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Article ; Online: Reply to "Interpretation of Pharmacovigilance Disproportionality Analyses".

Prontskus, Viktoryia / Fresse, Audrey / Yelehe, Mélissa / Beurrier, Mathilde / Gillet, Pierre

2023 Volume 114, Issue 4, Page(s) 747

MeSH term(s)	Humans ; Pharmacovigilance ; Adverse Drug Reaction Reporting Systems ; Databases, Factual
Language	English
Publishing date	2023-06-01
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.2950
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Article ; Online: Profile of adverse drug reactions reported via the Continuum+ platform: Results from three-year regional follow-up.

Henry, Juliette / Fresse, Audrey / Beurrier, Mathilde / Antoine, Marie-Lauren / Gillet, Pierre

Therapie

2024

Abstract: In 2017, the Continuum+ platform was launched to provide a monitoring solution to home-based cancer care patients: AKO@dom monitoring. This platform also offers the follow-up of adverse drug reactions (ADRs) via direct notification to regional centers of ...

Abstract	In 2017, the Continuum+ platform was launched to provide a monitoring solution to home-based cancer care patients: AKO@dom monitoring. This platform also offers the follow-up of adverse drug reactions (ADRs) via direct notification to regional centers of pharmacovigilance (RCPVs). According to previous studies, the AKO@dom monitoring has successfully maintained treatment at the maximum effective dosage, managing ADRs and patient satisfaction. However, on the pharmacovigilance side, opinions are more divided. Due to the launch of the AKO@dom-PICTO experimentation in December 2021, in which our RCPV takes part, and to provide more data on pharmacovigilance, we decided to conduct a descriptive analysis of cases reported to our RCPV via the Continuum+ platform between 2019 and 2022. During these three years, we analyzed 1070 events, corresponding to 37 patients. Patients were primarily women (74.8%) aged around seventy with breast cancer. The most used drugs were tyrosine kinase inhibitors: palbociclib (29.7%), axitinib (16.2%), and cabozantinib (13.2%). Patients had an average of 8 ADRs, including one serious and/or unexpected ADR. Although the Continuum+ platform makes it possible to considerably limit under-reporting in pharmacovigilance, it has shortcomings. The lack of medical elements and context in notifications is a massive problem for analyzing pharmacovigilance reports. Improved access to the platform's medical information for RCPVs and pharmacovigilance training for healthcare professionals would make Continuum+ a helpful tool in pharmacovigilance.
Language	English
Publishing date	2024-04-10
Publishing country	France
Document type	Journal Article
ZDB-ID	603474-3
ISSN	1958-5578 ; 0040-5957
ISSN (online)	1958-5578
ISSN	0040-5957
DOI	10.1016/j.therap.2024.04.001
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Article ; Online: Adverse drug reaction profile of third-generation smallpox vaccines used in France during the 2022 monkeypox epidemic.

Fresse, Audrey / Massy, Nathalie / Fournier, Dorine / Pinel, Sylvine / Beurrier, Mathilde / Antoine, Marie-Lauren / Petitpain, Nadine / Gillet, Pierre

AIDS (London, England)

2024 Volume 38, Issue 5, Page(s) 768–771

Abstract: Due to the start of the monkeypox epidemic in 2022, we retrospectively analyzed the adverse drug reactions (ADRs) reported in France after monkeypox vaccinations with the third-generation smallpox vaccine. Ninety-eight cases, representing 172 ADRs, were ... ...

Abstract	Due to the start of the monkeypox epidemic in 2022, we retrospectively analyzed the adverse drug reactions (ADRs) reported in France after monkeypox vaccinations with the third-generation smallpox vaccine. Ninety-eight cases, representing 172 ADRs, were reported. ADRs were mostly expected reactogenicity reactions occurring within days after the first dose of vaccine and having a quick favorable outcome. Unexpected facial palsy and vaccination failure are discussed.
MeSH term(s)	Humans ; Smallpox Vaccine/adverse effects ; Mpox (monkeypox)/epidemiology ; Smallpox/epidemiology ; Smallpox/prevention & control ; Retrospective Studies ; HIV Infections ; Vaccination/adverse effects ; France/epidemiology
Chemical Substances	Smallpox Vaccine
Language	English
Publishing date	2024-03-14
Publishing country	England
Document type	Journal Article
ZDB-ID	639076-6
ISSN	1473-5571 ; 0269-9370 ; 1350-2840
ISSN (online)	1473-5571
ISSN	0269-9370 ; 1350-2840
DOI	10.1097/QAD.0000000000003838
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Zs.A 2228: Show issues

