§ Stephen HesfordTo ask the Secretary of State for Health (1) what assessment he has made of the delayed side effects caused by Prozac; [4266]
(2) what research he has undertaken into the delayed side effects caused by Prozac. [4242]
§ Ms BlearsAs with all medicines, the safety of Prozac (fluoxetine) is continually monitored by the Medicines Control Agency (MCA) and the independent expert advisory body, the Committee on Safety of Medicines (CSM).
Part of this monitoring is via the Yellow Card scheme, where health professionals report suspected adverse drug reactions (ADRs) to the MCA/CSM. Doctors are reminded in the British National Formulary about the possibility of delayed adverse effects of medicines and that any suspicion of such an effect should be reported. All reports received are routinely assessed by the MCA. The other data sources regularly used in the monitoring of drug safety in the United Kingdom include formal safety studies, published medical literature, information from pharmaceutical companies and other regulatory authorities throughout the world together with information on the level of drug prescribing.
In 1998, the CSM conducted a detailed review of the safety profile of Prozac and other similar drugs with particular reference to concerns about dependence. The CSM advised that there was insufficient evidence to support such an association. This was published in "Current Problems in Pharmacovigilance" in September 2000.