Veterans Affairs committee  As per my two colleagues, I'd like to thank the committee for the opportunity to appear before it to try to provide clarity on the role of Health Canada in the oversight of products, and, as their safety profile evolves, on the steps we take to ensure that the labelling adequatel

Veterans Affairs committee  I can't answer that question; I don't know.

Veterans Affairs committee  I can't speak to what happened at the clinical trial site that DND was supervising. The information I have is that Health Canada approved the trial. The trial was submitted by the manufacturer, Hoffmann-La Roche, and as part of that trial there was a protocol, there was an inform

Veterans Affairs committee  What I could tell you is that as a follow-up to the recommendations coming from the OAG audit, there was a recommendation to Health Canada to put in place better oversight of clinical trials. The federal government introduced Division 5, which is clinical trial regulations, in 20

Veterans Affairs committee  We get ADR reports around neuropsychiatric behaviours that have occurred with individuals when they're taking mefloquine. These have been reported not just to Health Canada but to other jurisdictions. I can't speak to whether violence is one or not—I don't have that information i

Veterans Affairs committee  Thank you for the question. It's important to point out that with any medication, after it is market-authorized, there is increasing exposure to the drug as more and more patients use it. In clinical trials that were done to prove the therapy, there may have been slight signals

Veterans Affairs committee  Again, as I pointed out in my opening remarks, we look at our own ADR events that are coming in, and we look at what the literature and international regulators are doing, and what the manufacturer may be telling us. We were seeing in the reports coming in—in other jurisdictions

Veterans Affairs committee  The product monograph is a document that provides information on the indications, the use, contraindications, warnings, precautions, and side effects. It has a part two, which has information for patients, and it has a central part, which has evidence that supports the market aut

Veterans Affairs committee  Each anti-malaria prevention therapy has its own advantages and disadvantages. Compared with some of the other therapies, if you have kidney problems, if you have photosensitivity, if you have a history of allergy or cardiac problems, mefloquine may be a better choice. It's reall

Veterans Affairs committee  They're listed in the product monograph and they vary. You can go by organ system, and they're listed. They can include severe allergic reactions that can be life-threatening; they can include excessive toxicity, skin reactions, GI reactions—vomiting, and diarrhea. Malarone can c

Veterans Affairs committee  My role is to represent Health Canada. It's not the role of Health Canada to do that; the role is to provide the information effectively. Then, at the interface with the patient, that decision has to be made, and there are many considerations in that regarding, including patient

Veterans Affairs committee  The requirements and regulations under the Food and Drugs Act are that the manufacturer of a drug has a mandatory obligation to report on serious and unexpected adverse drug reactions. There is a way to voluntarily report. Users of products—physicians, hospitals, pharmacists—can

Veterans Affairs committee  That type of information would be very helpful. The mandate, as defined under the Food and Drug Act and regulations, is that Health Canada doesn't carry out research. It may support research through funding through CIHR, the Canadian Institutes of Health Research, but as far as p

Veterans Affairs committee  Thank you. Good afternoon, everyone. Thank you for the opportunity to appear today. I'm pleased to be here today to speak on the regulatory history of mefloquine. Malaria is a serious life-threatening illness. Even with modern effective treatments and intensive-care support,