I am informed by the departments of health and national defence as follows:
a) A Department of National Defence (DND) specific research study to determine whether there are any objectively measurable neuro-psychological effects associated with mefloquine was approved by the Medical Services Research Board in 1995. The study designe is a double blinded, randomized, placebo controlled trial. The suggested sample size requires 280 persons per active and placebo group.
- Age over 18 years; 2. Expected deployment to an area requiring mefloquine (chloroquine resistant area); and 3. Informed, voluntary consent to participate in the study.
- Prior use of mefloquine, with or without an adverse drug reaction; 2. Pre-existing medical disorders, including: seizure disorder, vertigo, neuro-psychiatric disease or cardiac conduction defect; 3. Pregnancy, or the likelihood of pregnancy during the study period and for three months following the study period; and 4. Any allergy to the study medications.
Due to the unavailability of a suitable number of Canadian forces (CF) participants (CF personnel since 1995 not having been deployed in sufficient numbers to a region where the use of mefloquine is required), no subjects have been recruited and participating centres have not been confirmed.
b) Yes, reviews indicate that the experience of the Australian, British and Dutch forces with mefloquine is similar to the Canadian forces experience. The common experience has demonstrated that mefloquine is a very effective prophylaxis against malaria and has few significant side effects, although minor side effects are common. As a result of the reviews, the Australian, British and Dutch forces continue to use mefloquine where appropriate and monitor personnel for side effects.
c) Health Canada did not undertake any formal investigations in October 1997. In October 1994, there were media reports of claims of involvement of Lariam in several incidents in Somalia. Health Canada took immediate and repeated action by requesting the manufacturer to provide all information and adverse drug reaction reports as required under the safety monitoring study (SMS) on the possible use by DND of SMS supplies of Lariam in Canadian forces deployed to Somalia.
d) In October 1994, when Health Canada became aware that Lariam had been administered to Canadian armed forces deployed to Somalia, the department requested from the sponsor an accounting of all the supplies provided to Canadian armed forces personnel by DND, and a listing of adverse drug reactions observed during the course of the use of the drug under the auspices of the SMS. DND indicated to the manufacturer that it was their belief that Lariam issued in Somalia was purchased separately from the SMS. Health Canada concluded that the manufacturer had conducted the trial as per the agreed upon protocol and had responded to the inquiries in a timely manner.
e) The date of the insert in the Lariam (mefloquine) package is December 12, 1997.
f) The date on the most recent product monograph which also contains an information to the consumer section is December 12, 1997.
g) Health Canada has not undertaken a formal review of the insert in the Lariam (mefloquine) package and the prescribing information used in Autralia. However, prescribing information from various countries (Australia, UK, US as well as the Roche International Standard Prescribing Information) when provided by the manufacturer and when examined has been found to be similar to the Canadian labelling information.
h) Health Canada has not undertaken a formal review of the insert in the Lariam (mefloquine) package and the prescribing information used in the United Kingdom. However, prescribing information from various countries (Australia, UK, US as well as the Roche International Standard Prescribing Information) when provided by the manufacturer and subsequently examined, has been found to be similar to the Canadian labelling information.
i) Health Canada has not undertaken a formal review of the differences in timing and content of the Canadian product monograph as compared with the Australian and British product monograph equivalents. Approval for marketing of a product in Canada and the content of the product monograph is based on the data submitted to Health Canada at the time of filing of the submission by the manufacturer. The filing dates as well as the data in support of the new drug submission may or may not be similar to that submitted to other regulatory organizations.
j) Hoffman LaRoche.