Novartis and Astellas skin creams to get cancer warning

The US Food and Drug Administration (FDA) has ordered that Novartis’ eczema treatment Elidel should carry cancer warnings.

The product along with Astellas Pharma’s Protopic will carry the strongest type of warning in the US.

The FDA pointed out that no link had been found between the products and an increased cancer risk, but since October last year 78 cases had been reported.

Dr Steven Galson, director of the FDA’s Centre for Drug Evaluation and Research, said: “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.

“Today’s actions are aimed at making sure that health care providers and consumers understand the new warnings and that it is important that these products be used as recommended in the label.”

A Novartis spokesman told Reuters: “While Novartis believes this action is not substantiated by scientific or clinical evidence, Novartis has agreed to make the requested changes and will communicate them to physicians and patients so that they can continue to use Elidel as labelled to effectively manage eczema.”

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