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 as well as in Canada—the description of the severe events, and also the point that these persisted after the drug was stopped. To sort it out ultimately and do a causality assessment to determine whether the product is causing or directly related to the symptoms the patient is describing is a very challenging type of work to do and to determine, because many different factors are involved.
For instance, depression is a diagnosis that happens in individuals who aren't on medication and for those who are on medication. If depression occurs while you're taking a medication and then continues, the medication may be playing a role. But there may be other psychosocial factors and genetic factors involved. We know that mental illness happens in the population that isn't on medication, so it's often challenging to say, when someone makes a report, that there's a direct causal relationship with the medication. But when we're seeing a number of reports, then we will look at the labelling and see whether it should be in there to alert physicians that this may have a role.
Some of the reports of adverse events with neuropsychiatric symptoms said that the symptoms persisted afterwards. It's not clear whether that's been caused by the medication, but it's there, so it's in the monograph to alert practitioners that this is something to consider when they're thinking of prescribing the drug.