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Pimecrolimus and tacrolimus


Cautious use recommended

Europe. The benefits associated with pimecrolimus (Elidel) and tacrolimus (Protopic/Protopy) use outweigh their risks, but greater caution is advised to reduce potential skin cancer and lymphoma risks, the European Medicines Agency's (EMEA's) Committee for Medicinal Products for Human Use (CHMP) concluded on completion of a safety review. The CHMP began the safety review after reports of skin cancer and lymphoma in patients using the medications, but, on the basis of available data, was unable to establish a causal relationship; the CHMP has asked for more long-term safety profile data. Patients using the products should not stop or alter their treatment without first consulting their physician, advises the CHMP. Product information changes recommended by the CHMP aim to raise patient and prescriber awareness of potential long-term risks associated with the products' use.
(Reports in WHO database:
Pimecrolimus: skin neoplasm malignant - 4, lymphoma - 5;
tacrolimus: skin neoplasm - 27, lymphoma - 27).
Press Release. European Medicines Agency (EMEA),
14 March 2006 ().