A key committee of the European Medicines Agency (EMA) has recommended that ketoconazole tablets, an antifungal drug, be removed from the market. This is because the drug’s severe risks—including liver injury, adrenal gland dysfunction and numerous medication interactions—outweigh its benefits.
EMA action followed that of French drug regulator, the National Agency for the Safety of Medicines and Health Products which had earlier ordered removal of the product from the French market. Once banned by the EMA, none of the 28 member countries can permit the sale of the drug.
Ketoconazole is approved to treat fungal infections and is often used off-label to treat hormonal problems, such as Cushing’s syndrome (symptoms such as rapid weight gain due to prolonged exposure to high levels of the hormone cortisol).
Liver injury caused by ketoconazole tablets occurs in about 1 of 500 patients with no prior history of liver disease. This damage can occur as early as within a month of using the drug. Liver damage can be severe and may even prompt a liver transplant. In rare cases, it can be fatal too.
Although other antifungal meds in the same class such as itraconazole, voriconazole, fluconzole, clotrimazole, econazole, ravuconazole and posaconazole also can cause liver damage, the risk is considerably higher with ketoconazole.
Ketoconazole tablets can also cause problems with the ad- renal glands, affecting the body’s balance of water and salts and minerals (electrolytes) and can interact with numerous drugs, leading to potentially fatal heart rhythm disturbances. Do not use ketoconazole tablets under any circumstances. If you are currently taking the medicine, see your doctor imme- diately to consider switching to another therapy.
Note: This advice applies to the tablet form only and not to ketoconazole creams, shampoos, foams and gels applied to the skin, which can continue to be used as indicated for fungal skin infections since very little of the drug applied is absorbed into the body.
