Following a review of the safety of these products the EMEA concluded that the benefits outweigh the risks but that greater caution should be used when prescribing in order to reduce potential risks of skin cancer and lymphoma.
Changes in the product information have been recommended to warn patients and prescribers about the potential risks of these treatments. Additionally, prescribers are reminded that these products:
- should only be initiated by clinicians with experience of diagnosis and treatment of atopic dermatitis
- should not be used in children under 2 years old
- should only be used when a topical corticosteroid should not or cannot be used
- should be applied sparingly, at the lowest effective dose for the shortest possible duration
- should not be used long term or continuously
Further information is contained in the question and answer document on the EMEA website.
Action: Clinicians should be aware of these recommendations and ensure they are implemented.
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