A prescription cream and an ointment that millions of Americans use to control eczema should carry strong warnings to alert consumers that the drugs may increase the risk of some forms of cancer, especially among children, a federal panel concluded yesterday.
Although the risks posed by Elidel and Protopic remain far from clear, the Food and Drug Administration advisory panel said the agency should take steps to aggressively caution consumers and monitor the drugs' safety, including adding a prominent "black box" to the labels.
The FDA is not required to follow the advice of its expert panels but usually does.
Officials at Novartis Pharmaceuticals Corp., which makes Elidel, said they were disappointed by the recommendation, which they said was unnecessary.
Protopic was approved in 2000 and Elidel in 2001 to treat eczema, a chronic, incurable skin condition that causes sometimes disfiguring and even disabling redness, itching and scaling for millions of Americans. Both products control the condition by suppressing the immune system.
Before their approval, the only available treatment was steroid drugs, which can cause harmful side effects.
Although the new medications were approved only for short-term or intermittent use by adults and children 2 or older, the treatments have become increasingly popular, and the number of new prescriptions has risen especially quickly in the past year. More than 12 million prescriptions have been written, with Elidel much more widely advertised than Protopic and far outselling it.
The number of prescriptions sold for pediatric use has increased the quickest, and both medications are believed to be widely used for babies younger than 2.
When the medications were approved, experts said animal and laboratory studies suggested that the drugs might increase the risk of cancer. That prompted the FDA to require the companies to monitor closely their safety record.
Agency officials have since become increasingly concerned as the drugs' popularity soared and the number of cancers reported among users slowly accumulated. At least 30 cases have been reported -- primarily forms of skin cancer and lymphoma, an immune-system cancer.
"There is an emerging signal in the types of tumors being reported," said the FDA's Bindi Nikhar.
During a day-long hearing, FDA officials described evidence from animal studies suggesting a cancer risk, including a monkey study that indicated a possible link to lymphoma.
Jeffrey Cohen of the National Institute of Allergy and Infectious Diseases told the panel that the drugs could increase the risk of cancer by suppressing the immune system's ability to control the Epstein-Barr virus, a ubiquitous infection that is often harmless but can lead to cancer.
FDA officials said it would take years before research could clarify the situation.
"What we are dealing with is an unknown degree of risk," the FDA's Dianne Murphy told the panel. "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."
Officials from Novartis and Fujisawa Healthcare Inc., which makes Protopic, argued that both products were extensively tested in thousands of patients and that there was no sign of cancer occurring more frequently among those using the products.
"There is no evidence of an increased risk of malignancies," said Thomas Hultsch of Novartis.
Both companies said they are carefully monitoring users for signs of serious side effects.
"We are committed to the safety of our patients," said M. Joy Rico of Fujisawa.
Several dermatologists and patients' representatives told the panel that the drugs are crucial for people suffering from the condition, especially those with severe cases.
"These medications have given patients . . . some relief for a tortured existence that most people just can't imagine," said Jim Hendricks of the National Eczema Association for Science and Education, an advocacy group for patients.