
Having assessed the available data on the risks with oral ketoconazole, the CHMP concluded that, although liver injury such as hepatitis is a known side effect of antifungal medicines, the incidence and the seriousness of liver injury with oral ketoconazole were higher than with other antifungals. European legislation requires that there is a coordinated European approach when a Member State takes regulatory action in relation to a medicine that is authorised in more than one country. The French medicine agency, the National Agency for the Safety of Medicine and Health Products (ANSM), concluded that the benefit-risk balance of oral ketoconazole was negative because of a high level of liver injury associated with the medicine and in view of the currently available alternative treatments, which are deemed to be safer. The EU-wide review of oral ketoconazole was triggered by the suspension of the medicine in France. Doctors should no longer prescribe oral ketoconazole and should review patients' treatment options. Patients currently taking oral ketoconazole for fungal infections should make a non-urgent appointment with their doctor to discuss suitable alternative treatments. The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections. 25 July 2013, the European Medicines Agency's Committee on Medicinal Products for Human Use ( CHMP) recommended that the marketing authorisations of oral ketoconazole-containing medicines should be suspended throughout the European Union (EU). fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-limits-usage-nizoral-ketoconazole-oral-tablets-due-potentially

Some studies suggest that ketoconazole might be effective at treating fungal acne. Topical antifungal creams can also help control the growth of Malassezia. A dermatologist may prescribe an oral antifungal medication such as fluconazole or itraconazole to help treat fungal acne. However, because Nizoral (ketoconazole) primarily targets the growth of fungal infections, it can be an effective treatment for fungal acne.Īntifungal medications are the primary treatment for fungal acne. Unlike typical acne, which is caused by oil and bacteria buildup, fungal acne doesn’t respond to traditional acne treatments.
Ketoconazole xteam 60 skin#
This yeast is present on the skin of 75 to 98 percent of healthy individuals. This condition typically causes clusters of small, itchy bumps on oily parts of the skin, such as the back, chest, shoulders, or face.įungal acne is caused by an overgrowth of Malassezia yeast on the skin. Fungi can cause a type of acne that’s medically known as pityrosporum folliculitis.
