Notice type: 3rd Party Publications

Date: 31/05/2006


Product name or type:
Safety Review of Protopic (Tacrolimus) - MIMS

MIMS Publication May 2006

Problem Or Issue:
Protopic (tacrolimus) is a topical macrolide immunosuppressant, which was authorised in Ireland and other EU Member States in 2002, following a European assessment procedure. It is approved for use for the following indications: 

• The treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to, or are intolerant of conventional therapies such as topical corticosteroids. 

• The treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who have failed to respond adequately to conventional therapies such as topical corticosteroids. 

As part of the ongoing review and assessment of the safety profile of Protopic, a signal relating to skin cancer, lymphoma and other malignancies in patients who had used Protopic was identified, which led to initiation of a formal EU Referral procedure to reassess the overall benefit/risk profile of the product. This review, which concluded in late March 2006, considered that the overall benefit/risk profile of Protopic remains favourable, subject to amendment of the product information to include additional warnings as outlined below. However, the review also concluded that on the basis of currently available data, a causal relationship between Protopic and the reported cancers and lymphomas could neither be confirmed nor refuted. Accordingly, the company has been requested to continue to closely monitor the product and carry out further studies to obtain more data on the long-term safety profile of Protopic. In the meantime it is recommended that Protopic should be used with caution in order to reduce the potential risk of skin cancer and lymphoma. The product information for Protopic has been strengthened and updated to reflect the outcome of the review and the IMB would like to take this opportunity to highlight the following recommendations: 

• Protopic should only be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. 

• Protopic is not recommended for use in children less than 2 years of age. 

• Protopic should not be used in patients with congenital or acquired immunodeficiences, or in patients on therapy that may cause immunosupression. 

• Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. 

• Lymphadenopathy present at the initiation of therapy should be investigated and kept under review. 

• The lowest strength of Protopic should be used whenever possible. 

• Protopic should be used once daily whenever possible. 

• Protopic should be applied to the affected skin surfaces only, using a thin layer of ointment. 

• Continuous long-term use of Protopic should be avoided. Treatment should be carried out until the eczema clears, and then treatment should be discontinued. 

• Treatment with Protopic may be re-initiated at the first signs of recurrence of disease symptoms. 

• If the disease does not improve, or even worsens, the diagnosis of atopic dermatitis should be reevaluated and further therapeutic options considered. 

Healthcare professionals are requested to report all suspected serious adverse reactions associated with use of Protopic, including any cases of skin cancer, lymphoma or other malignancies, to the IMB, in the usual way.

Background Information Or Related Documents:

« Back