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Article ; Online: Drug-induced radiation recall reactions and non-anticancer drugs: A descriptive analysis from VigiBase®.

Aubin-Beale, Eyrian / Giorgi, Lorene / Beurrier, Mathilde / Granel-Brocard, Florence / Gillet, Pierre / Fresse, Audrey

Fundamental & clinical pharmacology

2023 Volume 37, Issue 3, Page(s) 673–679

Abstract: Radiation recall reactions are inflammatory reactions confined to previously irradiated tissues, often of drug-induced etiology, particularly with anticancer therapies. Other drugs, in particular COVID-19 vaccines, may also be involved. To describe ... ...

Abstract	Radiation recall reactions are inflammatory reactions confined to previously irradiated tissues, often of drug-induced etiology, particularly with anticancer therapies. Other drugs, in particular COVID-19 vaccines, may also be involved. To describe radiation recall reactions under non-anticancer drugs more precisely, we extracted the cases of radiation recall reactions associated with non-anticancer drugs from WHO pharmacovigilance database VigiBase®. We performed two analyses from this extraction: a global analysis and an analysis focusing on vaccination-related issues. We extracted 120 cases corresponding to 269 drugs, of which 130 were non-anticancer (22 vaccines). Among the non-anticancer drugs, tozinameran was the most reported treatment (4.46% of cases), followed by levofloxacin (2.97%) and folinic acid (2.60%), dexamethasone (2.23), and ChAdOx1 nCoV-19 vaccine and prednisone (1.86% each). Among vaccines, tozinameran (54.55% of cases) was the most reported, followed by ChAdOx1 nCoV-19 (22.73%), HPV and inactivated influenza vaccine (9.09% each), and elasomeran (4.55%). Our study first describes the occurrence of radiation recall reactions during non-anticancer treatment. It also highlights a potential safety signal with COVID-19 vaccines.
MeSH term(s)	Humans ; COVID-19 Vaccines ; ChAdOx1 nCoV-19 ; COVID-19/epidemiology ; COVID-19/prevention & control ; BNT162 Vaccine ; Radiodermatitis ; Influenza Vaccines
Chemical Substances	COVID-19 Vaccines ; ChAdOx1 nCoV-19 (B5S3K2V0G8) ; BNT162 Vaccine ; Influenza Vaccines
Language	English
Publishing date	2023-01-11
Publishing country	England
Document type	Journal Article
ZDB-ID	639134-5
ISSN	1472-8206 ; 0767-3981
ISSN (online)	1472-8206
ISSN	0767-3981
DOI	10.1111/fcp.12866
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Article ; Online: Psoriasis risk after beta-blocker exposure: Description of a pharmacovigilance signal.

Azzouz, Brahim / De Guizelin, Apolline / Lambert, Aude / Fresse, Audrey / Morel, Aurore / Trenque, Thierry

British journal of clinical pharmacology

2022 Volume 88, Issue 8, Page(s) 3813–3818

Abstract: Aim: We aimed to investigate French pharmacovigilance data. The objective was to characterize psoriatic conditions that occurred after beta-blocker (BB) exposure and bring to light a possible pharmacovigilance signal.: Methods: Spontaneous reports of ...

