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gastroparesis 42 articles

Diabetic gastroparesis treatment shows well in clinical trials

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. Tranzyme Pharma’s drug candidate would be an alternative to a drug for gastroparesis that now carries a black ... Read More

Man suffers permanent disability from heartburn drug

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 ... Read More

Generic Reglan makers released from Tardive Dyskinesia lawsuit

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. Wyeth and Schwarz originally developed the brand-name metoclopramide, Reglan. They were released from litigation by U.S. District Judge Marcia A. Crone. The case is expected to be ready for trial by January 2011. ... Read More

Quality improvements reduce drug usage among neonatal community

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. Researchers with Pediatrix Medical Group analyzed data from 49,777 infants born between 2003 and 2008 with a birth weight of 501-1,500 grams – or 1 to 3 pounds. The goal of the study was to determine the effectiveness of a multi-faceted quality improvement intervention in reducing the use of many medications that have not been ... Read More

Long-term use of Reglan can cause serious neurological problems

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. In that time, more and more patients were developing a serious involuntary ... Read More

New Jersey judge calls for consolidation of Reglan lawsuits

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. In his consolidation request to the administrative director of the courts ... Read More

Gastroparesis sufferer finds relief through surgery

Surgery was all Mary Carter could hope for. The 27-year-old lover of food wanted to be able to eat again. But after a brief illness, she was unable to eat without becoming ill. She suffered from gastroparesis, a condition in which the stomach takes too long to empty its contents. It can cause serious problems for sufferers, including dehydration and malnutrition. When we first told you about Mary, she was gearing up for an innovative surgery that would place a device called the Enterra into Mary’s abdomen. Her doctor, Richard McCallum, founding chair at the Paul Foster School of Medicine ... Read More

FDA warns makers of acid reflux drug to change warning label

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 ... Read More

Woman to have innovative new surgery to treat gastroparesis

If 27-year-old Mary Carter had her wish, she would be a food critic. But instead of enjoying lavish meals in fine restaurants, she gets her nutrition through a feeding tube. Mary remembers when her life changed so dramatically. It was August 1, 2006, and she was driving in her car. She began to feel nauseous, her heart raced, and her vision became blurry. From that moment on, everything she put in her mouth she would vomit up. Mary suffers from gastroparesis, a condition in which the stomach takes too long to empty its contents. It is a debilitating condition that ... Read More

Gastroparesis group to petition Sen. McCain about criticism of IBS funding

Last December, Sen. John McCain identified Irritable Bowel Syndrome (IBS) as an illness unworthy of receiving funds for research, citing an earmarked $665,000 for the Cedar Sinai Medical Center in Los Angeles, California, for equipment and supplies to research the debilitating condition. This triggered the Gastroparesis Patient Association for Cures and Treatment (G-PACT), an organization that raises awareness of gastric mobility disorders, to write a petition to present to Sen. McCain on March 8, 2010. The petition stresses that the money is used to assist in the “funding innovating GI motility research by Cedars Sinai to study the use of ... Read More