FDA Advisory Committee Recommends ‘Black Box’ Warning for Eczema Treatments
An FDA advisory panel on Tuesday concluded that two common treatments for eczema "may increase the risk of some forms of cancer" and should feature "black box" warnings on their labels, the Washington Post reports.
At least 30 people using Elidel, made by Novartis, or Protopic, made by Fujisawa Healthcare, have developed skin cancer, lymphoma or other cancers. 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, the Post reports.
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 is typically 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 said the agency should "aggressively caution consumers and monitor the drugs' safety," according to the Post. FDA usually follows its panels' recommendations but is not required to do so.
FDA's Dianne Murphy told the panel, "What we are dealing with is an unknown degree of risk," adding, "It will take too many years before we will have a definitive answer. Many children will have been exposed, and we are concerned it will be too little information too late."
Novartis and Fujisawa officials said their products were thoroughly tested in thousands of patients. Thomas Hultsch of Novartis said, "There is no evidence of an increased risk of malignancies." Joy Rico of Fujisawa said, "We are committed to the safety of our patients."
Some patient advocates and dermatologists said the drugs are necessary for people with eczema, specifically those with severe cases. Jim Hendricks of the National Eczema Association said, "These medications have given patients ... some relief for a tortured existence that most people just can't imagine" (Stein, Washington Post, 2/16).