Sleep and mood changes in advanced age after blue-blocking (yellow) intra ocular lens (IOLs) implantation during cataract surgical treatment: a randomized controlled trial.

Objectives: Both advanced age and depression are characterized by changes in sleep patterns. Light exposure is one of the main synchronizers of circadian cycles and influences sleep by inhibiting melatonin secretion, which is mostly sensitive to light of low wavelengths (blue). Blue-blocking (yellow) intraocular lenses (IOLs) have supplanted the usual UV-blocking (clear) IOLs during cataract surgery to prevent age-related macular degeneration, however, the impact of yellow IOLs on sleep and mood is unclear.

[Hydroxychloroquine during pregnancy: a review of retinal toxicity in the newborns].

Objective: The objective of this study is to review the published data on ocular toxicity in newborns after in utero exposure to hydroxychloroquine.

Methods: All publications related ophthalmologic follow-up of newborns or infants who were exposed to hydroxychloroquine during pregnancy were selected.

Results: Nine studies were analyzed, concerning 246 infants for which an ophthalmological examination was available.

[Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database].

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.

[Pharmacovigilance in children].

Drug safety in children must take into account the frequency of « off label » 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.

[Neonatal risks of drugs exposure at the end of pregnancy].

Foetal drugs exposure consequences depend according to the drug involved and to the length of the exposure which in the sum of length of treatment and of drug elimination (5 half life). Decisions are based upon risk evaluation and are a compromise between a risk banalisation and an excess of carefully. We described risks management for drugs used for a disease due to the pregnancy (glucocorticoïdes, antibiotics) then for drugs used for a chronic disease often preceding the pregnancy (non steroidal anti-inflammatory, serotonin recapture inhibitors, benzodiazepines, antiepileptics, conversion enzyme inhibitors/renine angiotensine antagonists, betabloquants).

Drug exposure during the periconceptional period: a study of 1793 women.

Background: Many studies have described the prescribing of drugs to pregnant women, but only very few have data concerning the periconceptional period specifically.

Aim: The aim of the study was to evaluate the incidence of exposure to teratogenic drugs during early pregnancy and to determine whether a safer drug exists.

Methods: In a French health insurances database, we analyzed drugs prescribed during the period starting 1 month before and ending 2 months after the beginning of pregnancy between 1 January 2006 and 31 December 2007.

[Adverse drug reactions of strontium ranelate(Protelos(®) in France].

Objective: Study of side effects (SE) associated with strontium ranelate required by the French Drug agency (Afssaps).

Method: SE associated with strontium ranelate and spontaneously reported until March 2009 to the manufacturer or to the French Regional Pharmacovigilance Centers and the periodic safety reports have been analyzed. Utilisation and sales data have been obtained from the manufacturer.

Risk of ST versus non-ST elevation myocardial infarction associated with non-steroidal anti-inflammatory drugs.

Objective: The objective of this study was to explore the association of non-steroidal anti-inflammatory drugs (NSAID) with ST-segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (NSTEMI).

Design, Setting & Patients: A matched case-control study comparing patients with incident non-fatal myocardial infarction (MI) collected by cardiologists with controls. Cases were retrieved from the Pharmacoepidemiological General Research on Myocardial Infarction (PGRx-MI) registry, a French nationwide registry consisting of 55 cardiology centres, whereas controls were selected from general practice settings.

Heptavalent pneumococcal conjugate vaccine (PCV7): French survey of serious adverse reactions.

Purpose: Previous study did not reveal any particular heptavalent pneumococcal conjugate vaccine (PCV7) related risk. However, french drugs agency (Afssaps) requested the continuation of its surveillance.

Methods: All serious PCV7-related adverse drug reactions spontaneously reported between October 1, 2004 and December 31, 2007 to the French pharmacovigilance centers or to Wyeth Pharmaceutical France were included.

[The use of postnatal corticosteroid therapy in premature infants to prevent or treat bronchopulmonary dysplasia: current situation and recommendations].

In the last few years, several studies related to the benefit/risk balance of postnatal corticosteroids administered to premature neonates for prevention or treatment of bronchopulmonary dysplasia (BPD) have been published. These data encourage caution, given the risk of long-term adverse neurodevelopmental outcomes. In the meantime, the clinical profile of BPD has been altered based on the progress made in the pre- and postnatal care of premature infants.

Isotretinoin exposure during pregnancy: assessment of spontaneous reports in France.

Background: In three previous studies, we have shown that pregnant women were still being exposed to isotretinoin and that compliance with recommendations was incomplete. The relaxation of these recommendations (summary of product characteristics 2004), combined with the release of generic brands, encouraged us to carry out a fourth study.

Objective: To assess isotretinoin exposure during pregnancy following the application of less stringent recommendations and the marketing of generic isotretinoin brands.

[Most innovative drugs labelled during the last years in paediatrics: does the paediatrician have the tools for their identification?].

When a new drug is labelled, before deciding its integration in the therapeutic strategy, the doctor has to know the degree of innovation of the drug, i.e. its actual benefit and the improvement of actual benefit, also called added value over other available drugs.

[Adverse reactions of atazanavir, fosamprenavir and tipranavir in "real life"].

Objective: To precise adverse effects of atazanavir, fosamprenavir and tipranavir "in real life".

Method: Descriptive study of 3 protease inhibitor adverse effects stored in the French Bank of Pharmacovigilance.

Results: Nineteen adverse effects having at least possible links with antiretroviral drugs studied were reported.

Clinical features and risk factors for upper gastrointestinal bleeding in children: a case-crossover study.

Objective: This population-based survey was conducted to provide a formal description of upper gastrointestinal bleeding (UGIB) in children on a nationwide basis and assess the contribution of risk factors, principally nonsteroidal anti-inflammatory drugs (NSAID).

Methods: A case-crossover study of UGIB patients aged between 2 months and 16 years was conducted in France. Medical data were collected by physicians, and personal risk factors and exposure to drugs during the month preceding the onset of the bleeding was ascertained by a standardised telephone interview with parents.

Drug dependence associated with triptans and ergot derivatives: a case/non-case study.

Introduction: The aim of this case/non-case study was to assess and compare the risk of drug dependence associated with different migraine-specific drugs, i.e., ergot derivatives and triptans, using the French pharmacovigilance database.