Last week it was announced that Traci Reilly is filing suit on the manufacturers of Protopic and Elidel, the topical eczema drugs she

believes caused her to develop breast cancer. Reilly will join the many others who are reported to have filed wrongful death and injury suits related to the use of these drugs. Despite the black box warnings ordered by the FDA last year, along with requests for long-term cancer studies, the drug companies maintain that, used as directed, the drugs are safe and there is no conclusive evidence linking the drugs to cancer. Conclusive or not, there is certainly enough anecdotal evidence to justify switching to a skin care treatment product that is effective as eczema treatment, but is not potentially life threatening.

What are the facts about these drugs?

The active ingredients in Protopic (tacrolimus) and Elidel (pimecrolimus) are known to suppress the immune system. Tacrolimus, in a form of Protopic known as Prograf, had previously been approved in oral and injectible forms for prevention of organ rejection in patients getting liver or kidney transplants. According to the FDA, Prograf is "known to cause both skin cancers and lymphoma in humans by suppressing the body's normal immune defenses against cancer."

An FDA memo revealed that the long-term safety profile on humans was unknown prior to approval, although animals tested with the products had developed cancer.

The FDA approval specified that the drugs were only to be used where all other treatment options had failed, and only in adults and children over two years of age. Despite these warnings, the drugs were heavily promoted for use in children and 25 percent of the prescriptions issued for the drugs from June 2003 to May 2004 were for children under two.

As of January 2006, when the black box warning was ordered, at least 14 cases of cancer were reported to the FDA's division of pediatric drug development. Half of the reports involved cancer of the immune system, as well as many infections. One report detailed the death of an eight month old child who had a heart attack caused by severe infection after prolonged application of Protopic.

As statistics show that doctors report only 5% of drug side effects to the FDA, it is reasonable to assume that the problem affected significantly more than 14 patients.

Now the effects are being seen on adults, and the lawsuits are piling up. Traci Reilly used the drugs for one year. She stopped when she was diagnosed with breast cancer. Although not aware of the possible relationship between the two at that time, she notes that the cancer developed in the exact spot where she applied the drugs. Two years after her diagnosis, during which time she had chemotherapy and a mastectomy, she received the letter containing the warning of the dangers of the drugs.

The head of pediatric dermatology at a major hospital, commenting on the situation, stated that every drug has potential risks and benefits and that both have to be weighed when considering the possibility of using these drugs. While organ transplants can often be life and death situations, and the drugs may therefore be justified, eczema, while uncomfortable and sometimes unsightly, is not a life-threatening situation. Does it warrant a skin care treatment product that contains a life-threatening drug?

The most successful eczema treatment, as with many physical problems, is to remove the cause. Eighty percent of eczema is caused by contact with harsh, irritating chemicals. Are we talking about workers with their hands dipped in caustic substances all day? No, we're talking about the modern American household: the chemicals in and on our food, in our cosmetics, soaps, shampoos, household cleansers, and our skin care drugs and other products. Elimination of these chemicals and using a skin care treatment product that will protect you from the rest isn't just good eczema treatment, it's an integral part of the healthy lifestyle needed to avoid skin diseases, and many other health problems. The choice is yours.