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Reglan, or generically known as metoclopramide, has been prescribed to treat gastroesophageal reflux disease, acid reflux disease, heartburn, post-surgery and chemotherapy nausea, and diabetic gastroparesis. An estimated 2 million people take the drug in pill, liquid, or injection form.
Generally, its side effects are minor. However, certain patients have developed tardive dyskinesia or neuroleptic malignant syndrome, the latter of which may occur from even short-term exposure and may be fatal or result in permanent disability.
After taking Reglan, patients developing neuroleptic malignant syndrome display signs of a high fever, sweating, unstable blood pressure, stupor, muscle rigidity, or autonomic dysfunction for close to two weeks.
Tardive dyskinesia, on the other hand, is a permanent condition characterized by repetitive, involuntary movements, including grimacing, sticking one’s tongue out, lip smacking, puckering, or pursing, eye blinking, rapid movement of arms, legs, and trunk, and impaired movement of the fingers. Even after stopping Reglan, patients are still at risk for developing this socially- and physically-disabling condition.
Along with these two severe side effects, Reglan users may have developed Parkinsonism, while others already diagnosed with Parkinson’s disease saw their symptoms worsen.
Off-Label Usage and Warnings
The FDA only approved Reglan for short-term usage; however, approximately 30 percent of patients are prescribed it for periods of 12 months or longer, which increases risks of developing tardive dyskinesia.
As well, doctors have recommended it for off-label usage, including for pregnancy-related nausea, morning sickness, lactation simulation, migraine treatment, and radiation-related nausea.
While Reglan has been on the market for 30 years, its relationship with tardive dyskinesia development was known before the 1990s. However, Cisapride, or Propulsid, replaced it on the market during that decade, but once it was removed by 2000, recommendations for Reglan increased – by doctors who should have already known about the dangerous side effects.
Likely in response, the FDA requested Reglan have a black box warning after 2009, specifying a three-month limit and risk of developing tardive dyskinesia.
Although lawsuits concerning Reglan’s side effects have gone on for a number of years, they began increasing after the FDA’s 2009 warning. Plaintiffs allege in these product liability suits that the medication has unreasonably dangerous side effects and that doctors and pharmacists did not sufficiently warn patients.