Yes, they are. When there is a report for an adverse drug reaction, that report is not related to whether the drug was used within the approved indication or off-label.
It's also interesting that internationally and also in Canada we are moving to a life cycle approach. Basically, the concept is that more and more drug manufacturers will be expected, at the time of approval, to submit information about potential off-label use, whether it's in pediatrics or other subpopulations, and to document or to monitor such off-label use.
In the life cycle approach, the thinking behind it--the same thinking is present also in Europe, for example, where they use the risk management plan--is that whenever you submit a drug, you also have to assess the potential for off-label use, monitor that off-label use, and report that to the regulatory authorities.