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 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 agency is also issuing a guide updating patients of its concerns.
A black box warning is the most serious type of warning in prescription drug labeling. The warning will be located lower on the labels of the two drugs than is typical, although a statement higher on the labels will refer to the risk.
“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.
the FDA has received reports of 78 cases of cancers, including skin and lymphoma
As of October, the FDA has received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with the two drugs, said Dr. Stanka Kukich, the acting director of the FDA’s dermatologic and dental drug products division.
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., said in a statement that its drug “is safe and effective when used in a manner consistent with its label.”
“It addresses a theoretical risk a potential risk, not a demonstrated link,” Dr. Joyce Rico, vice president for medical sciences research and development at Astellas, said of the warning.
While the two manufacturers dispute whether there is a cancer link, the FDA felt it had to convey notice of the cancer reports to doctors and patients, said Dr. Julie G. Beitz, an acting director of one of the FDA’s drug evaluation offices.
Along with the small number of cancers reported in both children and adults treated with the drugs
Along with the small number of cancers reported in both children and adults treated with the drugs, animal tests have shown an increase in cancer associated with the drugs, the FDA said last year.
No causal link between use of the drugs and cancer has been established, Beitz said.
The long-term safety of the drugs has not been established, according to the FDA. While both companies are studying that issue, the results may not be known for years, the FDA said.
Elidel and Protopic are applied to the skin to control eczema by suppressing the immune system.
The companies estimate that roughly 10 million people combined have used the two drugs.