The television report, which aired April 26, 2007, includes a number of photographs showing in stark detail the discolorations and what appear to be growths covering much of Henderson's face and body after he used Elidel, a topical cream prescribed by his doctor to treat eczema.
Did Elidel create a monster?
Henderson describes himself as "a monster" in the photographs, which he says show his condition when it was at its worst. View a videotape of the entire report.
Henderson says he used Elidel for a few months, and it did help his eczema. But then he began to notice a problem: "Everywhere that I applied it on my body, that's where the rashes came."
He was ultimately diagnosed with cancer, and underwent months of cancer treatment.Henderson says there was never any warning of such a potentially serious side effect at the time he was prescribed the drug.
The FDA Warning
In January, 2006, the FDA ordered that a "black box" warning (the highest warning level for potential side effects of a drug) be included in the labeling on packaging for both tacrolimus (Protopic) and pimecrolimus (Elidel).
However, both drugs continue to be manufactured and sold for the treatment of eczema. (It is estimated that ten per cent of the world's population suffers from eczema, a chronic condition causing the skin to become dry, itchy and easily irritated. Eczema tends to "run in the family". It's not contagious, but it can be genetically transferred from one generation of a family to the next.)
Protopic was approved in December 2000 and Elidel in December 2001. Following their approval, the FDA received reports of lymphoma and skin cancer in children and adults treated with the drugs, although the connection between the cancers and the drugs had not been clearly established. Based on the advice of the FDA Pediatric Advisory Committee, the FDA ordered the black box warning to be included in the labeling of the two drugs.
Since the FDA mandated the warning for Elidel and Protopic, prescriptions for these two drugs have declined sharply. Some clinicians are now reluctant to prescribe the medications, which were once used widely in treatment of eczema.
Cancer is a scary word...
Others, like Patricia Witman, M.D., chief of pediatric dermatology at Ohio State University/Columbus Children's Hospital, Columbus, Ohio, take the position that there is no proof that these medications caused cancers, although data relating to long-term use is not yet in.
"The sense I have is that dermatologists are still prescribing these agents," Dr. Witman said, in an interview with Nancy A. Melville of Dermatology Times reported in April, 2007. "I am still prescribing them, but I am spending a lot of time counseling patients about these drugs. My prescribing practice hasn't changed, but my counseling practice has changed."
Dr. Melville says she has prescribed the agents as second-line therapy after a first-line therapy attempt with topical corticosteroids has failed or can't be used in a given case. She says:" I feel obligated to let patients know about the potential side effects. Cancer is a scary word to patients, and we don't know everything about these medications yet."