05/20/2016    

PHARMACEUTICAL NEWS

FDA Issues Warning On Use of Ketoconazole for Skin and Nail Infections

 

FDA is warning healthcare 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 approved label changes for oral ketoconazole tablets in 2013 reflecting these serious risks and to remove the indications for treatment of skin and nail fungal infections. However, an FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. 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. Healthcare professionals should use ketoconazole tablets only to treat serious fungal infections when no other antifungal therapies are available.

 

Source: FDA [5/19/16] via Dr. Wenjay Sung