The FDA slapped "black box" labeling on Novartis' Elidel and Fujisawa Healthcare's Protopic eczema treatments, warning of the potential risk of cancer the longer the products are used.
The actions follow recommendations made by the FDA's pediatric advisory committee during a meeting in February that reviewed the findings of cancer in three different animal species in tests involving the drugs. The data showed the risk of cancer increased as the amount of the drug given was increased. The data also included a small number of reports of cancers in children and adults treated with Elidel or Protopic.
The FDA said yesterday that the manufacturers of the products have agreed to conduct research to determine whether there is an actual risk of cancer in humans, and, if so, its extent. The agency has also asked physicians to weigh the risks and benefits when prescribing the drugs and not to prescribe the drugs for long periods of time or to children or those with a compromised immune system.
Novartis and Fujisawa have been required to report on any cancers seen among Elidel and Protopic users. There have been 29 reports of cancer, including about a dozen of skin cancer and lymphoma.
"We believe a recommendation to add a black-box warning is unsubstantiated by clinical evidence and experience in more than five million patients world-wide," Novartis said in a Wall Street Journal report.