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Health written question – answered on 11th July 2012.

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Photo of Jim Dobbin Jim Dobbin Labour, Heywood and Middleton

To ask the Secretary of State for Health pursuant to the answer of 26 June 2012, Official Report, column 222W, on antidepressants, what scientific and medical advice he considered on the safety for patients of withdrawing from Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants over several weeks; and which specialists in SSRI withdrawal were recommended by the MHRA in its SSRI learning module.

Photo of Simon Burns Simon Burns The Minister of State, Department of Health

Ongoing concerns about the safety of the selective serotonin reuptake inhibitors (SSRIs) in early 2003 prompted a review by an Expert Working Group of the Committee on Safety of Medicines (the predecessor to the Commission on Human Medicines) into suicidal behaviour and withdrawal reactions associated with the SSRIs. This review examined all available evidence including data from clinical trials, published literature, post-marketing studies, reports of patients' experiences and feedback from meetings with patient support groups. The Medicines and Healthcare products Regulatory Agency (MHRA) published key findings and updated advice to healthcare professionals and patients as the review progressed.

The key findings of the Expert Group were widely communicated to healthcare professionals and the public in December 2004, at the same time as publication of National Institute for Health and Clinical Excellence clinical guidelines on the treatment of depression and anxiety. One of the key findings with respect to the risk of withdrawal reactions was that evidence showed that withdrawal reactions are less severe when the dose is tapered gradually over a period of several weeks according to the patient's needs. The evidence base for the key findings is detailed in the group's comprehensive report, “Report of the CSM Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants”. A copy has already been placed in the Library and is also available on the MHRA website at:

Since completion of the review by the Expert Working Group, every effort has been made to issue updated advice as appropriate and communications have been issued to healthcare professionals via the letters to healthcare professionals, the MHRA website and also Drug Safety Update.

This has included the SSRI Learning module available on the MHRA website, which informs health professionals about actions to manage and minimise the most important risks associated with SSRIs. It provides general information on managing SSRI withdrawal, followed by the following advice:

“Severe cases (of withdrawal) may call for specialist advice and possible switch to an SSRI with longer half-life before gradual tapering.”

The target audience for the learning module will know that 'specialist advice' means a psychiatrist or specialist mental health services. The expectation would be that once referred to such services, the patient will be managed appropriately by drawing in the skills of all relevant specialists.

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