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FDA Requires Black Box Warning for Label of Gastrointestinal Drug Reglan

By July 28, 2009July 17th, 2019Dangerous Drugs

The U.S. Food and Drug Administration has ordered makers of a drug for digestive problems to add the strongest warning possible to its label, WebMD reported earlier this year. The “black box” warning will caution patients about the risk of developing a serious and potentially incurable muscle disorder called tardive dyskinesia after taking Reglan (metoclopramide). Patients with tardive dyskinesia have involuntary, repetitive muscle spasms, including pursing and smacking of the lips, grimacing, sticking out the tongue and rapid blinking. Patients taking Reglan who have noticed these effects are encouraged to contact the FDA to report any problems with the medication.
According to the FDA press release, two million Americans take some form of Reglan. It is used primarily to treat nausea and vomiting due to certain kinds of cancer treatments, infection, drug side effects and pregnancy, as well as for diabetics with digestion problems. Tardive dyskinesia is a known side effect of Reglan, which is why the FDA recommends that patients use the drug for no more than three months at a time. However, the agency ordered the more stringent warning after recent analyses found that Reglan is the most common cause of drug-induced movement disorders. The agency had also received continuing and spontaneous reports of patients developing tardive dyskinesia after using Reglan. Reglan was also the subject of a defective drug lawsuit in California, in which drug maker Wyeth was held liable for its failure to warn patients about the risk of tardive dyskinesia.
Tardive dyskinesia is a side effect of prolonged or high-dose use of dopamine antagonist medications, including antipsychotics and neurological drugs as well as Reglan and other gastrointestinal drugs. The condition may be mistaken for Parkinson’s disease, but while Parkinson’s patients have trouble moving, tardive dyskinesia patients have trouble not moving. These patients experience involuntary, rapid and repetitive movements, especially movement in the face, fingers and extremities. The movements may or may not disappear after the drug is stopped, and they may take years to subside. There is no known cure for tardive dyskinesia, which is why medical professionals focus on preventing it by limiting the use and dosage of the drugs that cause it.
As a dangerous drug injury attorney, I noticed that Reglan is part of a class of drugs normally used to manipulate the brain chemistry of patients with menal illness or neurological disorders. That’s one reason why Reglan’s side effects include tardive dyskinesia and other neurological symptoms, from drowsiness and dizziness to neuroleptic malignant syndrome. This is too high a price to pay for relief from nausea and vomiting. As the FDA said, this black box warning on Reglan should help patients and doctors make an informed decision about whether the risks are worth the benefits. But for the millions who have already taken Reglan, it may be too late. If an investigation shows that Wyeth and others failed to adequately warn patients of the risk of tardive dyskinesia before the labeling change, patients who develop this terrible, incurable disability have the right to sue the drug makers.

Carey, Danis & Lowe specializes in representing people who were seriously hurt by taking a prescription drug that was supposed to help. Our pharmaceutical injury attorneys help patients and their families hold drug manufacturers legally liable for injuries caused by flaws in their medication, or lack of warning about potentially dangerous side effects. In a lawsuit, these patients may claim all of the financial costs of the injuries and illnesses the drugs caused, including past and future medical costs to treat the effects of the drug as well as lost income when the victim cannot work. They can also claim compensation for their injuries, physical pain, emotional suffering and any permanent disability caused by the dangerous drug. Based in St. Louis and Belleville, Ill., we help people throughout the United States.
If you or a loved one developed severe side effects after taking Reglan or any other prescription drug, the Lowe Law Firm can help. To learn more about your options and your rights at a free, confidential consultation, you can call us toll-free at 1-877-678-3400 from anywhere in the United States or contact us via email.