Government scientists, concerned that two prescription creams used widely for a common skin condition may increase the risk of certain cancers, especially among children, will propose adding strong new warnings to the product labels.
A handful of cases of cancer have been reported among adults and children using the creams, sold under brand names Elidel and Protopic, and animal and laboratory studies suggest the drugs could be to blame, according to a new Food and Drug Administration analysis.
"The evidence raises serious safety concerns in children regarding the potential for carcinogenicity in humans treated with these agents," wrote Jean Temeck of the FDA's division of pediatric drug development in a recommendation posted late yesterday on the agency's Web site.
The document was one of several posted in preparation for a meeting of an expert panel next week to assess the safety of the creams and recommend what action the agency should take.
Protopic and Elidel were approved in 2000 and 2001, respectively, to treat eczema, a common, chronic skin condition that causes redness and itching. Before the new creams, the only treatment had been steroid creams and ointments, which can be used only for short periods and can have a variety of side effects.
The new creams, which were seen as effective and much safer, immediately became popular. At least 5 million prescriptions have been written for the creams.
The creams were approved for short-term or intermittent use by adults and children age 2 and older, but Novartis Pharmaceuticals Corp. has marketed Elidel aggressively, and both creams are believed to be widely used for longer periods and among babies.
"These products are being widely used to treat . . . a non-life-threatening disease, and heavily advertised for use in young children without appreciation . . . regarding the potential for carcinogenic risk," Temeck wrote.
Both Novartis and Fujisawa Healthcare Inc., which makes Protopic, defended the safety of their products to the FDA.
"Elidel is an effective, steroid-free treatment for mild to moderate eczema and has a well-established safety profile," Novartis spokesman Tom Jones added in an e-mail.
Because the drugs work by suppressing the immune system, scientists had been concerned that they could increase the risk of cancer. As a result, when the FDA approved the creams the agency required both companies to monitor whether any cancers were reported among users.
In 2003, the agency convened an expert panel to examine the evidence to date, but at that time only seven possible cases had been reported, so the agency decided to continue to monitor the situation.
Since then, however, a study involving monkeys has suggested the creams might cause lymphoma, a cancer of the immune system, and reports of a variety of cancers in humans using the creams have continued to rise.
At least seven cases of lymphoma have been reported, as well as at least seven cases of skin cancer and a handful of others, Temeck wrote. Several children reported infections, including an 8-month-old boy whose infection was so severe he suffered a heart attack after Protopic was applied "over his entire body for six months," she wrote.
While it remains far from proven that the creams are causing the complications, "there is a need for a stronger approach to the communication and minimization of the potential risk of cancer," Dianne Murphy, director of the FDA's office of pediatric therapeutics, wrote in another document.
"We believe regulatory action is needed at this time since a definitive answer to the carcinogenic risk of these products will not be known for years," Temeck wrote.
The addition of a possible "black box" warning to the label is one of several recommendations that the committee will consider, an agency spokesman said.
The concern comes as the FDA has come under intense criticism for failing to protect the public from potentially dangerous drugs. The blockbuster painkiller Vioxx was recently pulled from the market because of concerns that it and similar agents may increase the risk of heart attacks and strokes.
The advisory committee will focus on children because exposure to a potential cancer-causing agent poses a greater risk to the young, but its recommendations would apply to adults as well, the spokesman said.
Although the FDA is not bound to follow the recommendations of its advisory panels, it usually does.