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Why Reglan Caught The Attention Of The FDA

By: Nick Messe


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Reglan (Metoclopramide) is an antiemetic drug that is used to treat nausea and problems with the gastrointestinal tract. It is meant to prevent episodes of nausea and vomiting in patients with stomach disorders. It also helps to induce the contractions of the stomach to push the food into the intestines.

A doctor might prescribe Reglan for the prevention or treatment of nausea, motion sickness, acid reflux, and sickness caused by radiation therapy. Migraine headaches also show improvement when treated with Reglan. When used in combination with another drug it has been also shown to promote lactation.

Diarrhea, constipation, depression, dizziness, drowsiness, restlessness, and headaches are all some of the lesser side effects of Reglan. What caught the attention of the FDA was the reports of unusual side effects from the use of Reglan that were previously unknown. Patients taking the drug for extended periods reported symptoms of involuntary muscle movements. The condition known as Tardive Dyskinesia, a neurological disorder, has been linked to chronic use of Reglan.

In most of these severe cases the drug was used consistently for three months or more. This condition causes involuntary muscle movements of the face, jaw, neck, shoulders, arms, legs and feet. Facial ticks, muscle jerks, repetitive chewing, rapid eye movements, loss of bladder control, and symptoms similar to Parkinson's Disease have been reported wide scale. These side effects continue long after stopping use of the drug and appear to be irreversible. There have even been a few hinted reports of suicide.

The U.S. Food and Drug Administration has since issued a Black Box Warning. This means that the drug manufacturer must include a warning label on all drugs that contain metoclopramide. Doctors have been advised to prescribe this drug only as a last resort and for as short a time as possible. The Black Box Warning is the strongest warning issued by the FDA.

All packages of Reglan and other drugs containing Metoclopramide will now carry a new warning label warning about the possibility of developing a neurological disorder from taking this medicine. Previously the only warning on the labeling was a letter directed to the doctor outlining minor side effects only.

In May of 2009 several patients diagnosed with Tardive Dyskinesia joined a class action suit against the manufacturers of Reglan. These patients had been diagnosed with this condition after using Reglan. Cases of Tardive Dyskinesia has been reported in other countries that approved use of this drug as well. Several states including Louisiana, Georgia and Alabama have lawsuits pending against Baxter Pharmaceutical .

Reglan attorneys are urging anyone who has developed this condition after using the drug to contact them and join the class action suit. The attorney are offering a free evaluation to anyone who feels that he or she may qualify to join this suit. The Reglan lawyers contend that the manufacturer knew about the serious condition and that doctors and patients were not adequately informed of the dangers of long term use of this drug.

Article Source: http://depositarticles.com/

Nick Messe is the founder and president of Lead Frog LLC. If you or a loved one has taken Reglan and developed tardive dyskinesia you should contact a Reglan lawyer to learn about possible financial compensation - www.reglanadvice.com

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