An important consideration is how quickly information needs to be made available to users. A new life-threatening adverse reaction, such as cardiac arrhythmias with terodiline (Rawlins, 1997), requires immediate communication, whereas the addition of a symptom which does not appear to be associated with serious consequences (e.g. nausea) to the undesirable effects section of the product information could be actioned at the next routine revision. Furthermore, in the latter case there may be no particular need to draw attention to the problem. Most issues come between these two extremes and a judgement needs to be made about the speed of action and the most appropriate method of communication.
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