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Health: Drugs

Volume 713: debated on Tuesday 20 October 2009

Questions

Asked by

To ask Her Majesty's Government what recent advice has been published by the Chief Medical Officer and the National Institute of Health and Clinical Excellence on the side-effects of prescribed drugs. [HL5568]

The National Institute for Health and Clinical Excellence (NICE) routinely considers the side-effects of specific treatments when developing its recommendations on clinical and cost effectiveness and such information is contained in NICE's published guidance available on its website at www.nice.org.uk.

The Chief Medical Officer has not recently issued any such advice.

The safety of all medicines is kept under continuous review by the Medicines and Healthcare Products Regulatory Agency in conjunction with its independent scientific advisory body, the Commission on Human Medicines.

Asked by

To ask Her Majesty's Government what steps they will take to increase patients' awareness of the potential withdrawal symptoms of selective serotonin reuptake inhibitors. [HL5569]

The issue of withdrawal reactions following use of selective serotonin reuptake inhibitors (SSRIs) has been under close review by the Medicines and Healthcare Products Regulatory Agency (MHRA) and its predecessor, the Medicines Control Agency, since the early 1990s. Any new data have been carefully evaluated as they become available and updated advice issued as appropriate.

Warnings about the risk of withdrawal reactions upon stopping treatment with SSRIs have been included in the patient information leaflets (PILs) for SSRIs for many years. Following a comprehensive review by an expert working group on the safety of SSRIs, established by the Committee on Safety of Medicines, the warnings in the product information for prescribers and the PILs were updated to include clear and detailed advice on the management of withdrawal. A thorough evaluation of all available data coupled with feedback from patients and patient organisations informed the updates.

Current National Institute for Health and Clinical Excellence guidance recommends clearly that all patients prescribed antidepressants should be informed about the risk of withdrawal reactions and the importance of gradual withdrawal over several weeks. The British National Formulary (BNF), which is distributed by the Department of Health to doctors and community pharmacies, also contains information on withdrawal reactions following stopping treatment with SSRIs. The MHRA is in discussion with the BNF over whether there is scope for further updates to this information to aid discussions between prescribers and patients.