The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has said that oral medicines containing ketoconazole ( known in the UK by the brand name Nizoral) should no longer be used for the treatment of fungal infections.
The decision was made because some patients taking these medicines may be at an increased risk of liver damage and the risk outweighs the benefits. Alternative anti-fungal treatments are available.
The decision is only on oral products. Shampoos and creams containing ketoconazole are not affected by the decision.
Dr. Sarah Branch, the Medicines and Healthcare products Regulatory Agency’s (MHRA) 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.
“Patients on these medicines should make a non-urgent appointment with their doctor to discuss alternative treatment”
Notes to Editor
- EMA press release
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.