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

Makers of generic drugs who do not adequately label their products to warn consumers of possible risks are not exempt from liability, according to a ruling by the U.S. Court of Appeals for the Eighth Circuit. The court ruled on a product liability lawsuit brought by Gladys Mensing, who was prescribed metoclopramide to treat diabetic gastroparesis, a debilitating condition in which the stomach empties too slowly. Following use of the medication, Mensing developed a serious movement disorder known as Tardive Dyskinesia. Research has shown that the condition can be caused by long-term use of metoclopramide. Mensing sued several makers of generic metoclopramide, known by the brand name Reglan, for not adequately warning consumers of the risk of developing the movement disorder.

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Salix Pharmaceuticals’ new gastrointestinal disorder treatment Metozolv (metoclopramide) OTC (orally disintegrating tablet ) utilizes Zydis, a fast-dissolve technology made by Catalent Pharam Solutions. Zydis is a unique, freeze-dried oral solid dosage form that can be swallowed without water because it dissolves instantly on the tongue in less than three seconds, according to Catalent. This delivery method translates to dosing convenience and ease of administration that makes taking medication easier for patients.

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An abnormal wiring in the brain may counteract genetic mutations for dystonia, and may lead to new treatment and prevention options for patients with movement disorders, according to the Journal of Neuroscience.

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Salix Pharmaceuticals, Ltd., makers of medicines for various gastrointestinal ailments, has received marketing approval from the Food and Drug Administration (FDA) for Metozolv ODT for the treatment of both diabetic gastroparesis and symptomatic documented GERD. Metozolv ODT is an orally disintegrating metoclopramide tablet. Metoclopramide was previously only available in the United States in a pill form under the brand name Reglan.

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Tranzyme Pharma’s new drug to treat diabetic gastroparesis has been granted a fast-track designation by the Food and Drug Administration (FDA), allowing it faster access to FDA personnel as it moves through the approval process. The new medication, called TZP-102,  has just moved into phase II trials in humans. If the trials run smoothly, the drug should enter phase III trials next year with approval by 2013 at the earliest. The fast-track designation is reserved for drugs that treat serious and unmet medical needs.

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People who suffer from heartburn, GERD or diabetic gastroparesis are often prescribed metoclopramide, known in the U.S. by the brand name Reglan, to treat their condition. Recent warnings issued by the Food and Drug Administration (FDA), however, may make those individuals consider natural alternatives before turning to pharmaceuticals.

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Prokinetic drugs, such as Reglan (metoclopramide) are those that increase the movement of ingested material through the gastrointestingal tract. They are usually prescribed to treat diabetic gastroparesis, heartburn and nausea and vomiting in chemotherapy patients. Unfortunately, some prokinetic drugs may produce a number of serious side effects.

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A Canadian study of pregnant Israeli women who took the heartburn medicine Reglan (metoclopramide) to treat morning sickness has shown the drug does not increase the rate of birth defects in the babies born to those women, compared with babies born to women who did not take the medication.

While researchers are calling this encouraging news to pregnant women, the U.S. Food and Drug Administration (FDA) says more studies must be conducted before the agency will grant approval for the drug to be used in the treatment of morning sickness. After all, the drug carries a black box warning to consumers and health care providers of a serious, debilitating and often irreversible movement disorder called Tardive Dyskinesia. Other problems, it appears, may occur when the medication is taken on a long-term basis, even for pregnant women. 

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The Food and Drug Administration (FDA) has accepted the complete response from Salix Pharmaceuticals for its orally disintegrating tablet (ORT) form of metoclopramide called Metozolv, and says it has granted a Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to collect fees from companies that produce certain human drug and biological products, for September 11, 2009. Salix is seeking approval for its drug in the treatment of short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal refulx (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (delayed emptying of the stomach).

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Are little Jessica’s sudden head jerks a side effect of the heartburn drug Reglan? It’s a question posed along with a video of the toddler by Fiestagrill on YouTube.

Reglan, also known as metoclopramide, is generally prescribed to treat diabetic gastroparesis in adults and gastroesophafeal reflux in adults and children. Recent clinical studies have shown that it is safe for the treatment of morning sickness in women who are pregnant. However, a recent FDA warning has made people like Fiestagrill question whether the medication is causing serious injury to babies as well as children.

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