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| Childers, Schlueter & Smith

The ugly truth about Reglan is finally beginning to surface even though its effects have been around for years. The generic name for Reglan is Metoclopramide. The drug is commonly used to treat patients suffering from gastrointestinal problems. Because more than 2 million Americans use products containing Metoclopramide, the real facts about the drug and its effects must be made known to consumers.

The Food and Drug Administration (FDA) only approved Reglan for short-term use (4-12 weeks). When Reglan is used for longer periods of time or at higher doses it can cause Tardive Dyskinesia. Those greatest at risk for developing tardive dyskinesia are the elderly, especially older women. Tardive Dyskinesia is a neurological syndrome characterized by repetitive and involuntary movements, such as lip smacking, puckering, rapid eye blinking. The disease can also cause rapid involuntary movements of the fingers, hands, arms, shoulders, torso and legs. Tardive Dyskinesia is an exhausting disease because its victims suffer from constant involuntary movements.

Unfortunately, both the manufacturer of Reglan (Wyeth Pharmaceuticals) and manufacturers of the generic metoclopramide (Actavis Elizabeth, Teva Pharmaceuticals USA, Pliva and Barr Pharmaceuticals) have placed profits before patient safety. Patients typically take Reglan for longer than 3 months because the drug treats chronic problems. Manufacturers have been well aware of these treatment trends and the fact that they go beyond FDA recommendations. Yet because Reglan is such a large money making drug, there is very little incentive for manufacturers to warn chronic users of the dangers associated with long-term use. Failing to warn consumers properly prevents them from making an informed decision about their treatment. In order to maintain profits and keep them on the rise, manufacturers have done their best to keep Tardive Dyskinesia out of the public’s awareness.

"The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment," Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s news release. "The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk."

The only reason that Tardive Dyskinesia was initially listed as a side effect on the drug’s information sheet is because the government required manufacturers to do so. However, as of February 26, 2009 the FDA now requires a “black box” warning for drugs containing metoclopramide. This warning is the strongest warning the FDA can order. The required warning highlights the risk of developing Tardive Dyskinesia with long-term or high-dose use, even after the drugs are no longer taken. In addition to the “black box” warning, manufacturers must implement a risk evaluation and mitigation strategy (REMS), which is a way to make sure patients receive a medication guide that discusses the risk of Tardive Dyskinesia.

The “black box” warning may have came too late for many consumers. Drug manufacturers have a responsibility to the public. They must determine the risks associated with a particular drug, research these risks further and then properly inform consumers and their doctors. Manufacturers of drugs containing Metoclopramide failed to research and disclose the link between their drugs and Tardive Dyskinesia. For this reason, many consumers are now pursuing a Tardive Dyskinesia lawsuit or a Reglan lawsuit due to the devastating effects and injuries they have sustained.

Our Reglan Lawyers are filing Reglan Lawsuits in Georgia and in every other state in the U.S. on behalf of those suffering from Tardive Dyskinesia and other known movement disorders. If you or a loved one has questions about your rights or any of these conditions, please contact our Reglan Attorneys now to see how we can help.

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