- Prescribing Advice for GPs - https://www.prescriber.org.uk -

FDA issue Eczema drug warning

The American Food and Drugs Administration (FDA) has approved an updated label containing a boxed warning about cancer risks for pimecrolimus (Elidel)® and tacrolimus (Protopic)®.

The FDA is taking this action to "ensure that healthcare providers and patients are aware of the possible long-term risks of these products". This follows rare reports of cancer in patients using these products, although at this time no causal relationship has been established.

Action: The safety of these products is still under review and as detailed here, clinicians should ensure these products are used as per the NICE Technology Appraisal and within the product licence. (Note: neither product is licensed for used in patients under 2 years old).

Summary of Product Characteristics for Tacrolimus
Summary of Product Characteristics for Pimecrolimus