The PREGVAXGRIP study: a cohort study to assess foetal and neonatal consequences of in utero exposure to vaccination against A(H1N1)v2009 influenza.

BACKGROUND: In October 2009, in the context of an A(H1N1)v2009 influenza pandemic, a vaccination campaign was launched in France, in which one of the priority groups was pregnant women, on account of the high risk of developing complications following infection by this virus. OBJECTIVE: The aim of this multicentric, prospective, observational study was to assess safety and pregnancy outcomes in a cohort of pregnant women when receiving the A(H1N1)v2009 influenza pandemic vaccine. METHODS: This was a prospective study that followed up pregnant women recruited mainly in vaccination centres and maternity departments. Following the expected delivery date, follow-up data were collected concerning the delivery, the infant, and, if appropriate, the reasons why the pregnancy did not reach its term. RESULTS: Between 1 November 2009 and 31 March 2010, 2,415 pregnant women were included at the time of vaccination; 97.6 % of women received a vaccine without adjuvant and 2.4 % received an adjuvanted vaccine. Ninety-two (3.9 %) women were vaccinated during the first trimester of pregnancy, 1,090 (46.5 %) during the second trimester, and 1,162 (49.6 %) during the third trimester. One hundred and thirty-three adverse events (5.5 % of women) were reported, of which 12 were unexpected or serious. There were 2,246 (93.0 %) known pregnancy outcomes with 12 spontaneous abortions (0.5 %), 6 stillbirths (0.3 %), and 4 therapeutic abortions (0.2 %). There were 65 neonates with congenital anomalies, among which 31 were major. But only one congenital malformation (1.4 %) was reported for the 92 women vaccinated in their first trimester. Of the women, 93.3 % were delivered full term and 6.7 % preterm. For 96 (4.2 %) neonates, a disorder was reported in the neonatal period and 130 (5.6 %) were transferred to the neonatology department. CONCLUSIONS: This study suggests that exposure to the A(H1N1)v2009 pandemic influenza vaccine during pregnancy does not increase the risk of adverse pregnancy outcomes. However, because of the relatively small number of women exposed during the first trimester, other studies are needed to exclude an increased risk of malformation.

[Dementia syndrome in an elderly subject related to valproic acid use: a case report]. / Syndrome démentiel du sujet âgé lié à un traitement par acide valproïque: à propos d'un cas.

In addition to the usual adverse effects, the chronic use of the valproic acid can entail dementia syndrome. We describe the case of a 68-year-old woman who had presented a dementia syndrome due to the use of valproic acid for one year. This drug was prescribed in order to prevent a potential convulsive crisis after an ischemic stroke in a patient who did not have a history of epilepsy. This case shows that each clinician must be careful about all medications consumed by the patient in the face of cognitive disorders.

[Identification of drug misuse. Study of spontaneous notifications of adverse drug events in a regional safety reporting centre]. / Identification du mésusage des médicaments. Etude de la notification spontanée des effets indésirables dans un centre régional de pharmacovigilance.

INTRODUCTION: The misuse of drugs, common practice for some, is a source of iatrogenic diseases and considerable supplementary costs in hospital budgets. The aim of this study was to quantify the number of adverse events (AE) related to the misuse of drugs. METHODS: This was a study conducted on 200 new validated AE case reports. In each report, we searched for the drug(s) responsible and checked whether the prescription respected the SPC (summary of product characteristics) and current guidelines or not. RESULTS: Among the 200 reports, 49 (24.5%) cases of AE were related to the misuse of a drug in 46 patients, with a mean age of 65.8 years [24 to 97]. Among these cases, 33 (67.3%) were at the origin of hospitalisation or prolongation of the latter. In 17 cases (34.7%), there was no therapeutic alternative to the drug used in the framework of misuse. DISCUSSION: The notion of good or bad use of a drug progresses with the life of the drug. We therefore selected as criterion of misuse the non-respect of the SCP but also other guidelines. Regarding the cases that could have been avoided, these concerned an AE related to poor surveillance and assessment of the benefit/risk ratio of treatments prescribed to elderly patients and also the commonplace use of non-steroidal anti-inflammatories, at the origin of digestive haemorrhages. CONCLUSION: The prevention of misuse implies all the actors of the health system. A reassessment of the prescription of certain therapeutic classes of drugs would avoid a great number of iatrogenic accidents and would lead to considerable economy in the field of health.