What is the maximum duration for taking metoclopramide (Metoclopramide) controlled release formulation before it is no longer safe?

From the Guidelines

Metoclopramide controlled release formulation should not be used for longer than 12 weeks due to the risk of serious adverse effects, including extrapyramidal signs and tardive dyskinesia, as recommended by the FDA 1. The recommended duration of use is typically between 4-12 weeks, depending on the individual's specific condition and response to treatment.

• The medication works by blocking dopamine receptors, which helps increase gut motility and reduces nausea, but prolonged blockade of these receptors can lead to movement disorders.
• Short-term use minimizes this risk while still providing therapeutic benefit for conditions like gastroparesis.
• If symptom management is required beyond 12 weeks, a healthcare provider should reassess the condition and consider alternative treatments, such as domperidone or erythromycin, which may be effective for short-term use 1.
• It is essential to take metoclopramide exactly as prescribed and report any unusual movements, muscle stiffness, or tremors to a doctor immediately, as these could be early signs of tardive dyskinesia.
• The use of metoclopramide should be reserved for severe cases that are unresponsive to other therapies, due to the risk of serious adverse effects 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Metoclopramide Controlled Release Formulation Safety

• The safety of metoclopramide controlled release formulation is a concern due to the risk of tardive dyskinesia, a movement disorder that may be irreversible 2, 3, 4, 5, 6.
• Regulatory authorities have issued restrictions and recommendations regarding long-term use of the drug at oral doses exceeding 10 mg 3-4 times daily because of the risk for development of tardive dyskinesia 2.
• The risk of tardive dyskinesia from metoclopramide is low, in the range of 0.1% per 1000 patient years, which is far below a previously estimated 1%-10% risk suggested in treatment guidelines by regulatory authorities 2.
• High-risk groups for tardive dyskinesia include elderly females, diabetics, patients with liver or kidney failure, and patients with concomitant antipsychotic drug therapy, which reduces the threshold for neurological complications 2.

Duration of Safe Use

• Metoclopramide carries a black box warning for use >12 weeks due to the risk of tardive dyskinesia 3.
• The FDA has placed a black-box warning on metoclopramide because of the risk of related side effects, including tardive dyskinesia, with an incidence cited to be as high as 15% in the literature 4.
• Analysis of the FDA Adverse Event Reporting System (FAERS) database revealed that tardive dyskinesia is one of the most reported adverse drug reactions (ADRs) associated with metoclopramide use 5.
• Available data show that the risk of tardive dyskinesia from metoclopramide use is likely to be <1%, much less than the estimated 1-10% risk previously suggested in national guidelines 6.

Key Considerations

• The risk of tardive dyskinesia and the influence of known risk factors should be considered when starting a course of metoclopramide for treatment of gastroparesis 2.
• Physicians and patients should be aware of the potential risks and benefits of metoclopramide use, particularly for prolonged treatments 3.
• Further study is needed to define the benefit-risk ratio of metoclopramide use, particularly in high-risk groups and with long-term use 6.