ICN Drug Reportedly Can Cause Melanoma
A drug produced by Costa Mesa-based ICN Pharmaceuticals to treat the skin disease psoriasis can also cause the deadly skin cancer melanoma, according to a study released this week by the New England Journal of Medicine.
However, ICN officials say they do not plan to pull the drug from the market, because the study was based in part on an earlier course of treatment involving a higher dosage of the drug combined with longer exposure to ultraviolet A light. Psoralen, also known as methoxsalen, is sold under the brand name Oxsoralen by ICN.
ICN officials say patients with psoriasis, which is characterized by itchy, scaly red lesions, must weigh the benefits of treatment with the increased risks of skin cancer. “Every product has an inherent risk in it,” said Herb Lightstone, vice president of corporate development for ICN. But for severe psoriasis, “I don’t think there are very many alternatives out there,” he said.
The study, headed by Dr. Robert Stern of Beth Israel Deaconess Medical Center in Boston, found that people who received at least 250 treatments of ultraviolet A light and psoralen were five times more likely to contract malignant melanoma.
About 15 years after the first treatment, tumors began to surface in the study’s participants. A total of 1,380 people who received treatment in the years 1975-1976 were studied.
Melanoma can be deadly if left untreated. Two of the nine melanoma patients died from cancer.
However, one local cancer expert said it is unlikely that dermatologists will stop prescribing the treatment, especially for the more severe cases of psoriasis. “If it [the psoralen and UV treatment] increases the risk fivefold, that’s still not much of a risk,” said Dr. Robert Dillman, director of the Hoag Cancer Center in Newport Beach.
Indeed, Dillman said that psoriasis patients, most of whom routinely see a dermatologist, are more likely to be diagnosed for melanoma early, so they can be treated effectively. The drug accounts for about $15 million in annual sales for the company, less than 2% of its gross sales, according to Lightstone.
Representatives with investment firm Heartland Advisors, which owns a stake in the company, said the findings were of little concern and they should have no impact on the company’s bottom line.
“It’s immaterial as far as we are concerned,” said Ron Saba with Milwaukee-based Heartland. “It’s such a small part of their product line.”
ICN officials say they have not been contacted by the FDA regarding the study’s findings. However, ICN does plan to fund product research conducted by an independent panel set up by the National Psoriasis Foundation.
Psoralen was introduced in 1954, and the dosage was modified in 1992 to reflect a growing concern for skin cancer risks, company officials said. ICN’s stock, which trades on the New York Stock Exchange, was unchanged Thursday at $22.375.
