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FDA institutes labelling change for Elidel and Protopic

The FDA updates labelling for topical eczema drugs, Elidel Cream and Protopic Ointment

The FDA has announced an updated labelling for two topical eczema drugs, Swiss-headquartered Novartis' Elidel Cream (pimecrolimus) and Japan-based Astellas' Protopic Ointment (tacrolimus).

The labelling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labelling) will be distributed to help ensure that patients on these medicines are aware of the risk.

The new labelling also says that the drugs are recommended for use as second-line treatments only, which means that other prescription topical medicines should be prescribed first. The label also says that use of these drugs in children aged less than two is not recommended.

Dr Steven Galson, director of the FDA's Center for Drug Evaluation and Research (CDER), 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."

Elidel initially won Novartis strong sales over its tolerability and strong marketing campaign. The brand has been in steady decline since 2004, when the cancer risk was identified.

The FDA subsequently imposed a black box warning for Elidel and Astellas' rival product Protopic, despite the fact that the concerns were was based on theoretical risk and not on clinical evidence.

According to Novartis, total global sales of Elidel fell 23 per cent from 2004 to 2005, racking up USD 270m. FY06 sales of Elidel dropped further to USD 179m. Astellas has also seen fading sales for Protopic over the same time period.

30th September 2008

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