From the FDA Drug Label
ADVERSE REACTIONS The most common is transient drowsiness (10% to 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. WARNINGS b. Abrupt Drug Withdrawal:Hallucinations and seizures have occurred on abrupt withdrawal of baclofen Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
The long-term safety of baclofen is not directly addressed in the provided drug labels. However, Abrupt Drug Withdrawal warnings suggest that long-term use may lead to dependence, and Adverse Reactions listed may persist or worsen with prolonged use 1, 1.
- Key concerns include the potential for dependence and withdrawal symptoms.
- Caution is advised when considering long-term use, and slow dose reduction is recommended when discontinuing the drug.
From the Research
Introduction to Baclofen Safety
Baclofen, a GABA receptor agonist, is commonly used to treat spasticity. The safety of long-term use of baclofen is a concern for healthcare providers.
Efficacy and Safety of Long-Term Baclofen Use
Studies have shown that intrathecal baclofen is an effective treatment for spinal spasticity that has not responded to oral baclofen 2, 3. The treatment has been found to reduce muscle tone and spasms, and improve functional outcomes. However, the risk of side effects, such as excessive hypotonia or central depression, stresses the necessity for accurate determination of the efficient dose.
Potential Risks and Side Effects
Long-term use of baclofen has been associated with potential risks, including:
- Motor unit weakness and fatigue 4
- Reduced muscle tone and spasms, but also potential for excessive hypotonia or central depression 2, 3
- Overdose can result in severe respiratory depression, autonomic disturbances, seizures, and coma 5
Treatment Considerations
When considering long-term baclofen use, healthcare providers should:
- Accurately determine the efficient dose to minimize the risk of side effects
- Monitor patients closely for signs of overdose or adverse effects
- Consider the potential long-term effects on muscle rehabilitation and function
- Weigh the benefits of baclofen treatment against the potential risks and consider alternative treatment options
Special Considerations for Specific Populations
In children with cerebral palsy, intrathecal baclofen has been found to reduce spasticity and improve comfort and ease of care, but more reliable evidence is needed to determine its effectiveness in improving gross motor function and quality of life 6.
Conclusion
Long-term use of baclofen can be safe and effective for treating spasticity, but healthcare providers must be aware of the potential risks and take steps to minimize them. Accurate dosing, close monitoring, and consideration of alternative treatment options are essential to ensuring the safe and effective use of baclofen.