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Drugs & Devices > Reglan

Generic Name: Metoclopramide (meh toe KLOE pra mide)

Reglan, manufactured by A.H. Robins, has been linked to serious adverse effects such as Tardive Dyskinesia and Neuroleptic Malignant Syndrome.

What Is Reglan?

Reglan is a prescription drug that is intended for short-term use for the treatment of gastroesophageal reflux. Reglan® can also be prescribed for patients with diabetic gastroparesis – a condition that results in slow gastric emptying, and which can cause intense heartburn, nausea and vomiting.

Chronic use of Reglan has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. The use of Reglan tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration.

FDA Issues Black Box Warning For Reglan:

In February of 2009, the U.S. Food and Drug Administration announced that manufacturers of metoclopramide such as Reglan, 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.

Serious Side Effects of Reglan

If you experience any of the following serious side effects of Reglan or the generic name of Metoclopramide, seek emergency medical attention or contact your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • uncontrollable movements or spasms of your arms, legs, lips, jaw, tongue, face, or other body part;
  • anxiety, agitation, jitteriness, difficulty breathing, or insomnia;
  • depression
  • yellowing of the skin or eyes;
  • changes in vision;
  • an irregular heartbeat; or
  • seizures or hallucinations.

What is Tardive Dyskinesia?

Tardive dyskinesia is a neurological syndrome caused by the long-term use of neuroleptic drugs. Neuroleptic drugs are generally prescribed for psychiatric disorders, as well as for some gastrointestinal and neurological disorders. Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur. Involuntary movements of the fingers may appear as though the patient is playing an invisible guitar or piano.

More on Tardive Dyskinesia
The term tardive dyskinesia was introduced in 1964. Dyskinesia means "abnormal movement" and tardive means "late", signifying that the dyskinesia only occurs after some time has elapsed following initial administration of the neuroleptic drug.HWH

What causes Tardive Dyskinesia?
The cause of tardive dyskinesia appears to be related to damage — due to the use of antipsychotic medications — to the system that uses and processes the neurotransmitter dopamine. It is thought that postsynaptic dopaminergic receptors become supersensitive to stimulation during neuroleptic treatment and that this supersensitivity causes the symptoms of tardive dyskinesia.

Is there any research on Tardive Dyskinesia?
The available research seems to suggest that the concurrent prophylactic use of a neuroleptic and an antiparkinsonian drug is useless to avoid early extrapyramidal side-effects and may render the patient more sensitive to tardive dyskinesia.

Who can get Tardive dyskinesia?
Tardive dyskinesia most commonly occurs in patients with schizophrenia, bipolar disorder, or other psychiatric conditions who are given antipsychotic medication, but it can occur in other patients who are treated with these drugs. Some estimates suggest that it occurs in 15-30% of patients receiving treatment with antipsychotic neuroleptic medications for 3 months or longer. Other estimates suggest that with each year of neuroleptic use, 5% of the patients will show signs of tardive dyskinesia, i.e., 5% after one year, 10% after two years, 15% after three years with no clear upper limit. Eventually, according to these estimates, if on the drugs long enough, the majority of patients will develop the disorder. The incidence of tardive dyskinesia varies with the type of neuroleptic (e.g., haloperidol (Haldol®) more often than perphenazine (Trilafon), daily dose and duration of treatment (the higher the daily dose and the longer the duration of treatment, the higher the risk).

What patients are more sensitive to getting Tardive dyskinesia?
The elderly and female patients are more prone to develop tardive dyskinesia. Children and adolescents are much more sensitive to the early and late extrapyramidal side-effects of neuroleptics than adults. Because of this, treatment of youngsters with neuroleptics may be contraindicated, and many authorities believe that they should be initiated only as a last resort, using the lowest dose regime possible and the shortest duration of treatment in accordance with good patient management.

How severe is Tardive dyskinesia?
Tardive dyskinesia can become a thoroughly debilitating social handicap. The devastating impact of tardive dyskinesia illustrates why patients (if their condition allows) and/or their families (guardians and/or caregivers/nurses) must receive full information about the neuroleptic before starting treatment (informed consent).

Can Tardive dyskinesia be prevented?
Primary prevention of tardive dyskinesia is achieved by using the lowest effective dose of a neuroleptic for the shortest time. If tardive dyskinesia is diagnosed, the causative drug should be reduced or discontinued if possible. Tardive dyskinesia may persist after withdrawal of the 'offending neuroleptic' for months, years, or even permanently.

Is there a cure for Tardive dyskinesia?
There is no known cure for tardive dyskinesia, but preliminary research suggests that the atypical neuroleptic clozapine (Clozaril) may improve the state of the patient. Improvements are also seen in some cases, if the high potency benzodiazepines - lorazepam (Ativan), diazepam (Valium), or clonazepam (Klonopin)--are used. The findings about the effects of natural substances, such as vitamin E (Alpha-Tocopherol) or melatonin, are inconclusive.

What are the treatments for Tardive dyskinesia?
Treatment with adrenergic blocking agents and dopamine agonists like bromocriptine also remains somewhat controversial. There have been some reports of promising effects from the drug tetrabenazine (a different kind of neuroleptic). On the contrary, most antiparkinsonian drugs worsen the state of the patient.

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