Evaluation of a simplified pharmacovigilance tool for general practitioners: 5 years of insight.

Spontaneous reporting of adverse drug reactions (ADRs) is the cornerstone of pharmacovigilance. However, major underreporting exists. The main objective of this study was to assess the use of a pharmacovigilance simplified reporting tool (PSRT) by general practitioners (GPs) and, secondarily, to describe the quality of ADR reports during this period. The PSRT was proposed on June 1st, 2015, for the 1290 GPs in the Western Normandy Region. The number and quality of ADRs reported monthly by GPs were prospectively collected from June 1st, 2015, to May 31st, 2020 (Period 2), and compared to those reported during a control period (June 1st, 2010, to May 31st, 2015, Period 1). During all the periods, 920 reports were made by 307 GPs (198 reports in Period 1 and 722 reports in Period 2), with 477 reports (51.8%) using the PSRT. During Period 2, the monthly number of reports was multiplied by 3.5 (p < 0.0001), and the number of GPs was 1.4 compared to that in Period 1 (p = 0.01). Our PSRT showed effectiveness in quantitative and qualitative terms. It must now go further and be integrated into GP software to facilitate ADR reporting nationwide.

[Antidepressive agents and hypertension: A case/no-case study in French pharmacovigilance database]. / Antidépresseurs et hypertension artérielle : étude cas /non-cas dans la base nationale de pharmacovigilance.

INTRODUCTION: Drug-induced hypertension was described with several pharmacological classes. The association between hypertension and antidepressant drugs (AD) is controversial. The objective of this study was to evaluate the link between hypertension and ADs. MATERIALS AND METHODS: A retrospective disproportionality analysis from observations consecutively reported to the French pharmacovigilance database between 1985 and 2020 was performed. The relationship between the suspected ADs and the occurrence of hypertension was assessed by calculating the reporting odds ratio (ROR) in a case/non-case design. A negative (paracetamol) and a positive (celecoxib) control were used to validated this disproportionality method. RESULTS: We compared 6725 cases (including 464 AD-related cases) to 789,483 non-cases (including 56,440 AD-related cases). The reporting of hypertension was significantly associated with serotonin/norepinephrine reuptake inhibitors (SNRI) (ROR 1.43, 95 % CI 1.26-1.64) and monoamine oxidase inhibitors (MAOI) (ROR 6.41, 95 % CI 4.25-9.67) but not with other ADs classes. Concerning ADs analyzed independently of their AD class, a significant signal was observed with many SNRIs (duloxetin, milnacipran and venlafaxin) and with all MAOIs (moclobemide, iproniazide) (ROR between 2.04 and 17.93) but not with others ADs. The ROR value of positive (celecoxib) and negative (paracetamol) controls were ROR=1.53; IC95 %=1.04-2.26 and ROR=0.72; IC95 %=0.65-0.80, respectively. CONCLUSION: We found a significant association between development or worsening of hypertension and SNRIs and MAOIs but not with others ADs, in this study performed in real conditions of life. It is therefore advisable to remain cautious when prescribing ADs and to check systematically for hypertension.

Soft-tissue venous malformations in children: percutaneous sclerotherapy with Ethibloc.

Thirty-eight children with soft-tissue venous malformations (VMs) were treated with percutaneous injection of a new fibrosing agent (Ethibloc). The technique, results, side effects, and complications are detailed. Direct puncture of the VM allows evaluation of the draining venous system and direct injection of Ethibloc. This procedure alone or associated with surgery led to achievement of good or excellent results in 74% of the cases (complete cure in 50%), with minimal side effects and no major complications.

Increase of sister chromatid exchanges in excision repair deficient xeroderma pigmentosum.

The distribution of spontaneous sister chromatid exchanges (SCEs) was studied in PHA-stimulated lymphocytes from 15 patients affected by xeroderma pigmentosum (XP). The study of unscheduled DNA synthesis (UDS) in twelve of these patients showed that seven were deficient and five proficient. The number of SCEs in XP patient cells was higher than in those of 19 controls, and the distributions of SCEs per cell were significantly different. However, the results varied when XP patients were considered in relation to their UDS: the group of XP patients with proficient UDS did not differ, whereas the group of XP patients with deficient UDS was very significantly different from controls. The group not tested for UDS was similar to the deficient UDS group. The possible relationship between the increase of SCEs and the type of DNA repair defect is discussed.

Jumping translocation of chromosome 14 in a skin squamous cell carcinoma from a xeroderma pigmentosum patient.

The cytogenetic study of a case of cutaneous squamous cell carcinoma developed in a child affected by xeroderma pigmentosum is described. In this paratetraploid tumor, virtually all mitoses had the following rearrangements: i(1q), i(1p), t(3q14q), del(9p), and der(19)t(8;19). In addition, there were several deletions of 1p and 1q. The del(9p) likely occurred as the first rearrangement. The distal segment of the short arm of chromosome #9 and the long arm of #19 and #22 were the most underrepresented and chromosome #6 the most overrepresented chromosome or chromosome segment. The most striking anomaly detected was a jumping translocation of chromosome #14, involved with chromosomes #1, #3, #5, #7, #9, #14, and #22. The breakage of chromosome #14 always occurred on the short arm.