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Antifungal drugs: Voriconazole linked to risk of phototoxicity, squamous cell carcinoma and liver toxicity


Voriconazole ( Vfend ) is known to be associated with a risk of liver toxicity, phototoxicity, and squamous cell carcinoma of the skin.
Liver function before starting treatment with Voriconazole should be to test and at least weekly during the first month of treatment.
The patients should avoid sunlight exposure while taking Voriconazole.

Voriconazole 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.

MHRA ( Medicines and Healthcare Products Regulatory Agency ) has 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 ).

Advice for healthcare professionals

Liver toxicity - 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. ( Xagena )

Source: MHRA - Drug Safety Update volume 7 issue 10, 2014: A2

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