§ Tim LoughtonTo ask the Secretary of State for Health (1) what estimate has been made under the yellow card system of the number of people who have suffered side effects from Seroxat in each of the last five years; [162560]
(2) how many people prescribed Seroxat are known to (a) suffer and (b) have suffered from side effects worthy of note. [162561]
223W
§ Ms Rosie WintertonThe Medicines and Healthcare products Regulatory Agency and Committee on Safety of Medicines receive reports of suspected adverse drug reactions (ADRs) submitted by doctors, dentists, pharmacists and coroners via the yellow card scheme, 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 suspected 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 8,958 reports of suspected ADRs have been received through this scheme in association with paroxetine (Seroxat) since 1990, of which 4,826 were serious (i.e. considered serious by the reporter, were fatal, life-threatening, resulted in hospitalisation or disability, or were medically significant).
The following table provides a breakdown of the total number of reports received in association with paroxetine (Seroxat) annually for the past five years.
Number of reports for paroxetine (Seroxat) 1999 481 2000 433 2001 341 2002 359 2003 241 Comprehensive warnings about the possible side effects of Seroxat, including those which may occur upon withdrawal from treatment, are included in the product information for prescribers and the patient information leaflet.