[Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database]. / Troubles psychiatriques associés au montélukast : données de la base nationale de pharmacovigilance.

Montelukast (Singulair(®)) has been the subject of post-marketing warnings about psychiatric events occurring that had not been identified during clinical trials. The objective of this study was to take stock of the adverse events (AEs) related to montelukast reported in France. Cases of psychiatric disorders reported to regional pharmacovigilance centers (CRPV) and the literature data were analyzed. The 56psychiatric AEs account for 20% of all AEs reported in the montelukast CRPV: essentially sleep disorders, behavioral disorders and depression. This risk is also found in pharmacovigilance databases in other countries, especially in the North American database, which recorded a significant number of cases of "suicidality", including suicidal ideation, suicide attempts, and suicides. Analysis of clinical efficacy studies have failed to confirm these AEs. The potential severity of these events prompts physicians to seek the existence of psychiatric disorders before prescribing the drug and to carefully monitor the occurrence of AEs during treatment.

[Pharmacovigilance in children]. / Pharmacovigilance en pédiatrie.

Drug safety in children must take into account the frequency of « off label ¼ prescriptions, children's growth dynamics, and possible long-term consequences (growth, neurodevelopment). The pharmacovigilance methodology is based on spontaneous notification and pharmacoepidemiology studies usually included the in risk management plan. Despite an increased drug risk (pharmacokinetic and pharmacodynamic specificities), drug safety is better in children than in adults. The incidence of drug side effects depends on the country, the type of study (in or out of the hospital), and age. Antibiotics, central nervous, respiratory and dermatologic drug systems are most often involved. The target organs are gastrointestinal and neurologic. In neonates, the most frequent side effects are due to pregnancy exposure to psychotropic drugs, beta-blockers, and antiepileptics. Some studies have shown an increased risk of off-label prescriptions in children. During the last 6 years in France, pediatric alerts (desmopressin, metoclopramide, bronchial mucolytic drugs, first-generation anti-H1, Uvesterol D(®), and Uvesterol A.D.E.C(®), rotavirus vaccines, growth hormone, cisapride) have been less frequent than in adults.