Voriconazole: reminder of risk of liver toxicity, phototoxicity, and squamous cell carcinoma
- Medicines and Healthcare products Regulatory Agency
- 30 May 2014
- Therapeutic area:
- Infectious disease
Test liver function before and during treatment and tell patients to avoid sunlight exposure.
Article date: May 2014
Voriconazole (Vfend) is an antifungal medicine indicated for certain worsening, possibly life-threatening fungal infections in adults and children aged over 2 years. Voriconazole is known to be associated with a risk of liver toxicity, phototoxicity, and squamous cell carcinoma of the skin.
In clinical trials, some participants had serious hepatic reactions while taking voriconazole (including hepatitis and fulminant hepatic failure), some of which were fatal. Most of these reactions were in people with serious underlying medical conditions. Transient hepatic reactions (eg, jaundice, high liver enzyme levels) have occurred in people who took voriconazole but had no other risk factors. Liver function usually reverts to normal once voriconazole is stopped.
We have received 1 Yellow Card report of a hepatic disorder and 3 Yellow Card reports of skin disorders in people taking voriconazole in the past 12 months, none of which were fatal (this rate is similar to previous years).
The manufacturer is distributing tools to increase awareness and improve the monitoring and management of these risks. These include a healthcare professionals’ Q&A brochure, healthcare professionals’ checklist, and patient alert card (please see below). As with all anti-infective treatments, consider official guidance on appropriate use when prescribing voriconazole.
Advice for healthcare professionals:
The advice below applies to both adults and children taking voriconazole.
- Test liver function before starting treatment with voriconazole (specifically, aspartate transaminase [AST] and alanine transaminase [ALT] levels).
- Continue testing liver function at least weekly for the first month of treatment and monthly thereafter if there are no changes in the first month of treatment.
- Stop voriconazole if AST or ALT levels become markedly elevated, unless you consider the benefits of voriconazole treatment to outweigh the risk of liver toxicity in that individual.
Phototoxicity and squamous cell carcinoma
- Tell patients to avoid sunlight exposure while taking voriconazole. Advise patients to wear protective clothing and use sunscreen with a high sun protection factor if in sunlight.
- Refer patients with phototoxic reactions to a dermatologist and consider stopping voriconazole treatment.
- If voriconazole is continued despite a phototoxic reaction, check the skin frequently and thoroughly to detect and manage pre-cancerous lesions as early as possible.
- Stop voriconazole if pre-cancerous skin lesions or squamous cell carcinoma are identified. Note that patients may develop squamous cell carcinoma without a prior phototoxic reaction.
Patient alert card (41Kb)
Call for reporting
Please report suspected side effects of any medicine or vaccine to the MHRA through the Yellow Card Scheme online at www.mhra.gov.uk/yellowcard. When reporting please ensure to include the name of the specific product administered.
Article citation: Drug Safety Update volume 7 issue 10, May 2014: A2.
Published: 30 May 2014
Therapeutic area: Infectious disease