Finally, in February of 2009, sixteen years after the heartburn drug Reglan was linked to Tardive Dyskinesia, a neurological condition, the Food and Drug Administration put a warning on the label. That was a year ago, and now in February 2010 malpractice suites are surfacing. Even though the FDA has only approved Reglan for short-term use, a third of its users are on the drug for a year or longer, classifying them as long-term users.
The drug affects a large number of people and was dispensed 6.5 million times in 2008 alone. It was first approved by the FDA in 1958 for use on heartburn. It is an anti-nausea medication also known as metoclopramide, prescribed to treat gastrointestinal disorders such as acid reflux, diabetic gatroperesis and nausea associated with chemotherapy. Reglan increases stomach and small intestine contractions and has been prescribed to children, adults and pregnant women.
Reglan stimulates the muscles of the gastrointestinal tract, the sphincter, stomach and small intestine. This causes the stomach to empty faster, and thus there is less reflux of stomach acid into the esophagus.
Patients who have taken Reglan can develop Tardive Dyskinesia. Tardive Dyskinesia is a permanently debilitating neurological condition that causes involuntary and repetitive movements of the lips, eyes, and fingers, similar to Parkinson's Disease. There is no known treatment for Tardive Dyskinesia, which permanently affects its victims physically, emotionally, and vocationally. Many people who took heartburn medication years ago and now have facial ticks, other neurological disorders may not realize they may be experiencing effects from Reglan.
Many doctors have continued to prescribe the drug simply because they are unaware of the consequences. When a physician prescribes a drug to you, this is a classic example of why it is important to do your own research and discuss possible side effects with your pharmacist. For instance, even though metoclopramide is not FDA-approved for morning sickness, many physicians prescribe it to treat pregnant women who suffer from nausea, and to increase milk production in nursing women. There is a label on Reglan which clearly states that the drug can pass into breast milk and may harm the baby.
Clearly on the Reglan label, the FDA has put a warning about using the drug longer than 12 weeks. The FDA warning does not Tardive Dyskinesia can occur even with short term use, and that the risk increases with long term use.
Many physicians may have been confused when prescribing metoclopramide because just three months after the FDA issued its warning, an article printed in the New England Journal of Medicine claimed that the drug was safe for use by pregnant women, and did not mention the risk of Tardive Dyskinesia.
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