I can speak generally to how we regulate, whether in the case of antibiotics or other kinds of therapeutic products. I can't speak, without consulting my colleagues back in the department, to the specifics of this particular compound you're talking about. As a general rule, for many of the products we regulate there is a risk profile. Even products that are well known and widely used will present some risks, and there are some individuals who can have an adverse reaction or a bad outcome.
When we regulate and we look at the clinical trial data and gather up all the evidence needed to make a decision, there is frequently a calculus of whether the benefits of the product outweigh the risks.
In the case of a product such as the one you're discussing, which has received a Health Canada approval, there is a judgment about whether the product actually confers a benefit even though there may be risks associated with it. Ideally, you want to make sure that the risks are well understood and well characterized and that they're on the product monograph, so that when physicians are prescribing and patients are using it, they have a really good understanding of the risks.
As you would know, presumably, when taking medication you sometimes look at the monograph, and it will lay out the various risks.
What I will say is that when new risks come to our attention after a product is on the market, or when risks that we once thought were perhaps less serious turn out to be more serious, post-market surveillance is done. We do follow up, and when there might be evidence that the risks are serious or some new risk has been identified, we will often take a second look. We'll have an expert panel that might—