A 13-Year National Monitoring Study to Assess Narcotic Prescriptions and Indications (2007–2019)

Drug Safety - Analgesics are among the most widely used drugs worldwide. This study describes the population treated with narcotic analgesics, their therapeutic indications and how the data have...     

Épidémiologie et pharmacoépidémiologie du purpura thrombopénique immunologique

During the last decade, the development of large clinical and population-based cohorts led to new findings in the epidemiology and the pharmacoepidemiology of immune thrombocytopenia (ITP). The incidence is estimated to 3–4 for 10⁵ inhabitants/year, with a slight female predominance and peaks in children and patients after 60 years. The incidence rate is 9 for 10⁵ inhabitants/year in males after 75 years. Variations across ethnic groups are discussed. In France, there is a North-South gradient and a peak of incidence during winter suggesting the role of viruses in ITP pathophysiology. Myelodysplastic syndromes are an emergent cause of secondary ITP. The incidence of intracranial bleeding is about 1% by year and the risk increases with aging. Exposure to splenectomy decreases while rituximab and thrombopoietin receptor agonists (TPO-RA) are the most used second-line drugs for persistent ITP. Mortality is slightly increased in primary ITP as compared with the general population. ITP patients have an increased risk of infection, thrombosis and hemorrhage. Aging, lung diseases, splenectomy, corticosteroids and rituximab are risk factors for infection while influenza and pneumococcal vaccines are associated with a 50% decrease of infection risk. Aging, cardiovascular risk factors, lupus anticoagulant and splenectomy are risk factors for thrombosis. The risk of thrombosis associated with corticosteroids and TPO-RAs must be further investigated.     

Calcium inhibiting drugs and the risk of gastrointestinal hemorrhage. A pharmaco-epidemiologic case-non-case study]

Calcium antagonists were found to be associated with an increased risk of gastrointestinal haemorrhage (GIH) in hypertensive patients over 67 years old (Pahor et al. Lancet 1996; 347 : 1061). This unexpected result led us to investigate this question using the French pharmacovigilance system database. We use the case/non case methodology (Moore et al. Br J Pharmacol 1997; 44 : 513) where cases and non cases were both identified from the spontaneous adverse drug reaction (ADR) reporting database. Cases were reports of the reaction of interest (i.e. GIH as recorded in the database). Non cases were all reports of reactions other than being studied. Exposure was considered as the presence in a report of the drug of interest (calcium antagonists), whether or not it was suspected of causing the reaction. We calculated Odds ratios (OR) as the ratio of the Odds of the association of reports of GIH with calcium antagonists in cases and in non cases. Calcium antagonists included in the present study were dihydropyridines, diltiazem, verapamil and bepridil. Salicylates and non steroidal antiinflammatory drugs were used as positive controls. Among the 112,792 ADRs recorded in the database between January 1985 and December 1996, 864 (0.8%) were GIH. There was no association between GIH and the exposure to calcium antagonists whatever the class of the drugs (OR = 1.2, 95% CI: [0.9; 1.6]. A subgroup analysis among the GIH reported in patients over 65 years old (470 GIH from 37,462 ADRs) also failed to find any association (OR = 0.7, 95% CI: [0.5-1.0%]). The present results failed to confirm the hypothesis of an association between GIH and use of calcium antagonists.