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Reglan: Another Drug with Side Effects that Far Outweigh Its Benefits

Apr 1, 2010

Reglan: Another Drug with Side Effects that Far Outweigh Its Benefits

While FDA approval allows a drug to be sold in the U.S., one in five new drugs has serious side effects that do not show up until well after such approval. This often results from two serious flaws in the current “fast track” or “accelerated” approval process, namely, the lack of longitudinal (long-term) testing and the use of test groups which are far too small to represent an accurate sampling of the true range of patients who are likely to take the drugs being tested.

The removal of a drug from the market is based on the level of risks associated with the drug, the availability of alternative treatments, and the nature of the illness that the drug is intended to treat. Robert Temple, director of the office of medical policy in the FDA’s drug center says the FDA tolerates “gross toxicities for cancer and AIDS drugs that [they] wouldn’t tolerate for an antihistamine.”

Reglan is one of those drugs whose benefits hardly seem to be worth the serious risks that have now been associated with it.

Reglan (generic name metaclopromide) is used to treat heartburn caused by gastroesophageal reflux disease (GERD) as well as slow gastric emptying in diabetics. The drug can be administered by IV infusion, intramuscular injection, in a syrup, and by 5 and 10 milligram tablets.

It is intended to be taken on a short term basis only (4-12 weeks) and is designed to decrease the reflux of stomach acid by stimulating and strengthening the muscles of the gastrointestinal tract, including the muscles of the lower esophageal sphincter, stomach, and small intestine thereby decreasing heartburn and damage to the esophagus as well as hastening the emptying of solid and liquid meals from the stomach and into the intestines.

Reglan has several recognized side effects, the most serious of which is tardive dyskinesia; an often irreversible disorder that causes repetitive, involuntary movements in the body such as facial tics; involuntary movements of the extremities; smacking, pursing, and puckering of the lips; scowling or frowning; sticking out of the tongue; rapid eye movement and blinking; and restless leg syndrome (RLS).

Although the FDA received 87 reports linking metoclopramide to tardive dyskinesia from 1980 through June 2003, these may be only a small fraction of the actual number of cases since the FDA estimates only about 10% of serious adverse reactions are ever reported to the agency.

The reported cases were mainly in women with an average age of 60 who had taken an average daily dose of 33mg (within the recommended dosage). The average duration of treatment was approximately two years. In these cases, the drug was most often prescribed for heartburn (30%), followed by diabetic gastroparesis (14%), and nausea and/or vomiting (12%).

The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase with the length of treatment and the total cumulative dose of metoclopramide. There is no known treatment or cure for tardive dyskinesia.

Since the number of prescriptions for metoclopramide has been steadily increasing (5.6 million in 2004) since cisapride (PROPULSID), also a heartburn drug, was pulled from the market in March 2000, after being associated with fatal heart rhythm disturbances, the possibility of metoclopramide-induced movement disorders, especially tardive dyskinesia, is of great concern to the FDA.

The FDA recently ordered a “Black Box Warning” concerning the risk of tardive dyskinesia to be added to Reglan products. This followed a California court decision in which the plaintiff developed tardive dyskinesia after taking generic versions of Reglan. Reglan was originally developed by Wyeth and, although the drug has since gone generic, Wyeth has been sued under the theory that the pharmaceutical giant and its sales representatives were aware of and encouraged long-term treatment with Reglan in patients with chronic conditions. According to these lawsuits, the drug was promoted in this manner even though the FDA had not approved the long-term use of Reglan, and despite the lack of safety data to support such uses.

Chief of the Center for Drug Evaluation and Research (CDER) Janet Woodcock says, “The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”

If you or a loved one has suffered any adverse reaction to Reglan or metoclopramide, do not hesitate to contact us at www.yourlawyer.com, 1-800-YOUR LAWYER, or1-888-BIG-CASE, for a free consultation.

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