§ Ms CorstonTo ask the Secretary of State for Health if he will list, with dates, the changes made between 1990 and 1997 in the product data sheet issued to patients with the drug Lariam, describing use and possible side-effects; and what were the reasons for the changes. [15193]
§ Mr. MaloneThe changes that have been made to the product information for Lariam—mefloquine—between 1990 and 1997 have been placed in the Library. The reasons for the changes are that new evidence has become available to the marketing authorisation holder and to the Medicines Control Agency. The sources of the 617W information include suspected adverse reactions received through spontaneous adverse reaction reporting schemes and clinical studies on efficacy or safety of the product.
Copies of data sheets that have been included in the Association of the British Pharmaceutical Industry data sheet compendium between 1990 and 1996, along with the current data sheet and the patient information leaflets for the same period, have been placed in the Library.