§ Ms CorstonTo ask the Secretary of State for Health how many cases of reported and suspected adverse reactions to Lariam have been notified during the last three years for which figures are available. [32282]
§ Mr. MaloneThe Medicines Control Agency has received 878 reports of 2,493 suspected adverse reactions associated with Lariam between 7 June 1993 and 7 June 1996. During this time, in excess of four hundred thousand patients have received Lariam. The reports received are consistent with the known safety profile of Lariam as described in the authorised product information.
§ Ms CorstonTo ask the Secretary of State for Health what representations he has received from professional bodies and the Committee on Safety of Medicines on the anti-malarial drug Lariam. [32284]
§ Mr. MaloneThe Department and the Medicines Control Agency have received representations from doctors and other health professionals and bodies representing health professionals and have responded to the issues raised. The Committee on Safety of Medicines, as an independent expert advisory body to the Licensing Authority, provides advice on the quality, efficacy and safety of medicines, including Lariam, to the Licensing Authority.
§ Ms CorstonTo ask the Secretary of State for Health if he will make a statement on the indicated side effects of the drug Lariam. [32283]
§ Mr. MaloneWarnings on the side effects of Lariam are included in the product information. This includes the data sheet provided to all doctors and pharmacists and the information leaflet for patients.