Metoclopramide

Frequently Asked Questions about metoclopramide (Reglan, Octamide, Maxolon)

What is Tardive Dyskinesia?
Tardive Dyskinesia (“TD”) is a serious neurological disorder, characterized by uncontrollable, involuntary body movements such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers, as though the patient were playing an invisible piano. The movements are not controllable, and they are continuous, stopping only when the person sleeps. Tardive Dyskinesia may persist for months, even years after the medication has been discontinued, and is usually not reversible.

Is there any treatment for Tardive Dyskinesia?
There is no known treatment for TD. The majority of people who develop TD continue to have symptoms for the rest of their lives.

What is metoclopramide?
Metoclopramide, marketed as Reglan, Octamide, and Maxolon, is a drug which increases the stomach’s ability to empty digested food and move it on to the small intestine. Slowed stomach-emptying sometimes becomes a problem in diabetes, and many users of metoclopramide (Reglan, Octamide, Maxolon) are diabetics. Other uses include treatment of heartburn in gastroesophageal reflux when first-line drugs have not worked, and management of nausea and vomiting in migraines and in cancer treatment.

What is known about metoclopramide and Tardive Dyskinesia?
In the FDA’s recent announcement, it acknowledged that it had received numerous reports of patients who had been on metoclopramide (Reglan, Octamide, Maxolon) for more than twelve weeks who then developed Tardive Dyskinesia.

How should metoclopramide be used?
Prescribing literature has always recommended that metoclopramide should be used for no more than twelve weeks, because increased use and higher dosages exposes the patient to greater risk of developing TD.

Are patients kept on metoclopramide for longer than the recommended time?
The FDA cited a study in which 20% of patients were maintained on metoclopramide for longer than three months.

How should metoclopramide be used?
Prescribing literature has always recommended that metoclopramide should be used for no more than twelve weeks, because increased use and higher dosages exposes the patient to greater risk of developing TD.

Are there alternatives to using metoclopramide?
There are other anti-nausea drugs and other drugs which can assist with slow stomach emptying. Patients should consult their doctor about alternatives.

What should I do if I or a loved one has used metoclopramide and developed TD?
You should immediately notify your prescribing physician, and be guided by your physician’s advice.

If I have developed TD, do I have a legal case?
You will need to consult an experienced pharmaceutical and dangerous drug attorney for an individualized evaluation of your situation.