Dolutegravir and neural tube defects: a new insight Chouchana, Laurent; Pariente, Antoine; Pannier, Emmanuelle ...
The Lancet infectious diseases,
April 2020, 2020-Apr, 2020-04-00, 20200401, Volume:
20, Issue:
4
Journal Article
Peer reviewed
Dolutegravir is a highly effective antiretroviral therapy (ART) allowing a fast viral load decrease, which is promising in low-income and middle-income countries.1 However, according to preliminary ...results from a nationwide birth surveillance programme in Botswana,2 it has been associated with the development of neural tube defects in newborn babies. A review of neural tube defect cases has also been done on pharmacovigilance databases; however, this review lacks data on dolutegravir exposure in pregnant women necessary to make any conclusion.6 To provide additional information, we analysed the reporting of neural tube defects in the WHO pharmacovigilance database (VigiBase). The association can be expressed using the odds ratio (OR) of reporting, which shows the advantages of this measure in the detection of safety signals.9 To shorten possible indication bias, our analysis was restricted to individual case safety reports related to adult women—ie, aged 18–64 years according to VigiBase classes—and when patient sex was not reported, related to adverse events in the spectrum of congenital disorders.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
32.
Digital Ischemia Induced by Fesoterodine Cosse, Cyril; Chaigne, Benjamin; Plaisant, Siguine ...
Journal of clinical rheumatology,
09/2021, Volume:
27, Issue:
6
Journal Article
Given the high prevalence of antibiotic prescription during pregnancy in France and previous studies suggesting an increased risk of infection in offspring with such exposures, our study aimed to ...investigate the association between prenatal exposure to systemic antibiotics and serious infections in full-term infants during their first year of life.
We conducted a retrospective population-based cohort study on singleton, full-term liveborn non-immunocompromised infants, using the French National Health Data System (SNDS) between 2012 and 2021. Systemic antibiotic dispensing in ambulatory care settings during pregnancy defined the exposure. Outcomes concerned serious infections (i.e., infections requiring hospitalization) in offspring identified between 3 and 12 months of life, hence excluding infections of maternal origin. Adjusted odds ratios (aORs) were estimated using logistic regression with multivariate models to control for potential confounders.
Of 2,836,630 infants included, 39.6% were prenatally exposed to systemic antibiotics. Infants prenatally exposed to antibiotics had a higher incidence of serious infections compared with unexposed infants {aOR 1.12 95% confidence interval (95% CI) 1.11-1.13}. Similar associations were observed according to the timing of exposure during pregnancy, antibiotic class, and site of infections. The strongest association was observed when infants were prenatally exposed to three or more antibiotic courses during pregnancy aOR 1.21 (95% CI 1.19-1.24). Limitations include residual confounders, such as genetic susceptibility to infections and the role of the underlying pathogen agent.
Prenatal exposure to systemic antibiotics is very common and is associated with a weak yet significant associations with subsequent serious infectious events during the first year of life. While our study revealed associations, it is important to note that causation cannot be established, given the acknowledged limitations, including potential confounding by indication.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Several cases of herpes zoster (HZ) following mRNA COVID‐19 vaccination (BNT162b2 and mRNA‐1273) have been reported, and the first epidemiological evidence suggests an increased risk. We used the ...worldwide pharmacovigilance database VigiBase to describe HZ cases following mRNA COVID‐19 vaccination. We performed disproportionality analyses (case/non‐case statistical approach) to assess the relative risk of HZ reporting in mRNA COVID‐19 vaccine recipients compared to influenza vaccine recipients and according to patient age. To 30 June 2021, of 716 928 reports with mRNA COVID‐19 vaccines, we found 7728 HZ cases. When compared to influenza vaccines, mRNA COVID‐19 vaccines were associated with a significantly higher reporting of HZ (reporting odds ratio 1.9, 95% CI 1.8–2.1). Furthermore, we found a reduced risk of reporting HZ among under 40‐year‐old persons compared to older persons (reporting odds ratio 0.39, 95% CI 0.36–0.41). Mild and infrequent HZ reactions may occur shortly after mRNA COVID‐19 vaccination, at higher frequency than reported with influenza vaccination, especially in patients over 40 years old. Further analyses are needed to confirm this risk.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
BRAF inhibitors (BRAFi) and MEK inhibitors (MEKi) significantly improved metastatic melanoma prognosis. Ocular adverse effects (OAEs) represent an uncommon but disabling toxicity of these drugs. We ...aimed to characterize the ocular safety profile of BRAFi or MEKi and to detect possible safety signals.
We performed a retrospective, observational, pharmacovigilance study using VigiBase, the World Health Organization global safety database. Ocular adverse effects were classified according to the eye segments and the inflammatory pattern based on the Standardization of Uveitis Nomenclature. Associations among BRAFi monotherapy, MEKi monotherapy, and BRAFi+MEKi combination therapy and OAE reporting were assessed using disproportionality analysis. Results were expressed with the reporting odds ratio (ROR) and its 95% confidence interval (CI).
From January 2010 to October 2019, 1568 OAE cases were reported with BRAFi or MEKi. Among them, 1006 cases with sufficient data were included, corresponding to 310 (30.8%), 124 (12.3%), and 572 (56.9%) cases reported with BRAFi, MEKi, or BRAFi+MEKi combination therapy, respectively. BRAF inhibitor monotherapy was significantly associated with the reporting of iris and ciliary body abnormalities (ROR, 8.7; 95% CI, 6.0-12.5), diffuse abnormalities (ROR, 7.1; 95% CI, 5.4-9.4), anterior uveitis (ROR, 8.6; 95% CI, 6.0-12.1), and panuveitis (ROR, 7.1; 95% CI, 5.4-9.4). MEK inhibitor monotherapy was associated with the reporting of retinal and choroid abnormalities (ROR, 9.5; 95% CI, 7.4-12.2), diffuse abnormalities (ROR, 2.5; 95% CI, 1.1-6.1), and panuveitis (ROR, 2.5; 95% CI, 1.1-6.1). Combinations of BRAFi and MEKi therapies were associated with OAEs from both drugs, with a possible synergistic or additive effect for diffuse abnormalities and panuveitis.
Our study characterizes the ocular safety profile of BRAFi and MEKi. We identify possible safety signals for several OAEs not previously reported with BRAFi and MEKi. Our data provide the rationale for a personalized management of OAE in patients with BRAFi+MEKi combination therapy according to the type of ocular reaction.
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