Acute Pancreatitis Occurring after Pamidronate Infusions in Two Patients with Spondyloarthritis

We report two cases of acute pancreatitis following the administration of pamidronate given as an anti-inflammatory agent for spondyloarthritis with a recurrence in one patient when the drug was reintroduced. The upper gastrointestinal toxicity of aminobisphosphonates is well known and this drug class could be added to the list of medications that are associated with the development of pancreatitis

Sudden Sensorineural Hearing Loss after COVID-19 Vaccination: A Review of the Available Evidence through the Prism of Causality Assessment

Sudden sensorineural hearing loss (SSNHL), a rare audiological condition that accounts for 1% of all cases of sensorineural hearing loss, can cause permanent hearing damage. Soon after the launch of global COVID-19 vaccination campaigns, the World Health Organization released a signal detection about SSNHL cases following administration of various COVID-19 vaccines. Post-marketing studies have been conducted in different countries using either pharmacovigilance or medico-administrative databases to investigate SSNHL as a potential adverse effect of COVID-19 vaccines. Here, we examine the advantages and limitations of each type of post-marketing study available. While pharmacoepidemiological studies highlight the potential association between drug exposure and the event, pharmacovigilance approaches enable causality assessment. The latter objective can only be achieved if an expert evaluation is provided using internationally validated diagnostic criteria. For a rare adverse event such as SSNHL, case information and quantification of hearing loss are mandatory for assessing seriousness, severity, delay onset, differential diagnoses, corrective treatment, recovery, as well as functional sequelae. Appropriate methodology should be adopted depending on whether the target objective is to assess a global or individual risk

Acute Pancreatitis Occurring after Pamidronate Infusions in Two Patients with Spondyloarthritis

We report two cases of acute pancreatitis following the administration of pamidronate given as an anti-inflammatory agent for spondyloarthritis with a recurrence in one patient when the drug was reintroduced. The upper gastrointestinal toxicity of aminobisphosphonates is well known and this drug class could be added to the list of medications that are associated with the development of pancreatitis

Point sur les vaccinations à risque pendant la grossesse

Pendant la pandémie de grippe A, l’utilisation de la vaccination chez la femme enceinte a suscité beaucoup d’interrogations. Les épidémies, la facilité de voyager, la couverture vaccinale insuffisante, exposent ces patientes à des infections pouvant avoir des conséquences graves sur la grossesse et le futur enfant. Le principe de précaution prévalant chez la femme enceinte, il est essentiel de mesurer le risque épidémiologique de la maladie, afin d’éviter la survenue d’évènements indésirables. L’administration vaccinale prophylactique contre certaines infections doit être évaluée avec prudence, en raison du nombre réduit de données disponibles. Elle dépendra de la nature du vaccin, de ses effets indésirables, du stade de la grossesse, du bénéfice apporté à la mère et au futur nouveau-né, et des antécédents cliniques maternels. Quelle que soit la nature du vaccin administré, l’interruption de la grossesse n’est pas justifiée ; son évolution devra être surveillée afin de déceler la survenue de complications

COVID-19 vaccines surveillance in France: a global response to a major national challenge

International audienceNo abstract availabl

Therapie

INTRODUCTION: Two severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines, tozinameran/BNT162b2 (Comirnaty®, Pfizer-BioNTech) and elasomeran/mRNA-1273 (Spikevax®, Moderna), were approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) at the end of 2020, less than a year after the start of the coronavirus disease 2019 (COVID-19) pandemic. In France, the health authorities have requested an intensive vaccination campaign, accompanied by a reinforced and active pharmacovigilance surveillance. This surveillance and analysis of real-life data, based on spontaneous reports received by the French Network of Regional PharmacoVigilance Centers (RFCRPV), has enabled to identify numerous pharmacovigilance signals. Some of them, such as myocarditis and heavy menstrual bleeding, have been confirmed as adverse effects of these vaccines. METHOD: We propose a descriptive review of the main pharmacovigilance signals identified by the RFCRPV concerning vaccines from the mRNA platform. RESULTS: Most pharmacovigilance signals were common to both mRNA vaccines: myocarditis, menstrual disorders, acquired haemophilia, Parsonage-Turner syndrome, rhizomelic pseudo-polyarthritis and hearing disorders. Other signals were more specific, such as arterial hypertension with tozinameran or delayed reaction site injection with elasomeran. CONCLUSION: This non-exhaustive review illustrates the experience of RFCRPV in identifying and monitoring pharmacovigilance signals related to mRNA vaccines in France during the COVID-19 pandemics, and the crucial role of pharmacological and clinical expertise in this area. It also highlights the predominant contribution of spontaneous reporting in the generation of pharmacovigilance signals, particularly for serious and rare adverse events not detected before marketing

Médicaments et chaleur : étude SIRIUS cas-témoins multicentrique chez les sujets de plus de 65 ans durant l'été 2007 en France

Objectif : Évaluer les médicaments responsables d'effets indésirables liés à la chaleur. 
Méthodes : Nous avons effectué une étude cas-témoin multicentrique (Toulouse, Besançon, Marseille) incluant 36 cas (patients de plus de 65 ans hospitalisés pour hyperthermie ou déshydratation sévère entre le 1er juillet et le 31 août 2007) et 51 témoins appariés. Nous avons comparé les médicaments consommés et leur adaptation posologique en fonction de la valeur de la fonction rénale. 
Résultats : Les cas prenaient plus de médicaments que les témoins (4,3 vs. 3,9; p < 0,001), en particulier des neuroleptiques (3,6 % vs. 0,5 % ; p = 0,007). À l'inclusion, la clairance de la créatinine était disponible pour seulement 12 patients (moyenne : 31,6 mL/min). 
Conclusion : Malgré son manque de puissance, cette étude montre que les patients souffrant de déshydratation pendant l'été sont ceux avec une fonction rénale altérée, prenant plus de médicaments (en particulier des neuroleptiques). La réalisation de ce travail pilote devrait permettre d'améliorer la méthodologie d'études ultérieures en cas de vague de canicule

Drugs and Sleep Apneas? A review of the French Pharmacovigilance database

The present work reviews the case reports of drug-induced sleep apnea recorded in the French pharmacovigilance database. Notifications are very rare (around 1/100 000 notifications). This paper shows that sleep apnea can be aggravated or revealed by some drugs. Main drugs involved were psychotropics (benzodiazepines, neuroleptics) and opioids