The labels on two prescription creams to treat eczema will have to bear “black box” warnings of possible cancer risks.
The Food and Drug Administration action on Thursday follows an agency advisory committee recommendation last February that Elidel cream and Protopic ointment carry the label warnings. The new labeling also will clarify that the two drugs are recommended for use only after other prescription topical medicines have been tried by patients, the FDA said.
The “black-box” warning will be located lower down on the labels of the drugs than is typical.
“This is something that is a possible risk — is a long-term possibility and is something that still needs to be researched,” FDA spokeswoman Susan Cruzan said.
Novartis Pharmaceuticals, which makes Elidel, said in a statement Thursday that it remained confident in the safety and efficacy of Elidel.
“While Novartis believes this action is not substantiated by scientific or clinical evidence, Novartis has agreed to make the requested changes,” the company said.
Astellas Pharma Inc., formed through the merger of Protopic maker Fujisawa Healthcare Inc. and Yamanouchi Pharmaceutical Co., did not immediately return an e-mail seeking comment.
Animal tests have shown an increase in cancer associated with the drugs, and a small number of cancers have been reported in children and adults treated with the drugs, FDA said last year. No causal link between use of the drugs and cancer has been established, the FDA said.
Elidel and Protopic are applied to the skin to control eczema by suppressing the immune system.
