§ Mr. FlynnTo ask the Secretary of State for Health how many reports of suspected adverse reactions associated with Lariam (Mefloquine) were reported to the Medicines Control Agency, relative to the number of prescriptions written, in each year from 1989 to 1998; and if he will make a statement. [48699]
§ Ms JowellThe number of suspected adverse reactions reported to the Committee on Safety of Medicines and the Medicines Control Agency from 1 July 1989 to 2 July 1998 for mefloquine (brand name, Lariam) as the suspect drug in the United Kingdom, and the number of prescription items dispensed in the community for mefloquine, from 1989 to 1997 in England are given in the table:
Year Total number of suspected adverse reactions Number of reports Number of prescriptions dispensed in the community in England (000) 1989 0 0 — 1990 54 19 2.8 1991 58 27 7.0 1992 51 22 10.6 1993 182 72 40.3 1994 606 234 160.7 1995 1,251 458 56.6 1996 1,376 469 18.6 1997 641 2,229 16.9 Up to 2 July 1998 179 65 — A report of a suspected adverse drug reaction (ADR) does not necessarily mean that it was caused by the drug. Each report relates to one patient. Patients may have more than one suspected reaction and the number of reactions given therefore exceeds the number of patients affected as seen in the table. The number of reports received for a medicine is influenced by a number of factors including the extent of its usage and publicity related to the medicine as well as its intrinsic toxicity.
Mefloquine was first dispensed in 1990. The prescription information was obtained from the prescription cost analysis system. Prescription cost analysis is based on information obtained from the Prescription Pricing Authority. The prescription data for 1990 are not consistent with data from 1991 to 1997. The figure for 1990 is based on prescription fees and on a sample of 1 in 200 prescriptions dispensed by community pharmacists only. Figures for 1991 onwards are based on items and cover all prescriptions dispensed by community pharmacists, dispensing doctors and prescriptions submitted by prescribing doctors for items personally administered.
563WThe prescription data provided include prescriptions dispensed in England only, whereas the spontaneous ADR data include reactions occurring throughout the UK. Therefore, these data sets are not directly comparable.