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Health written question – answered on 18th June 2009.

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Photo of Jim Dobbin Jim Dobbin Labour, Heywood and Middleton

To ask the Secretary of State for Health what recent research the Medicines and Healthcare products Regulatory Agency has evaluated on the safety of use of benzodiazepine tranquillisers in clinical practice; and whether it plans to (a) update product information for prescribers and patients and (b) take other steps in response to the findings of such research.

Photo of Mike O'Brien Mike O'Brien Minister of State (Health Services), Department of Health

The Medicines and Healthcare products Regulatory Agency (MHRA) continuously monitors the safety of all medicines in routine clinical practice in the United Kingdom, and where necessary, takes suitable action to safeguard public health.

The MHRA uses a variety of methods of collecting information on medicines safety in clinical use. Health care professionals and patients are encouraged to report suspected adverse drug reactions via the Yellow Card Scheme, including the occurrence of dependence and addiction. Pharmaceutical companies are legally obliged to report such cases to the MHRA. These data are carefully and regularly screened to identify possible new drug safety signals.

No new safety signals have been identified recently in relation to benzodiazepines which would require further regulatory action individually or as a class. As new data become available the MHRA keeps the need for regulatory action under review.

The current product information for health care professionals and patients accurately reflects the information known about the risks associated with benzodiazepine use and includes extensive warnings. Patient information leaflets are now being user tested to ensure that the advice is clear and accessible for patients.

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