Should liver function be monitored in patients taking terbinafine (Lamisil)?

From the Guidelines

Yes, liver function should be monitored when a patient is taking terbinafine, especially in those with a history of heavy alcohol consumption, hepatitis, or haematological abnormalities, as recommended by the British Association of Dermatologists' guidelines for the management of onychomycosis 2014 1.

Key Considerations

• Baseline liver function tests (LFTs) should be obtained before starting terbinafine therapy, as suggested in the guidelines 1.
• Periodic monitoring of LFTs is recommended, typically at 4-6 week intervals, to identify early signs of liver injury.
• Patients should be educated to report symptoms such as persistent nausea, decreased appetite, fatigue, right upper quadrant pain, dark urine, or jaundice immediately.
• Those with pre-existing liver disease or who consume significant amounts of alcohol may be at higher risk for hepatotoxicity and require more careful monitoring.

Monitoring and Management

• If significant LFT abnormalities develop (typically ALT or AST greater than 3 times the upper limit of normal), terbinafine should be discontinued, as recommended in the guidelines 1.
• The risk of hepatotoxicity appears to be idiosyncratic rather than dose-dependent, and monitoring helps identify early signs of liver injury before they progress to more serious complications.

Special Considerations

• Terbinafine is not recommended in patients with active or chronic liver disease, as stated in the guidelines 1.
• Baseline monitoring should also be considered for children, as terbinafine is not licensed for use in treating paediatric onychomycosis, as noted in the guidelines for children 1.

From the FDA Drug Label

Before prescribing terbinafine tablets, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Periodic monitoring of liver function tests is recommended. Treatment with terbinafine tablets should be discontinued if biochemical or clinical evidence of liver injury develops. Measurement of serum transaminases (ALT and AST) is advised for all patients before taking terbinafine tablets.

Yes, you should monitor liver function on terbinafine. Key points to consider:

• Perform liver function tests before prescribing terbinafine
• Periodically monitor liver function tests during treatment
• Discontinue treatment if liver injury is suspected 2

From the Research

Liver Function Monitoring on Terbinafine

• The need for liver function monitoring on terbinafine is supported by several studies, including 3 and 4, which highlight the risk of hepatotoxicity associated with terbinafine use.
• A study published in the BMJ case reports 3 recommends monitoring of liver function tests during terbinafine treatment, especially in patients with pre-existing liver disease.
• Another study published in the International journal of clinical pharmacy 4 suggests that liver function assessment before treatment and periodic monitoring 4-6 weeks after initiation of treatment is recommended.

Recommendations for Liver Function Monitoring

• The British journal of dermatology 5 suggests that patients should be advised to discontinue treatment and seek medical care when symptoms of liver injury occur, rather than relying on laboratory monitoring.
• However, a more recent study published in Expert opinion on drug safety 6 recommends laboratory testing of liver function tests prior to the administration of any oral antifungals, especially when clinically indicated.
• The same study 6 also recommends consideration of antifungal susceptibility testing in the event of a first treatment failure, and emphasizes the importance of antifungal stewardship to reduce the incidence of antifungal resistance.

Key Findings

• Terbinafine has been associated with severe acute liver injury, although this is a rare complication 4.
• The prognosis for patients with terbinafine-induced liver injury is often good with appropriate treatment 4.
• Patients who experience symptoms of liver injury, such as jaundice, abdominal pain, and general malaise, should seek medical attention promptly 5.