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Dept of Health

Answer

Paul Flynn: To ask the Secretary of State for Health whether the drugs (a) mirtazapine and (b) bupropion are included in the review of selective serotonin reuptake inhibitors anti-depressants and related drugs; and whether either carries a risk of inducing suicidal behaviour comparable with that of the drugs now under review. [178295] Ms Rosie Winterton: Mirtazapine (Zispin) is included in the review of selective serotonin reuptake inhibitors (SSRIs) and related antidepressants. The risks and benefits of mirtazapine in children and adolescents have been considered by the expert working group on SSRIs and the committee on safety of medicines. Analysis of controlled clinical trials did not find an increased risk of suicidal behaviour or self harm in the mirtazapine treated group compared to those treated with a placebo. A summary of the paediatric clinical trial data for mirtazapine was published on the website of the Medicines and Healthcare Products Regulatory Agency in April 2004. The review of a possible risk of suicidal behaviour in adults treated with mirtazapine is ongoing. Bupropion (Zyban) has not been included in the review by the expert working group as it is licensed in the United Kingdom as an aid to smoking cessation. Bupropion has recently undergone a Europe wide review of its risks and benefits. The product information for prescribers states that, depression, rarely including suicidal ideation, has been reported in patients undergoing a smoking cessation attempt. These symptoms have also been reported during Zyban treatment and generally occurred early during the treatment course. Clinicians should be aware of the possible emergence of significant depressive symptoms in patients undergoing a smoking cessation attempt and should advise patients accordingly.

Secondary information

Type

Written question

Reference

178295; 422 c1336W

Session

2003-04

Subjects

Depressive illnesses Drugs Prescription drugs Safety Research Side effects Suicide Antidepressants Bupropion Mirtazapine

Link

View this Written question on www.publications.parliament.uk