FDA BLACK-BOX WARNING
WARNING: TARDIVE DYSKINESIA
- Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage.
- Metoclopramide should be discontinued in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after the drug is stopped.
- Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use.
Other Important Warnings for Metoclopramide
(1) In addition to tardive dyskinesia, metoclopramide may cause other neurologic movement disorder symptoms, including the following:
- Extrapyramidal symptoms (EPS), such as acute dystonic reactions (involuntary muscle contractions in head, neck or back. Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages
- Parkinson disease-like symptoms, including bradykinesia (slowness of movements), tremor, rigidity and expressionless face.
- Motor restlessness, consisting of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, and foot tapping.
(2) Metoclopramide can cause neuroleptic malignant syndrome (NMS), particularly if overdosed or taken concomitantly with other medications that cause NMS, such as antipsychotic drugs. NMS is a life-threatening neurological disorder requiring immediate medical attention. Signs and symptoms of NMS include high fever; excessive sweating; stupor (impaired consciousness and markedly decreased responsiveness); muscle rigidity or stiffness; unstable blood pressure, which may lead to dizziness and fainting upon standing; and irregular heart rate or pulse.
(3) Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal thoughts and suicide. Metoclopramide should be avoided in patients with a history of depression.
(4) Metoclopramide may increase blood pressure. The drug should be avoided in patients with hypertension or those taking monoamine oxidase inhibitors.
(5) Metoclopramide may cause fluid retention and swelling in patients with severe liver disease or heart failure.
(6) Metoclopramide increases levels of the hormone prolactin. This may lead to galactorrhea (a milky nipple discharge unrelated to the normal milk production of breast-feeding), amenorrhea (absence of menstruation), gynecomastia (breast enlargement in men), and erectile dysfunction.
(7) Metoclopramide may impair the mental or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of central nervous system depressants or drugs associated with extrapyramidal symptoms may increase this effect (for example, alcohol, benzodiazepines and opioids).
Dietary Steps to Manage Nausea Induced by Cancer Drugs
Drugs used to treat cancer often cause severe nausea and vomiting, either immediately after the drug is taken or several hours later. You can treat this kind of nausea and vomiting by changing your diet or by taking an antinausea drug. You should always try dietary changes first.
Eat small, frequent meals so that your stomach is never empty.
When you get up from sleeping or resting, eat some dry crackers or toast before you start being active.
Drink carbonated drinks or other clear liquids such as soups and gelatin.
Eat tart foods such as lemons and pickles.
Do not eat foods with strong smells.