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Researchers in Sacramento, Calif., are looking for people who still experience troublesome symptoms of gastroesophageal reflux disease (GERD) even while taking heartburn medication, to participate in a study to evaluate an investigational heartburn treatment.
You can’t turn on the TV these days without hearing that the heartburn medication Reglan, also known by the generic name metoclopramide, has been linked to the serious involuntary movement disorder, Tardive Dyskinesia. But the drug also carries another serious warning – it can cause depression and suicidal thoughts.
A team of researchers in India hope a new tool for identifying acid reflux disease will lead to improved treatments for the more than 15 million Americans who suffer from the bothersome symptoms. The tool is a molecular imaging device that allows researchers to study the differences between a healthy esophageal muscle and an unhealthy one.
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.
Gastroesophageal reflux disease, or GERD, affects as many as 40 percent of the population. The nagging symptoms of frequent heartburn, upset stomach and an acid taste in the back of the throat can help identify the condition. But some less common symptoms can make the diagnosis more difficult to pinpoint.
American children are taking more medications than ever before to treat chronic conditions, according to the 2010 Medco Drug Trend Report, raising the question, “How safe are these drugs for children?”
Wyeth, Inc. and Schwarz Pharma Inc. have been dismissed from a lawsuit filed in Texas involving the drug company’s Reglan (metoclopramide), a medicine used to treat gastrointestinal conditions. The lawsuit alleged that the drug caused the plaintiff to develop a severe movement disorder known as Tardive Dyskinesia. However, the case will proceed against Activis-Elizabeth, L.L.C., makers of a generic version of metoclopramide that the plaintiff was taking.
A New Jersey judge is calling for a statewide consolidation of all lawsuits filed against the makers of the heartburn medication Reglan that involve claims that the drug caused a serious and debilitating movement disorder known as Tardive Dyskinesia. Judge Eugene J. Codey, Jr., of the Essex County Superior Court, filed the request arguing that the New Jersey court system could better handle the mounting number of lawsuits if they were all centralized in one court. The primary defendant in the lawsuits, Wyeth Pharmaceuticals, is headquartered in New Jersey.
Mederi Therapeutics Inc. is launching an innovative new radiofrequency device for the treatment of gastroesophageal reflux disease, also known as GERD. Mederi’s Stretta is a balloon catheter with a needle that delivers radiofrequency energy. The system is inserted into the esophagogastric junction, or the sphincter controlling the entrance of food into the stomach, and prevents stomach acids from backing up into the esophagus. The radiofrequency waves work to restore the function of the valve separating the esophagus from the stomach.
The Food and Drug Administration (FDA) has fired off a warning letter to drug maker Salix Pharmaceuticals arguing that some of its marketing materials for Metozolv, an orally dissolving form of metoclopramide for the treatment of acid reflux conditiosn, “are false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”
The letter goes on to say that “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”
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