Abstract	Aim: We aimed to investigate French pharmacovigilance data. The objective was to characterize psoriatic conditions that occurred after beta-blocker (BB) exposure and bring to light a possible pharmacovigilance signal. Methods: Spontaneous reports of psoriatic conditions recorded in the French National Pharmacovigilance Database (FPVD) between 1985 and 2019 were extracted. We performed a retrospective, descriptive analysis of reports linked to BB exposure. Association between psoriasis risk and BB exposure was assessed using a case/noncase study. Results: Two hundred and twenty-five reports of psoriatic conditions after BB exposure were recorded in the FPVD during the study period. Both cardioselective and noncardioselective, topical and systemic BBs are involved. Therapeutic indication of BB was mainly hypertension. Mean time to onset was 5 months and outcome was favourable in 68% after BB discontinuation. These features were concordant with those of literature reports. The reporting odds ratio (ROR) was 8.95 (95% confidence interval 7.75-10.33). Conclusion: We highlighted a statistically significant disproportionality which constitutes a pharmacovigilance signal. Psoriasis risk with BBs is a class effect. Increasing surveillance during the first year of BB exposure is needed.
MeSH term(s)	Adrenergic beta-Antagonists/adverse effects ; Adverse Drug Reaction Reporting Systems ; Databases, Factual ; Humans ; Pharmacovigilance ; Psoriasis/chemically induced ; Psoriasis/drug therapy ; Psoriasis/epidemiology ; Retrospective Studies
Chemical Substances	Adrenergic beta-Antagonists
Language	English
Publishing date	2022-04-06
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15330
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Radiological evolution of progestogen-induced meningioma: A monocentric retrospective study.

Ahmed-Khalifa, Taghla / Gillet, Romain / Blonski, Marie / Rech, Fabien / Fresse, Audrey / Gillet, Pierre / Taillandier, Luc / Petitpain, Nadine

Fundamental & clinical pharmacology

2023 Volume 37, Issue 4, Page(s) 868–878

Abstract: Cyproterone acetate (CPA) is known to induce meningioma, and recently, nomegestrol acetate (NMA) and chlormadinone acetate (CMA) were also involved. Progestagen-induced meningioma management starts with progestogen discontinuation and is either ... ...

Abstract	Cyproterone acetate (CPA) is known to induce meningioma, and recently, nomegestrol acetate (NMA) and chlormadinone acetate (CMA) were also involved. Progestagen-induced meningioma management starts with progestogen discontinuation and is either interventional (surgery and/or radiotherapy) or conservative (clinical and MRI radiological follow-up). We performed a retrospective volumetric radiological outcomSe study of progestogen-induced meningiomas diagnosed in our hospital. We analysed progestogen-related meningiomas diagnosed until 30 June 2021, with at least one diagnostic and one follow-up MRI results. Meningioma volumes were centrally retrospectively measured using a T1-weighted 3D millimeter sequence with gadolinium injection on a postprocessing console. We analysed 98 meningiomas of 38 females and one transgender (male-to-female), of which 25 (64.1%) had taken CPA, seven (17.9%) NMA, three (7.7%) CMA, and four (10.2%) several progestogens. Eleven patients (24 meningiomas) underwent interventional management, seven patients had meningiomas followed by conservative or interventional management, and 21 patients (51 meningiomas) had only conservative management. Of these 21 patients, 17 had discontinued their progestogen less than 6 months before, of which 14 (82.3%) had decreased or stable meningioma(s) during a 24-month median follow-up (3 to 75) period. Overall, four of the 39 patients experienced meningioma progression (three during conservative treatment and one after surgery), including two patients who had continued NMA or CMA treatment several years after diagnosis. Our study confirms a generally favourable outcome of progestogen-related meningioma after conservative treatment, especially for CPA. It also underlines the need for progestogen discontinuation at meningioma diagnosis.
MeSH term(s)	Humans ; Male ; Female ; Meningioma/chemically induced ; Meningioma/diagnostic imaging ; Meningioma/surgery ; Progestins/adverse effects ; Retrospective Studies ; Meningeal Neoplasms/chemically induced ; Meningeal Neoplasms/diagnostic imaging ; Meningeal Neoplasms/surgery ; Magnetic Resonance Imaging
Chemical Substances	Progestins
Language	English
Publishing date	2023-02-03
Publishing country	England
Document type	Journal Article
ZDB-ID	639134-5
ISSN	1472-8206 ; 0767-3981
ISSN (online)	1472-8206
ISSN	0767-3981
DOI	10.1111/fcp.12878
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Article ; Online: COVID-19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study.

