Suicide, suicidal thoughts and self-harm
5.2.2 The Group was informed that the MAH has conducted further analysis of their clinical trials data to examine:
5.2.4 The Group commented that this was contrary to the data from clinical trials where paroxetine was compared with an active comparator. In these studies the incidence of suicide-related events in young adults treated with paroxetine was lower than that in the active comparator group, but this was not sufficiently reassuring given that this may indicate that the problem may be worse with other active comparators. The Group commented that it would be important to obtain data on efficacy of paroxetine in young adults.