Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

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.

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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.

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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.

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The new health care reform bill gives senior citizens a rebate to purchase prescription medications; however, increasing availability of drugs for seniors may cause safety concerns, especially when it comes to generic versions of medication, according to a Huffington Post blog by Edward F. Blizzard.

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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.”

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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 at Texas Tech University, called it a very powerful anti-nausea, anti-vomiting tool. For Mary, it was a glimmer of hope. “Even if my symptoms got 50 percent better, it would be a huge change in my day,” she said. 

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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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