Prontskus, Viktoryia / Fresse, Audrey / Yelehe-Okouma, Mélissa / Facile, Anthony / Pietri, Tessa / Simon, Corinne / Le Souder, Cosette / Beurrier, Mathilde / Gillet, Pierre

Clinical pharmacology and therapeutics

2023 Volume 113, Issue 5, Page(s) 1107–1116

Abstract: COVID-19 vaccination is critical in frequently immunocompromised patients with rheumatoid arthritis (RA). However, there is a question about the risk of RA flares following vaccination. Our study intended to find out about cases of new RA or flare-ups in ...

Abstract	COVID-19 vaccination is critical in frequently immunocompromised patients with rheumatoid arthritis (RA). However, there is a question about the risk of RA flares following vaccination. Our study intended to find out about cases of new RA or flare-ups in people who already had RA that were reported in French and international pharmacovigilance databases after COVID-19 vaccination. We performed a "case-noncase" method in the international pharmacovigilance database VigiBase to identify the risk of RA following COVID-19 vaccination compared with other nonlive vaccines. Using the French Pharmacovigilance Database (FPVD), a descriptive analysis was carried out for RA cases after COVID-19 immunization and a multivariate logistic regression analysis was conducted to compare variables in the new-onset vs. flare-up groups. In 2021, 2,387 cases of RA were reported from 2,817,902 adverse drug reactions associated with COVID-19 vaccines recorded in VigiBase. The reporting odds ratio of RA onset with COVID-19 vaccines compared with the other nonlive vaccines was 0.66 (P < 0.0001). The FPVD reported 161 cases of RA with COVID-19 vaccines, including 77 new-onset RA and 84 cases of RA flare-up. In 88 cases (84.7%), RA occurred after the first dose. The mean time between vaccination and disease onset was 14 ± 21 days, and the delay was significantly shorter in the flare-up group. We do not show a higher risk of RA after COVID-19 vaccination compared with other nonlive vaccines in adults. De novo RA was more likely to happen quickly, be more severe, and have a worse outcome than flares in patients with RA.
MeSH term(s)	Adult ; Humans ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/epidemiology ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; Incidence ; Vaccination/adverse effects ; Vaccines
Chemical Substances	COVID-19 Vaccines ; Vaccines
Language	English
Publishing date	2023-02-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.2866
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Article ; Online: Zoledronate and osteonecrosis of the jaw in osteoporosis: incidence and risk factors. Analysis of the French Pharmacovigilance Database.

Amigues, Claire / Fresse, Audrey / Roux, Christian Hubert / Gauthier, Sophie / Vieillard, Marie-Hélène / Drici, Milou-Daniel / Breuil, Véronique

Joint bone spine

2023 Volume 90, Issue 6, Page(s) 105599

Abstract: Introduction: Bisphosphonate-related osteonecrosis of the jaw (BRONJ) have been characterized with the use of oral bisphosphonates in osteoporosis and zoledronate in oncology. Uncertainties remain, though, with the occurrence of BRONJ related to the use ...

