Reglan is a drug for the treatment of ailments everyone has experienced at one time or another &mdash: nausea, vomiting and gastrointestinal problems. However, Reglan’s most serious side effect is a sometimes-irreversible condition that’s much rarer: tardive dyskinesia. Tardive dyskinesia is a disorder of involuntary, repetitive movements including lip smacking, grimacing, tongue protrusion and finger movements. Because patients with tardive dyskinesia cannot stop moving, the condition is disabling. That’s why Reglan’s manufacturer faces a growing number of lawsuits from Missouri Reglan lawyers.
Reglan is frequently prescribed to people who have gastrointestinal problems, including heartburn from gastroesophageal reflux disease (GERD) or difficulty emptying the stomach due to surgery or diabetes. It’s also prescribed for people who experience nausea because of pregnancy, chemotherapy, radiation and other conditions. All of these are long-term or chronic conditions, which means Reglan may be taken for weeks or months at a time. Unfortunately, studies of Reglan have found that long-term and high-dose use substantially raise the risk of developing tardive dyskinesia.
In 2009, the U.S. Food and Drug Administration told doctors and patients not to use Reglan for more than 12 weeks (three months) unless they believe the benefits outweigh the increased risk. It also announced that it would require a black box warning, the agency’s strongest, about the risk, and required manufacturers to institute a risk management program. These announcements were based on repeated reports to the FDA of Reglan side effects, as well as published studies connecting Reglan use to tardive dyskinesia. In one study, one-fifth of the patients used Reglan for more than the now-recommended 12 weeks. Studies also found that the risk of tardive dyskinesia increased with age and among women.
Tardive dyskinesia is believed to be exclusively or almost exclusively caused by long-term treatment with certain drugs. Until Reglan, those drugs were most commonly antipsychotic neuroleptic drugs. Like Parkinson’s disease, tardive dyskinesia is believed to be a problem of brain chemistry, and many of the same drugs are used in the treatment of both conditions. Sufferers experience a significantly decreased quality of life and may isolate themselves because of the social stigma their involuntary movements create. There is no cure.
Reglan has been available in the United States for more than a decade, but its popularity increased dramatically in the 2000s. More than 7 million prescriptions for Reglan were written during its peak in 2004. As a result, millions of Americans with common gastrointestinal problems could have been exposed to serious Reglan side effects. Lawsuits, including many filed by St. Louis Defective Drug Lawyers, are pending against Schwartz Pharma, the maker of name-brand Reglan. All of these suits allege that the manufacturer failed to adequately warn patients about the risk of developing a life-changing, disabling case of tardive dyskinesia.
E. Ryan Bradley represents patients and families that suffered serious harm due to their use of Reglan. Our Missouri Drug Recall Attorneys help patients hold negligent drug companies legally responsible for the medical and personal injuries they suffered after taking a medication they thought they could trust. Like all manufacturers, drug makers owe consumers a duty not to make and sell defective drugs, including drugs that carry inadequate warnings about a serious and irreversible neurological disorder. In a lawsuit, patients who have developed tardive dyskinesia can claim damages for all of their injuries. This includes the costs of medical care, lost income for those who cannot work, and other financial costs, as well as compensation for their lost abilities and quality of life.
If you believe you or someone in your family developed tardive dyskinesia as a result of taking Reglan, don’t wait to call E. Ryan Bradley to discuss how we can help. For a free consultation, call 314-400-0000.