Sam Brand – Legal Marketing Innovations, LLC. Dec. 28, 2010
Reglan Side Effects Prompt Late ʻBlack Boxʼ Warning After 20 years on the market, a popular gastrointestinal drug gets a serious warning label as lawsuits pour into courts. In February of 2009, the FDA required that gastrointestinal drug Reglan and generics containing metoclopramide carry a “black box” warning indicating the drug can cause tardive dyskinesia, a serious and sometimes permanent neurological disorder that affects the face and lower limbs. The FDA imposed the “black box” warning – the strongest warning the agency can put on a prescription drug – after it had been administered to millions of people over two decades without the warning. Hundreds of Reglan lawsuits are currently pending across several US states with plaintiffs claiming they were not adequately warned about the drugʼs serious side effects. In June of 2011, the Supreme Court is expected to deliver a major decision on whether generic manufacturers can be held liable for omitting a warning that was never included on the drugʼs original labeling, an issue that has long troubled state and federal courts. Introduced by Wyeth, now a subsidiary of Pfizer, in 1989, Reglan and its generics are prescribed to treat gastrointestinal disorders like gastroesophageal reflux disease and diabetic gastroparesis. The drug is an antiemetic (a drug that prevents vomiting) and gastroprokinetic agent (a drug that enhances physical gastrointestinal processes), helping those that take it keep down and digest food. In 2001, Schwarz Pharma acquired the rights to Reglan, and since 2008, the drug has only been available in generic metoclopramide form. In its 2009 “black box” decision, the FDA cited two studies that showed metoclopramideʼs serious risk to users. In one, researchers found that metoclopramide was the number one cause of drug-induced movement disorders, the class of neurological diseases that includes tardive dyskinesia. In another study, researchers found that a significant portion of metoclopramide users were instructed to use the drug for longer than the recommended maximum period of 3 months, significantly increasing their risk of developing tardive dyskinesia. Roughly translated as “delayed abnormal movement,” tardive dyskinesia was first discovered more than 50 years ago. It is most often seen in psychiatric patients who have been on antipsychotic medications for several years. According to Google Health, the most common symptoms of tardive dyskinesia are facial grimacing, jaw swinging, repetitive chewing and tongue thrusting. As of February 2009, more than 2 million Americans were using metoclopramide.