FDA Says Two Eczema Treatments Will Carry Black Box Warnings
FDA on Thursday said that two eczema treatments will be required to carry "black box" warning labels alerting physicians that they have been linked to an increased cancer risk and urging caution when prescribing them, the Washington Post reports (Washington Post, 3/11). An FDA advisory panel on Feb. 15 concluded that Elidel, made by Novartis, and Protopic, made by Fujisawa Healthcare, could increase the risk for some forms of cancer and should feature black box warnings.
More than 12 million prescriptions have been filled since Elidel and Protopic were introduced in 2000 and 2001, respectively. The drugs are approved for short-term or intermittent use in adults and children ages two or older, but panelists were concerned that the treatments are believed to be widely prescribed to children younger than age two. In addition, Jeffrey Cohen of NIH's National Institute of Allergy and Infectious Diseases said the drugs' suppression of the immune system -- the method by which they manage eczema -- could impede the body's ability to control Epstein-Barr, a common virus that typically is harmless but can cause cancer in some instances. FDA officials told the panel that it could take years for researchers to find definitive answers.
The panel recommended that the agency strongly caution consumers and monitor the drugs' safety (California Healthline, 2/16).
FDA recommended that physicians prescribe Elidel and Protopic only for short-term and intermittent use in patients who do not respond to or cannot tolerate other treatments; prescribe the minimum amount needed to control symptoms; and refrain from prescribing the drugs to children and adults who have weakened or compromised immune systems. In addition, the agency is developing a medication guide for patients.
Officials said that the manufacturers have agreed to test the drugs further (AP/Long Island Newsday, 3/10). A spokesperson for Novartis said, "We believe a recommendation to add a black box warning is unsubstantiated by clinical evidence and experience in more than five million patients worldwide" (Corbett Dooren, Wall Street Journal, 3/11).