Why there is a need for pharmacovigilance.

Not everything is known about a medicine when it receives its licence for marketing. The merits of a new drug, balancing its beneficial and its untoward effects, become only established after sufficient experience has been gained from its use in real practice. Part of the reason for this is that our extensive phase III clinical trials fail to detect some side-effects.

Coming full circle in pharmacovigilance: communicating safety information to patients through patient package inserts.

Optimal drug therapy requires that the patient should be informed adequately, unequivocally and in timely fashion. Patient package inserts (PPIs) have an important facilitating role to play in this respect. Patients' confidence in the benefit of a drug treatment and their fear of its side effects are strong determinants of their adherence to that treatment.

Post-marketing cohort study comparing the safety and efficacy of flunarizine and propranolol in the prophylaxis of migraine.

A comparative post-marketing surveillance study of the safety and efficacy of flunarizine and propranolol in the treatment of migraine was carried out. General practitioners in Belgium and the Netherlands each recruited patients for whom they would prescribe one of the study medications in the normal course of their treatment and recorded all medical events on follow-up forms for up to 8 months. A total of 1601 migraine patients were enrolled; 838 in the flunarizine cohort and 763 in the propranolol cohort.