Cancer Warnings to Be Added to 2 Ointments
WASHINGTON — The labels on two prescription creams to treat eczema will have to bear warnings of possible cancer risks, the Food and Drug Administration said Thursday.
The FDA action follows an agency advisory committee recommendation in February that Elidel and Protopic 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 on 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.
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.â€
“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.
Though the two manufacturers dispute whether there is a cancer link, the FDA believed 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 cancers reported in children and adults treated with the medications, animal tests have shown an increase in cancer associated with the drugs, the FDA said.
