Reglan Linked to Tardive Dyskinesia and Birth Defects. FDA Warns Against Chronic Use.

For individuals who have heartburn, finding a medicine that works is at the top of their priority list. Over twenty years ago Reglan (metoclopramide) was released and seemed to solve all heartburn issues until serious side-effects were reported in 2009.

Reglan is intended for short-term use amongst patients who have heartburn and esophagitis due to gas reflux disease. The drug is also used for treating impaired function of muscles of the small intestine that may give rise to symptoms such as nausea, vomiting, and abdominal distention. Lastly, Reglan is also used in the treatment of nausea due to surgery or cancer chemotherapy.

According to MedicineNet, in patients with gas reflux disease, a weakened lower esophageal sphincter allows reflux of stomach acid into the esophagus, causing heartburn and damage to the esophagus. Metoclopramide decreases the reflux of stomach acid by strengthening the muscle of the lower esophageal sphincter. Metoclopramide also stimulates the muscles of the stomach and thereby quickens the emptying of solid and liquid meals from the stomach into the intestines. The usual dose of metoclopramide for treating gas reflux is 10-15 mg four times daily, 30 minutes before each meal.

While the FDA has approved Reglan only for short-term use, many patients are being prescribed the medication for 12 months or greater. In February of 2009, the Food and Drug Administration (FDA) tied its black-box warning to Reglan and other metoclopramide-containing drugs due to the risk of tardive dyskinesia for people who take the drug in high doses or over a prolonged period. Tardive Dyskinesia is a form of dyskinesia, which causes repetitive movements, such as lip smacking, rapid eye blinking, and tongue protrusion, and tends to have a slow onset. These symptoms are rarely reversible and there are no effective treatments, but symptom management, for patients suffering with this disorder.

Black Box Warning for Gastrointestinal Drug Reglan

The U.S. Food and Drug Administration has directed that makers of the drug metoclopramide must put the strongest black-box warning on the drug known as Reglan, Octamide and Maxolon. The drug is used for gastrointestinal problems. According to reports, the drug can cause severe birth defects and/or a very serious neurological disorder known as tardive dyskinesia (TD).

About Tardive Dyskinesia

Tardive dyskinesia is a tongue, mouth and jaw disorder in which eye-blinking and face and body jerking can occur, along with difficulty swallowing. The uncontrolled body movements can be constant, according to leading neurologists. Tardive dyskinesia can persist for years and may be permanent. Severity can vary, Bronstein says. "Some people can get so bad it's hard for them to eat and swallow because of their tongue movements. And obviously, cosmetically, it's horrible."

Tardive dyskinesia occurs as a side effect of drugs that block dopamine. Once diagnosed, patients are usually taken off the drug. "In some patients, the symptoms get better," says Dr. Joseph Jankovic, a neurologist at Baylor College of Medicine in Houston. "But in many cases, it becomes a permanent neurological disorder." No standard therapy exists, but various drugs have been used as treatments.

Regland or Metoclopramide, has generally been prescribed by internists or gastroenterologists who may not be looking for the symptoms of tardive dyskinesia.

Reglan linked to Tardive Dyskenia

A recent study analyzed 443 tardive dyskinesia patients seen over 25 years at a Baylor University clinic. The studies suggest that since 2000, many of the patients who have Reglan or metoclopramide-induced movement disorders "aren't recognized until . . . they're at pretty advanced stages of the disease."

According to the recent study, the primary method of limiting risk is by limiting how long Reglan is used. Reglan is already labeled for short-term use, defined as four to twelve weeks. However, a 2007 FDA study found that 20% of medical patients were prescribed Reglan for longer term use.

The recent studies led the FDA's decision to require a black box warning, which is designed to alert physicians to serious potential dangers associated with Reglan use. Rita Chappelle of the FDA said, "We've known for years that tardive dyskinesia was a concern with this drug, but what we're trying to highlight in the box is the risk of chronic use."

Reglan Linked To Birth Defects

While Reglan (metoclopramide) has been linked to severe side effects such as Tardive Dyskenia, new studies show an increased connection between the prolonged use of Reglan and birth defects. In a study entitled "The Safety Of Metoclopramide Use In The First Trimester of Pregnancy," and published in June 2009 in the New England Journal of Medicine, 81,703 babies were surveyed. Of these babies, 3,458 were born to mothers taking metoclopramide products to relieve symptoms related to morning sickness. The study found that of the 4,016 babies born with birth defects, 65% came from mothers who used Reglan beyond their first trimester.

Reglan is only approved in the United States by the FDA for the short-term treatment of gastrointestinal disorders like diabetic gastroparesis, gastroesphageal flux (GERD) and delayed gastric emptying.

If you or a loved one have experienced repetitive and involuntary muscle or facial movements, or been diagnosed with tardive dyskinesia following Reglan use, please contact us for a free case review.

FDA News

February 26, 2009: FDA Requires Boxed Warning and Risk Mitigation Strategy for Reglan and Metoclopramide-Containing Drugs
Agency warns against chronic use of these products to treat gastrointestinal disorders

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.

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

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach's contents into the intestines). It is recommended that treatment not exceed three months.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months. (Source: FDA)

If you or a loved one have experienced repetitive and involuntary muscle or facial movements, or been diagnosed with tardive dyskinesia following Reglan use, please contact us for a free case review.