Man suffers permanent disability from heartburn drug
June 7th, 2010 by Jennifer Walker-Journey
When 57-year-old August Macaluso, a former nuclear-plant maintenance worker in Charlotte, N.C., began shaking violently, blinking incessantly and slurring his speech, he and his wife Sharon were both puzzled. Desperate for answers, Sharon Googled his symptoms and learned that the drug her husband had been taking for just three months was linked to the involuntary movement disorder Tardive Dyskinesia with frighteningly similar symptoms. He stopped taking the drug and after a battery of medical tests, doctors confirmed the Macalusoes’ worst fears. August had suffered permanent damage.
Reglan (metoclopramide) was approved by the Food and Drug Administration in 1979 for the short term treatment of various gastrointestinal disorders. But last year, after numerous adverse event reports, the FDA issued a black box warning – the strongest of its kind – on Reglan and generic versions of metoclopramide, stating that the medication had been linked to Tardive Dyskinesia. The movement disorder has been most often associated with some antipsychotic drugs, but about a third of the cases of Tardive Dyskinesia are linked to Reglan (metoclopramide).
An estimated two million people take metocloopramide, including children and infants. While it is approved to treat conditions such as severe heartburn, gastroesophageal reflux disease (GERD) and gastroparesis, or the delayed emptying of stomach contents, it also has an off-label use in the treatment of migraine headaches and morning sickness in women who are pregnant.
The makers of Reglan and generic versions of the drug are now facing numerous lawsuits from people like August, who are suffering permanent disability because of the drug. The Macalusoes allege they were never appropriately warned of the risk of developing Tardive Dyskinesia, and now it’s too late.
Source: News Observer
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