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Reglan–New Black Box Warning

Reglan (generic: metoclopramide) is a drug used to treat heartburn and slow gastric emptying in diabetes patients. The danger that Reglan lawyers are investigating is tardive dyskinesia (also known as TD), a neurological disorder that manifests as repeated involuntary movements. Injured patients may experience grimacing, protrusion of the tongue, lip smacking, rapid eye blinking, and movement of the extremities. There is no treatment for tardive dyskinesia.

Not to say that heartburn isn’t painful, but how many of us would risk contracting tardive dyskinesia just to compensate for bad eating habits? Reglan lawyers have discovered that the label, unfortunately, minimized that risk, implying that there wasn’t much danger. The original label said it “may produce extrapyramidal reactions, although these are comparatively rare.” Other sections of the label likewise indicate that tardive dyskinesia is a low risk.

However, earlier this year the FDA required makes of Reglan and other metoclopramide medications to put a black box warning on their labels, the most stringent act the FDA can take. That label now reads:

Tardive Dyskinesia
Chronic treatment w/ metoclopramide may cause tardive dyskinesia, a serious, often irreversible movement disorder; risk increases with treatment duration and cumulative dose, and in elderly patients, especially women; Discontinue metoclopramide if signs or symptoms of tardive dyskinesia develop; avoid prolonged treatment over 12 weeks in all but rare cases where benefit may outweigh risk.

Reglan drug injury lawyers are accepting these cases on an individual basis—no class actions are filed, and none are expected. However, Reglan lawyers have petitioned for consolidation and/or coordination into an MDL (“MultiDistrict Litigation”). Basically, the hope is that these cases are grouped together for the purpose of common discovery, then individually litigated. If approved, this makes these cases more inexpensive for injured clients. The Judicial Panel on MultiDistrict Litigation (JPML) is hearing arguments for and against consolidation today. Rulings typically come within about 2 months after the hearing.

Our lawyers are investigating Reglan drug injuries subject to this new warning for patients with tardive dyskinesia. If you want to speak with a lawyer about potential lawsuits, call 800-553-8082 for a free Reglan lawsuit case evaluation.