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Reglan Side Effects FAQ

What is Reglan?

Reglan, known generically as metoclopramide, is approved by the US Food and Drug Administration (FDA) for the treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) and Diabetic Gastroparesis. It is also used to treat nausea caused or brought on by cancer chemotherapy treatment. Reglan is not approved—that is, Reglan is considered "off-label"—for treatment of pregnancy-related nausea, morning sickness, lactation stimulation, and nausea brought on by migraine headache. Reglan is sometimes prescribed for regurgitation conditions in infants and children.

Reglan works by speeding up movement of the stomach muscles, increasing the rate at which the contents of the stomach are emptied into the intestines. It is available in tablets, syrups and injections.

Why is Reglan involved in lawsuits?

Reglan has been linked to the development of tardive dyskinesia and received a black box warning about the risk of tardive dyskinesia in 2009. It has been alleged that the risk of tardive dyskinesia, particularly with longer-term use of Reglan, was not publicized enough to allow patients to fully know and understand the risk of tardive dyskinesia.

How long should Reglan be used?

Reglan is approved for use of up to 12 weeks. It is not approved for use of any longer than that. According to the US FDA, patients who have taken Reglan for longer than the recommended period are at an increased risk of developing tardive dyskinesia.

What is tardive dyskinesia? What are the symptoms of tardive dyskinesia?

Patients with tardive dyskinesia experience involuntary, repetitive movements—movements that cannot be controlled. The involuntary movements can include facial "ticks" or gestures such as grimacing, tongue protrusion, lip smacking, puckering or pursing of the lips, rapid eye blinking; they can also include bodily movements such as those affecting the fingers, hands, arms, legs, shoulders—or even the torso. The effects of tardive dyskinesia can impact the ability to breathe, talk and swallow. Tardive dyskinesia is a very serious condition that can only be identified and diagnosed by a physician.

How is Reglan linked to tardive dyskinesia?

According to the FDA (02/26/09), published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders.

Has Reglan been recalled?

No, Reglan has not been recalled. In February 2009, the FDA announced Reglan would carry a black box warning, alerting patients and physicians to the risk of tardive dyskinesia when Reglan is used for longer than 12 weeks.

Can tardive dyskinesia be cured?

No. Although some patients have reported a lessening of the symptoms of tardive dyskinesia after discontinuing Reglan, there is no known cure for the condition.

Does Reglan have other side effects?

Reglan has also been linked to a condition known as neuroleptic malignant syndrome (NMS), a potentially fatal condition. Symptoms of NMS include high fever, unstable blood pressure, sweating, stupor and muscular rigidity. Symptoms of NMS can appear as early as within two weeks of starting a medication.

What should I do if I am taking Reglan now?

As with any prescribed medication, you should speak with your doctor about why you are taking Reglan and what alternative medications may be available for your specific condition, the length and dosage of your Reglan prescription, and the benefits of taking Reglan vs. the risks that may be involved.

What should I do if I, or someone I know, have been affected by taking Reglan?

Because the potential side effects of Reglan can be both serious and irreversible, the costs involved with treatment can be substantial. It is recommended that you have a lawyer review the details of your case as you may qualify for an award.
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Last updated on Apr-8-11

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