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

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.

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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.

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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.

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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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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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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.

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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 various antibiotics to enhance GI mobility and prevent severe bacterial overgrowth in various GI motility disease,” usage deemed worthy by many who suffer from GI disorders.

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In the February 1996 issue of the drug newsletter Worst Pills, Best Pills News, a story was published by the Health Research Group of Public Citizen warning that a drug commonly prescribed for heartburn and slow emptying of the stomach contents, a condition known as gastroparesis, could cause a serious movement disorder known as Tardive Dyskinesia. The condition could cause permanent disability in users, according to the report.

However, it took more than a decade for the Food and Drug Administration (FDA) to place a black box warning on the medication, Reglan. A black box warning is the strongest warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. Meanwhile, the drug was dispensed 6.5 million times in 2008 to an estimated 2 million Americans.

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