Ketoconazole oral tablets for skin and nail infections linked to patient death

Ketoconazole oral tablets for skin and nail infections linked to patient death

 ADR BULLETEIN-- BY SHINU.C

Ketoconazole is an antifungal medication that fights infections caused by fungus.This medicine should be used only when you cannot use other antifungal medications.FDA is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not, approved uses of the drug.

FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. In the 18 months ending in June 2015, skin and nail fungal infections were the only diagnoses cited for the use of oral ketoconazole in an office based physician surveys database. Since the 2013 labeling change, one patient death has been reported to the FDA due to liver failure associated with oral ketoconazole prescribed to treat a fungal infection of the nails.

Health care professionals should use ketoconazole tablets only to treat serious fungal infections when no other antifungal therapies are available. Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Other treatment options are available over-the-counter and by prescription, but are also associated with risks that should be weighed against their benefits.

Patients should discuss with their health care professionals the risks and benefits of available therapies before using any medicine to treat skin and nail fungal infections. Patients taking ketoconazole tablets should seek medical attention right away if they experience any of these signs and symptoms of liver problems, which include loss of appetite, nausea, vomiting, or abdominal discomfort; yellowing of the skin or the whites of the eyes (jaundice); unusual darkening of the urine or lightening of the stools; or pain and discomfort in the right upper abdomen where the liver is located.Ketoconazole in tablet form is indicated to treat serious infections caused by fungi and should be used only when other effective therapy is not available or tolerated. It works by killing the fungus or preventing it from growing. The topical forms of ketoconazole

that are applied to the skin or nails have not been associated with liver damage, adrenal- problems, or drug interactions. We urge health care professionals and patients to report side effects involving ketoconazole.