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A new medication may soon be available for patients who suffer from advanced gastroparesis, or delayed emptying of the stomach contents. Tranzyme Pharma is presenting data on its experimental drug ulimorelin later this month at the 2010 Joint International Meeting in Neurogastroenterology and Motility in Boston, Mass.
Wendy from Oklahoma sought advice from fellow gastroparesis sufferers on Inspire.com’s group forum after her doctor recommended she take Reglan (metoclopramide) to treat symptoms of her condition. Gastropareses causes pain and nausea from slow emptying of the stomach contents. Wendy was concerned, she said, because “I read (Reglan) was the leading prescription cause for tardive dyskinesia,” a debilitating involuntary movement disorder similar to Parkinson’s.
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.
Tranzyme Pharama says its new treatment for diabetic gastroparesis, a disabling disorder in which the stomach takes too long to empty its contents, has shown positive results in phase II clinical trials among diabetic patients with the digestive disorder. The pharmaceutical company was granted “fast-track status” by the Food and Drug Administration (FDA) for TZP-102, a designation that is typically reserved for drugs that treat serious and unmet medical needs. The designation is designed to speed up the review and approval process.
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.
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 study has found that quality improvement intervention initiatives such as ongoing education and automated feedback reports of medication usage among low birth weight babies in neonatal intensive care units (NICU) can significantly reduce use of medications, some of which carry serious adverse effects.
For nine years, Valerie (not her real name) was prescribed and took Reglan (metoclopramide) to control her acid reflux. The drug was approved by the Food and Drug Administration (FDA) in the 1980s to treat various digestive tract conditions such as severe heartburn and gastroparesis, or the delayed emptying of the stomach contents. As the drug became more widely prescribed, the FDA began receiving reports that the drug may cause a neurological disorder. Despite the warning signs, it took the FDA almost 30 years to investigate and act.
Salix Pharmaceuticals stock rose 5 percent last week despite news that the company received a warning letter from the Food and Drug Administration (FDA) urging the company to clarify information about its new orally dissolving heartburn treatment, Metozolv ODT, according to Local Tech Wire. The FDA said that some of the drug’s marketing materials are “false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”
