6th June 06: Email from MHRA to Janne

Janne Larsson

(email address)

Date: 5^th June 2006

Ref: HPO 5533

Subject: Strattera (atomoxetine) – Safety Review

Dear Mr Larsson

Thank you for your e-mail of 16 May 2006 in which you request an urgent safety review of Strattera (atomoxetine).

A European-wide review of the risks and benefits of Strattera (atomoxetine) in the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents over the age of 6 years was recently completed in January 2006. The review, which was led by the UK, included all available data (both unpublished and published) on the efficacy and safety of Strattera and was considered by both the UK’s expert advisory group the Commission on Human Medicines (CHM) and by the European Commission on Human Medicinal Products (CHMP)’s Pharmacovigilance Working Party (PhVWP). All concerned European Member States, including Sweden, were involved in the PhVWP’s discussion of this review.

This urgent European review was prompted by concerns raised in September 2005 about the possibility of an increased risk of suicidal thoughts and behaviour in children treated with Strattera, in addition to the previously identified risk of rare but severe liver reactions in January 2005. Prescribers and patients in the UK were previously informed of these safety concerns at the times that they were first identified (January 2005 and September 2005).

In February 2006, UK doctors and patients were informed of the conclusions of the risk-benefit review and the product information for prescribers and patients was updated accordingly. The conclusions of the European-wide risk-benefit review were as follows:

           •  overall the balance of risks and benefits of Strattera in the treatment of ADHD in children and adolescents remains positive;

           • prescribers should be reminded that Strattera should only be initiated by and under the supervision of a specialist;

          • warnings on the risk of seizures (fits) and QT prolongation (abnormal heart rhythm) should be included in the product information;

            • the current warnings in the product information about the risk of liver disorders and suicidal thoughts and behaviour accurately reflect the available data.