An advisory panel recommended to the US Food and Drug Administration that Fujisawa Healthcare's Protopic (tacrolimus) ointment be approved for the treatment of a common skin problem called atopic dermatitis.
The committee recommended Protopic for long-term therapy for moderate to severe atopic dermatitis that does not respond well to conventional treatment. The drug was not recommended as a first-line therapy because the committee favoured starting patients on treatments, such as steroids, that have been on the market for decades and are known to be safe.
Atopic dermatitis causes dry, itchy, scaly skin on the insides of the elbows, the backs of the knees, and on the face.
Protopic may suppress the immune system around the area that it is applied, which raises the potential for the drug to cause a type of cancer called lymphoma. Although Fujisawa contended that the drug did not increase the risk of lymphoma in their studies, the FDA's Dr. Barbara Hill said that the possibility of the drug inducing lymphoma could not be ruled out at this time.
Protopic was approved in Japan in 1999. Fujisawa's Dr. Bill Fitzsimmons said that the rate and type of adverse events in Japan ``are not inconsistent'' with the data from their clinical trials.
Protopic may also increase skin sensitivity to light and the risk of developing skin cancer. ``It has to be made very clear on labeling that patients should avoid sun exposure and use broad spectrum sunscreen,'' committee member Dr. Henry W. Lim, of Henry Ford Hospital, said.