Question No. 138-Mr. John Cummins [asked on September 24, 1998]:

With reference to the neuro-psychiatric side-effects experienced by those taking the anti-malarial drug mefloquine (Lariam):

(a) Of those Canadians administered mefloquine prior to the date of its licensing for general use by the Health Protection Branch in 1993, how many persons committed suicide or attempted to commit suicide and how many of these incidents were associated with alcohol use;

(b) Of those Canadians administered mefloquine after the date of its licensing for general use by the Health Protection Branch in 1993, how many persons committed suicide or attempted to commit suicide and how many of these incidents were associated with alcohol use;

(c) Of those members of the Canadian forces who were administered mefloquine since 1992, how many have attempted suicide or committed suicide; in what year; in Canada or abroad and if abroad name the country;

(d) Of those members of the Canadian forces who were administered mefloquine since 1992 and attempted suicide or committed suicide, how many of these incidents were associated with alcohol use;

(e) Has the Health Protection Branch reviewed the international experience concerning suicides, suicide attempts, and suicidal ideation associated with mefloquine use, and if so when, and what were the results and recommendations of the review, and what steps have been taken to implement the recommendations;

(f) Has the Health Protection Branch reviewed the scientific literature with regard suicides, suicide attempts and suicidal ideation associated with mefloquine use and if so when, and what were the results and recommendations of the review and what steps have been taken to implement the recommendations;

(g) Has the Health Protection Branch revised the administering instructions for mefloquine to include warnings regarding suicides, attempted suicides, suicidal ideation, or the combination of mefloquine and alcohol and if so when. and what action taken, and if not does it plan to do so and if so when;

(h) Have the Canadian forces taken actions in regard to suicides, suicide attempts or suicidal ideation associated with mefloquine use or the combined ingestion of mefloquine and alcohol and if so what was the action and when was it taken, if not why not and when do the forces plan to do so;

(i) Has the Health Protection Branch taken special steps to warn Canadian physicians of the hazards of combining mefloquine and alcohol, when were they taken. and if no action why not, and when does the Branch plan to act and what do they plan to do;

(j) Have the Canadian forces noted or otherwise received letters, doctors reports or other complaints from military families of miscarriages or infant deaths where either the father or mother were administered mefloquine prior to or at the time of the child's conception?

Mr. Peter Adams (Parliamentary Secretary to Leader of the Government in the House of Commons): I am informed by the departments of health and national defence as follows [February 18, 1999] :

(a) There has been only one case reported in Canada prior to 1993 of a patient with a medical history of alcoholism experiencing two episodes of hallucinations, depression and suicide ideation while taking mefloquine for malaria prophylaxis.

(b) There have been four additional cases reported in Canada after 1993. Two cases of suicide and two cases of suicidal ideation have been reported. Of these, two were potentially associated with alcohol use.

(c) Of the Canadian forces members who were administered mefloquine since 1992, there has been one attempted suicide, Somalia 1993, and one suicide, Rwanda 1994.

(d) One.

(c) Health Canada continues to follow the adverse reaction profile of mefloquine but has not formally undertaken a review of the international experience concerning suicides, suicide attempts and suicidal ideation associated with mefloquine use.

(f) Health Canada has not formally undertaken a review of the scientific literature with regard to suicides, suicide attempts or suicidal ideation associated with mefloquine use.

(g) The product monograph for mefloquine has been revised twice subsequent to the issuance of the notice of compliance. There has been no revision to the product monograph relating specifically to suicide. Depression is a contraindication to use of the drug, product monograph revision of January 1997. The precautions section of the product monograph states that "During prophylactic use, if signs of unexplained anxiety, depression, restlessness or confusion arc noticed, these may be considered prodromal to a more serious event. In these cases the drug must be discontinued". Similar information is repeated in the adverse reactions section of the monograph and in the information to the consumer section of the monograph. With respect to mefloquine and alcohol, given that both mefloquine and alcohol are known to have central nervous system effects, in January 1995 a statement was included in the information to the consumer section of the monograph to read as follows: "It is best to avoid alcoholic drinks during treatment with Lariam".

(h) Immediately following a 1995 report in the Canadian Medical Association Journal of a single case of a psychosis developing in association with excessive alcohol and mefloquine prophylaxis, the Canadian forces issued a warning message advising of this potential adverse reaction. Subsequently all deploying personnel arc to be given a briefing regarding potential adverse effects of mefloquine and a warning against excess consumption of alcohol. In addition, alcohol consumption during Canadian forces deployments is closely regulated by the commanding officer.

(i) The product monograph is the official document used to inform physicians of the properties of drugs and the approved instructions for use. As indicated in response to part(g), the product monograph was updated to reflect current information available to Health Canada about mefloquine.

(j) The Canadian forces- Department of National Defence at the national level has had no reports of cases or complaints regarding miscarriages or infant deaths related to use of mefloquine in Canadian forces members. However, if such an event was reported to Health Canada through a dependant's doctor, we would not necessarily be informed.