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Reglan (metoclopramide) is a prescription drug often prescribed to treat gastrointestinal problems in children and adults. Reglan is most often used to control gastroesophageal reflux disease (GERD), or to reduce nausea and vomiting. Physicians will often use Reglan for both children and adults suffering from reflux, gastroparesis, and other conditions related to the stomach such as heartburn, decreased appetite, and prolonged fullness after eating.

Reglan works by affecting the lower esophageal sphincter pressure, which then helps to improve gastrointestinal emptying. The FDA has only approved Reglan for short-term treatment (between 4 and 12 weeks) of these conditions, and only after conservative methods of treatment have failed. Unfortunately, prescription trends prove that many patients are prescribed Reglan for longer than 12 weeks (often for years), which is against FDA recommendations. We believe the manufacturers of Reglan are well aware of these extended prescription trends.

If you have been taking Reglan (metoclopramide) for over 12 weeks you are at risk of, or have been diagnosed with Tardive Dyskinesia, our lawyers can help you seek to hold the negligent party or parties liable for their actions.

Side Effects:

REGLAN (metoclopramide) can cause Tardive Dyskinesia, a serious and often irreversible movement disorder list of signs and symptoms include:

Jaw movements
Chewing-like movements 
Facial grimacing
Tongue movements
Tongue protrusion
Lip movements
Lip smacking
Lip puckering
Lip pursing
Rapid eye blinking
Rapid movements of the arms, legs, and trunk.
Involuntary finger movements
Involuntary facial movements
Abnormal facial movements
Grimacing
Sticking out tongue
Sucking of the lips
Smacking of the lips
Involuntary rapid arm movements
Involuntary rapid leg movements

 

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Other Serious Side Effects:

Mental depression
Other types of severe movement disorders
Unexplained abdominal pain
Breathing problems
Convulsions and seizures
Cardiovascular conditions, such as elevated blood pressure or rapid pulse
Blood problems, especially for infants
An allergic reaction, such as swelling of the tongue, throat or hives
Anxiety or insomnia
Depression
Changes in vision
An irregular heartbeat
Seizures or hallucinations

 

In some established cases of Tardive Dyskinesia, Reglan (Metoclopramide) been shown to mask the signs and not become apparent until discontinuation of the Drug.

Treatment Options

There is no known treatment for established cases of Tardive Dyskinesia. Those diagnosed with Tardive Dyskinesia may have a lifelong battle.

In some cases it has been shown to mask the signs and not become apparent until discontinuation of the Drug. The effect of this symptomatic suppression upon the long-term course of the syndrome is unknown. Therefore, the use of metoclopramide for the symptomatic control of Tardive Dyskinesia is not recommended.

Even when Reglan (Metoclopramide) is stopped, the patient should not assume they will recover. Symptoms of Tardive Dyskinesia can be permanent. There are drugs that can be prescribed to treat Tardive Dyskinesia, but these drugs have their own risks and side effects, and they cannot cure the condition, but only limit the symptoms somewhat.

FDA News

FDA Requires Boxed Warning and Risk Mitigation Strategy for 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.

Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or online at: www.fda.gov/medwatch/report.htm

If it begins to appear, possibly with involuntary tongue movements one of the first indicators, the medication should be immediately stopped. This may mean that the syndrome goes away, in any case, the person should be closely monitored.

People that have been on antipsychotic medication for a long time, people on high doses of antipsychotics (particularly older people), and people who have recently stopped taking antipsychotic medication.