Update on the Safety of Tacrolimus Ointment for Atopic Dermatitis - Carcinogenic and Skin Infection Risks, Applications for Pediatrics, Pregnant and Nursing Mothers

Abstract

The package insert for tacrolimus ointment (Protopic^® 0.1% ointment, 0.03% ointment) has been reviewed and revised based on the collected high-evidence safety data from both Japanese and foreign epidemiological studies. The risk of carcinogenicity has been removed from the warning, and the contraindication for its use in pregnant women has also been removed. Therefore, tacrolimus ointment can now be used for pregnant and lactating women under the physician's careful supervision. Epidemiological data indicate that the long-term use of tacrolimus ointment is unlikely to increase the risk of skin infections, and a 10 year follow-up study has confirmed the safety of its use in pediatric patients. Consequently, it is important to provide adequate treatment options after fully explaining the new safety profile of this drug to patients and ensuring their thorough understanding.