available, and millions of people have since been prescribed Reglan or a generic equivalent.

Ramping Up Reglan Lawsuits

It is expected that the Supreme Court will deliver a major decision affecting the liability of generic manufacturers of this drug, most likely in June of 2011. The issue of whether or not the maker of a generic version of a drug may be held accountable for omitting a warning label that was never included on the original drug is one which has troubled state and federal courts for many years.
Currently, there are hundreds of Reglan lawsuits pending in several states. Plaintiffs of these lawsuits claim that they were never sufficiently warned about the severity of the side effects associated with metoclopramide.
Reglan was debuted by Wyeth (now a Pfizer subsidiary) in 1989. Schwarz Pharma acquired the rights to the drug in 2001, and only the generic metoclopramide form has been available since 2008.
Reglan, as well as its generic versions, was commonly prescribed as a remedy for gastrointestinal disorders such as diabetic gastroparesis or gastroesophageal reflux disease. Metoclopramide works as an antiemetic, or a drug that prevents vomiting. It also serves as a gastroprokinetic agent, which means that it helps users keep food down and also aids digestion.

Reasons for the Reglan Black Box

In 2009, when the FDA determined that all medicines containing metoclopramide must carry a black box warning, the agency cited two distinct studies which clearly illustrate the drug’s serious risk to users. More than 2 million Americans were taking metoclopramide as of February 2009.
One study found that metroclopramide was the primary cause of drug-induced movement disorders. Tardive dyskinesia belongs to this class of neurological disorders. A separate study found that a crucial portion of those taking metoclopramide had been instructed to continue taking the drug beyond the recommended maximum time of 3 months. This overconsumption seriously increased their risk of developing tardive dyskinesia.
Tardive dyskinesia, in plain language, means “delayed abnormal movement.” This disorder was first discovered more than 50 years ago, and is noted most often in psychiatric patients with a years-long history of taking antipsychotic medications. The most frequently reported symptoms are tongue thrusting, repetitive chewing, jaw swinging, and facial grimacing, according to Google Health.