The Pharmaceutical Journal
Vol 276 No 7394 p374
1 April 2006

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News summary

EMEA advises caution in use of Protopic and Elidel

Benefits associated with the use of Protopic (tacrolimus) and Elidel (pimecrolimus) for the topical treatment of atopic eczema outweigh the risks, the European Medicines Agency (EMEA) has concluded, following a safety review. However, the EMEA says that these products should be used with greater caution to reduce potential long-term risks of skin cancer and lymphoma.

The safety review was conducted following reports that skin cancer and lymphoma developed in patients who had used these products. The EMEA’s Committee for Medicinal Products for Human Use says that there was insufficient evidence to conclude whether the products caused the reported cases and has asked the manufacturers to gather more data on their long-term safety profiles to ensure that they remain acceptable.

The committee has recommended changes to the product literature to raise awareness of the potential risks among both patients and prescribers. Warnings that these products should be used intermittently, should not be applied to cancerous or pre-cancerous lesions and should not be used in immunocompromised individuals have been strengthened.

The EMEA advises that patients should not stop using the products without consulting their prescriber.

A question and answer document detailing the new prescribing information is available from the EMEA website (PDF 60K)