§ Mr. Paul MarsdenTo ask the Secretary of State for Health how many children have(a) self-harmed and (b) committed suicide whilst taking prescribed paroxetine in each year since 1997. [122390]
§ Ms Rosie WintertonThe Medicines Control Agency (MCA) and Committee on Safety of Medicines (CSM) receive reports of suspected adverse drug reactions (ADRs) submitted by doctors, dentists, pharmacists and coroners via the Yellow Card Scheme by doctors and there is a legal requirement for companies to report suspected ADRs to their drugs.
The number of reports received via the Yellow Card Scheme does not directly equate to the number of people who suffer adverse reactions to drugs for a number of reasons including an unknown level of under reporting. It is important to note that the reporting of a reaction does not necessarily mean it was caused by the drug and may relate to other factors such as the patient's underlying illness or other medicines taken concurrently.
A total of 196 reports of 'suspected' ADRs have been received through this scheme in association with paroxetine in children aged 18 years or under, including three reports of deliberate self-harm, all occurring in 1999 and two reports of suicide (accomplished)—one each occurring in 2002 and 2003.