That I would perhaps defer to a physician and their code of conduct.
I would speak to mandatory reporting from industry, because there is at least some obligation on industry to report now, although I believe it's only in a very serious event. But I believe the physician should inform the patient that there might be a problem with this drug and deal with it, and they should probably have to report to their professional association, and if it's aware of this drug causing problems, they should report to Health Canada as well.