JEDDAH, 20 March 2006 — Medical consultants in the Kingdom have downplayed a warning by the US Food and Drug Administration (FDA) about potential cancer risk from the use of two medicines for the treatment of eczema.
The warning came after cases of skin cancer and lymphoma have been reported in patients who have been using the products, Elidel and Protopic.
The warning is significant as 21 percent of Saudi population suffer from eczema, a noncontagious skin disorder of unknown cause, characterized by inflammation, itching and the formation of scales.
According to a report carried by Al-Riyadh Arabic daily, FDA issued the warning after studying 78 cancer cases.
But a Saudi consultant said the FDA warning was not based on scientific studies. “The cancer cases reported had nothing to do with the two medicines,” said Dr. Abdullah Al-Eissa, a consultant for skin diseases. He suspected that the campaign was part of a war among medical companies.
FDA had issued a public health advisory in March 2005 advising health care professionals about the possible cancer risk, and indicated that it would ask the sponsors to update the labeling to address this possible risk.
The new labeling of the two medicines by FDA clearly states that these drugs are recommended for short term and noncontinuous chronic treatment of mild to moderate atopic dermatitis.
“We are taking steps to ensure that healthcare providers and patients are aware of the possible long-term risks of these products so that they will be used appropriately,” said Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research (CDER).
Astellas Pharma, the manufacturer of Protopic, and Novartis, manufacturer of Elidel cream, said the drugs are safe. “The changes to the label are focused on a potential risk, not on a proven or known risk,” said Joyce Rico, a vice president at Astellas.
