"The safety of using Elidel cream for a long period of time is not known," concedes www.elidel.com, a website sponsored by Novartis.
More is known about the short-term effects of Elidel. Unfortunately, the news isn't good: "a very small number of people who have used Elidel cream have had skin cancer or lymphoma," states www.elidel.com.
The U.S. Food and Drug Administration (FDA) approved Elidel for use in December 2001. The product came as welcome relief for eczema—a nasty skin rash that turns flesh dry, itchy and red and affects a large number of people.
"Eczema or atopic dermatitis is one of the most common skin disorders seen in infants and children, affecting 10 to 15 per cent of the childhood population," states the FDA.
A few years after approving the drug, the FDA decided there was a cancer-risk associated with Elidel. In a public health advisory published in March, 2005 (an advisory that was also aimed at Protopic, another anti-eczema product made by Japanese company Astellas), the FDA recommended that Elidel only be used as a "second-line agent for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of, other treatments."
Adults or children with weakened immune systems were advised to avoid the drug. The FDA also urged parents not to use Elidel on kids younger than two years old.
"The effect of Elidel on the developing immune system in infants and children is not known," explained the agency's public health advisory. "In clinical studies, infants and children younger than two years old treated with Elidel had a higher rate of upper respiratory infections than did those treated with placebo cream."
In addition to possibly hurting people's immune systems, the FDA admitted that Elidel might also be carcinogenic.
"Animal studies have shown that three different species of animals developed cancer following exposure to [Elidel and Protopic] applied topically, or given by mouth, including mice, rats and a recent study of monkeys," the FDA explained.
"As of December 2004, the FDA had received 10 cases of postmarketing reports linking Elidel with cancer-related adverse events," added the public health advisory. "Four cases occurred in children, three of these in children less than six years old. The other six cases occurred in adults."
In an April 2005 press release, Health Canada (the Canadian equivalent of the FDA) chimed in with its own statistics. "In Canada, there have been two reports of cancer-related adverse events for Elidel," reported the agency.
With all this in mind, the FDA approved tougher warning labels for Elidel (and Protopic) in January 2006. The warning consisted of a black box on the product's packaging that alerted consumers that the drug carried a potential cancer risk.
Problem is, this warning came after Elidel had already been on the market for nearly five years. No wonder lawsuits have started flying against Novartis, for taking years to inform the public that their eczema fighting cream might also cause cancer and respiratory illness.