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Fungal infection drug banned due to liver risk

The European Medicines Agency has banned oral medicines containing ketoconazole – sold under the brand name Nizoral – for treating fungal infections.

A review by the agency found the risks of developing liver damage outweighed the benefits of the drug.

The decision refers only to oral products. Shampoos and creams containing ketoconazole are not affected by the decision.

The UK’s Medicines and Healthcare products Regulatory Agency said: “These medicines are not widely used in the UK but this is still important advice.”

Dr Sarah Branch, the Medicines and Healthcare products Regulatory Agency’s deputy director of vigilance and risk management of medicines division, said: “These medicines are not widely used in the UK but this is still important advice.

“Whilst these products already contain warnings about the risk of liver damage, the review by the European Medicines Agency has found that the risks outweigh the benefits and should no longer be used for the treatment of fungal infections.”

Although the potential for hepatotoxicity is a class effect with azole antifungals, the data assessed show that the incidence and seriousness of hepatotoxicity is higher with ketoconazole than with other antifungal agents, the EMA said.

Reported cases of hepatotoxicity included hepatitis, cirrhosis and liver failure with fatal outcomes or requiring liver transplantation.

The onset of hepatotoxicity occurred generally between one and six months after starting treatment, but has also been reported earlier than one month after starting treatment, and at the recommended daily dose of 200mg, the agency added.

 

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