US Food and Drug Administration advisors have recommended that tighter warnings be added to the labels of two topical immunosuppressants, based on an analysis of post-marketing adverse event reports.

Novartis’ Elidel (pimecrolimus) and Fujisawa’s Protopic (tacrolimus), both approved for the second-line treatment of eczema, should carry a black box warning to highlight the risks of malignancies such as skin cancer and lymphoma, and to state clearly that these drugs must not be used in children aged under two.

At a February 15 meeting, members of the FDA’s advisory panel said that there was no definitive link between the creams and the cancers, but that the post-marketing AER data suggested that further monitoring was warranted.

Since its launch in the US at the end of 2001, Elidel has been linked to 54 serious adverse events in children aged under two, and eight cancers in all age groups, according to the FDA’s Office of Drug Safety. Meanwhile, Protopic has been associated with 10 serious AERs and 17 malignancies between its launch in 2000 and September 2004.

Both companies said they did not believe there was solid link between their drugs and the malignancies, but would be conducting additional safety reviews and studies to investigate the possibility. The FDA is not required to follow its panels’ advice, but often does so.

Last year, Elidel achieved sales of $349 million dollars for Novartis [[21/01/05a]], while Protopic brought in 16.4 billion yen ($156 million) for Fujisawa in the nine months ended December 31, 2004.