There is a requirement that the patient information leaflet should contain warnings about the possible adverse side-effects of the medicine. The noble Lord is quite right that data may well have arisen from the clinical trials, but also from the yellow card reporting system, as it is called, and any other data that emerge from across the world. The point is to ensure that the
patient is properly informed. No medicine is risk-free. All medicines carry some kind of risk of a side-effect and one has to recognise that that is part and parcel of the benefit that we get from medicines. The benefit-risk equation has of course to be positive, but these things need to be kept under scrutiny.
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