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

Researchers from the North Alabama Research Center based in Athens, Ala., are looking for people to participate in clinical trials for a potential new medication to treat gastrointestinal disease, also known as GERD. Persons age 18 to 70 who are still suffering from symptoms of GERD despite treatment with prescription medications are welcome to participate in the clinical trial. Participants must live within 50 miles of the clinic. Those interested can sign up at the Clinical Connection Web site here.

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Sufferers of gastroesophageal reflux disease, also known as GERD, often experience symptoms such as heartburn and a sour taste in the mouth. But nearly half of all people with GERD have no symptoms except a chronic cough.

Most people dismiss the idea that they even have the acid reflux condition because they have none of the classic symptoms, but many sufferers of chronic cough may find relief when treating themselves for GERD.

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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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Metoclopramide, known by the brand name Reglan, is one of the leading medications prescribed to treat gastroesophageal reflux disease (GERD) and gastroparesis, a condition in which the stomach takes too long to empty its contents. What many don’t know is that metoclopramide was first used to treat psychosis in patients, but it was found to show more promise as a drug to treat gastrointestinal disorders. Unfortunately, like many medications used to treat psychosis, metoclopramide also increased one’s risk of developing a severe movement disorder known as Tardive Dyskinesia.

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The U.S. Fifth Circuit Court of Appeals has found in favor with a lower court that patients may sue generic drug makers under state law for failing to provide adequate warnings about potential side effects with their drugs. The ruling extends a 2009 U.S. Supreme Court ruling governing makers of name-brand drugs. The issue of whether generic drug companies should be held liable for not adequately warning consumers has divided several district courts, which can increase the odds of a Supreme Court review in the future, according to U.S. Circuit Judge Patrick Higginbotham.

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An estimated 250,000 to 400,000 people in the United States suffer from Tardive Dyskinesia, a serious and disabling involuntary movement disorder. The condition was first linked to use of anti-psychotic medications but most recently has been linked to a common heartburn, GERD (gastroesophageal reflux disease) and gastroparesis medication known as Reglan (metoclopramide). How the medications cause Tardive Dyskinesia is debatable, but studies show that long-term use of medications leave users at higher risk of developing the condition.

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More and more doctors are diagnosing fussy infants with gastroesophageal reflux disease, or GERD, leaving some critics worrying that doctors are over-diagnosing the condition to soothe exasperated mothers.

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The Gastroparesis Awareness Campaign Organization has released a video to help raise awareness of the seriousness of the condition in which the stomach takes too long to digest food. The video, called The Faces of Gastroparesis 2009, can be seen on YouTube, and here:

People of all ages, shapes and sizes suffer from gastroparesis. The National Institutes of Health estimates as many as 10 million people are living with gastroparesis. Because of the lack of medical education and improper diagnosis, many more may be suffering in silence. Symptoms include abdominal cramps, nausea and vomiting and can result in dehydration, electrolyte imbalances and malnutrition.

Treatments include medication, such as Reglan (metoclopramide), and surgery. Those with gastroparesis suffered yet another blow this year when the Food and Drug Administration (FDA) issued a black box warning on Reglan after numerous cases of a serious movement disorder known as Tardive Dyskinesia were reported in patients who took Reglan. Long-term users were as much as 20 percent at risk of developing the condition.

Because treatments offer only temporary benefits to patients, activists groups such as the Gastroparesis Awareness Campaign Organization are working to raise awareness in hopes of finding better, safer treatments and, eventually, a cure.

Last month, a 12-year-old girl’s mysterious sneezing illness promoted a flurry of attention after her story was told on MSNBC’s Today show. Lauren Johnson sneezes 10 times a minute – up to 12,000 of times a day – and doctors have no clue why. Weeks later she was diagnosed with Paediatric Autoimmune Neuropsychiatric Disorder Associated with Streptoccus, or PANDAS. Her parents say that antibiotics have improved her disorder, but that she is at risk of showing symptoms again in the future.

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The Food and Drug Administration (FDA) has approved a generic version of a drug for treating gastroesophageal reflux disease, or GERD, in adolescents and adults. Amneal Pharmaceuticals’ nizatidine oral solution was approved in the 15-mg-per-15-ml strength, and is a generic version of Axid, made by Braintree Laboratories. The medication belongs to a class of drugs known as histamine H2 blockers.

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