Volume 13 - Issue 4 - April 2005

T he main reasons cited by the FDA for issuing a public health advisory on topical calcineurin inhibitors (TCIs), which the agency did on March 10, include that there is a potential risk of cancer. According to what the agency wrote in the advisory, this concern is “based on information from animal studies, case reports in a small number of patients, and how these drugs work.” To date, more than 12 million prescriptions of pimecrolimus (Elidel) and tacrolimus (Protopic) have been written; 14% and 7%, respectively, have been for children under age 2, according to the FDA. Thirty cases of tu