Abstract	Introduction: Bisphosphonate-related osteonecrosis of the jaw (BRONJ) have been characterized with the use of oral bisphosphonates in osteoporosis and zoledronate in oncology. Uncertainties remain, though, with the occurrence of BRONJ related to the use of zoledronate in osteoporosis. Objectives: We aimed to estimate the incidence and characterize the risk factors of zoledronate-associated BRONJ in osteoporosis as compared with oral bisphosphonates in real life setting. Methods: Cases of BRONJ associated with zoledronate, alendronate or risedronate were extracted from the French pharmacovigilance database up to 2020. The incidence of BRONJ was estimated as their respective numbers related to cases of BRONJ in patients treated with bisphosphonates for osteoporosis, over the same period, according to the Medic'AM database. Results: Between 2011 and 2020, BRONJ incidence with zoledronate was 9.6/100,000 patient-year (PY), significantly higher than with alendronate (5.1/100,000 PY, P<0.001), and risedronate (2.0/100,000 PY, P<0.001). The number of patients treated with bisphosphonates has steadily decreased by 44.5% over 10 years. Meanwhile, the incidence of BRONJ decreased (5.8/100,000 PY in 2011; 1.5/100,000 in 2020), although a rebound was observed in 2018, including 47.6% of BRONJ following denosumab. Apart from classical risk factors, recent dental cares stood out in more than 40% of BRONJ, and zoledronate had a shorter exposure time than oral bisphosphonates. Conclusions: In a real-life setting, our data confirm that zoledronate-associated BRONJ in osteoporosis is scarce, seeming slightly more common compared with oral bisphosphonates. We also raise awareness of dental care guidelines and greater vigilance when using bisphosphonates in patients with previous exposure to denosumab.
MeSH term(s)	Humans ; Zoledronic Acid/adverse effects ; Alendronate/adverse effects ; Bone Density Conservation Agents/adverse effects ; Risedronic Acid ; Denosumab ; Pharmacovigilance ; Incidence ; Diphosphonates/adverse effects ; Osteoporosis/drug therapy ; Osteoporosis/epidemiology ; Osteoporosis/chemically induced ; Bisphosphonate-Associated Osteonecrosis of the Jaw/diagnosis ; Bisphosphonate-Associated Osteonecrosis of the Jaw/epidemiology ; Bisphosphonate-Associated Osteonecrosis of the Jaw/etiology ; Risk Factors
Chemical Substances	Zoledronic Acid (6XC1PAD3KF) ; Alendronate (X1J18R4W8P) ; Bone Density Conservation Agents ; Risedronic Acid (KM2Z91756Z) ; Denosumab (4EQZ6YO2HI) ; Diphosphonates
Language	English
Publishing date	2023-06-02
Publishing country	France
Document type	Journal Article
ZDB-ID	2020487-5
ISSN	1778-7254 ; 1297-319X
ISSN (online)	1778-7254
ISSN	1297-319X
DOI	10.1016/j.jbspin.2023.105599
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Article ; Online: Cross-reactivity among and between macrolides, lincosamides, and streptogramins: Study on the French pharmacovigilance database.

Le Baron, Quentin / Bourneau-Martin, Delphine / Babin, Marina / Gouraud, Aurore / Tauber, Marie / Fresse, Audrey / Lebrun-Vignes, Bénédicte / Delaunay, Juliette / Morisset, Martine / Briet, Marie

Fundamental & clinical pharmacology

2024

Abstract: Background: Hypersensitivity reactions (HSR) are reported for the macrolides, lincosamides, and streptogramins (MLS) antibiotic family. Data about cross-reactivity among and between MLS remain scarce or controversial.: Objectives: The aim of this ... ...

Abstract	Background: Hypersensitivity reactions (HSR) are reported for the macrolides, lincosamides, and streptogramins (MLS) antibiotic family. Data about cross-reactivity among and between MLS remain scarce or controversial. Objectives: The aim of this study was to provide an overview of hypersensitivity cross-reactions among MLSs based on data extracted from the French National Pharmacovigilance Database (FPVD). Methods: Cases of HSR to MLSs reported between January 1985 and December 2019 were extracted from the FPVD using standardized MedDRA queries (SMQ). Cases including an allergological test involving multiple MLSs and giving at least one positive result were included. Results: Of the 8394 cases reviewed, 149 were included. HSR mainly involved pristinamycin (n = 83; 53.2%) and spiramycin (n = 31; 19.9%). HSR to MLS was immediate in 54 cases and delayed in 94 cases. Skin tests represented the majority of the allergological tests performed (n = 728; 84.7%), followed by reintroduction tests (n = 79; 9.2%). Eighty-six cross-reactivities among MLS were identified in 62 cases (41.6%). All the 25 explorations performed for streptogramins showed cross-reactivities, but only 30/253 among macrolides (11.9%). Cross-reactivities between the three MLS were observed in 31/322 (9.6%) of the allergological explorations. Conclusion: This study highlights the possibility of cross-reactivity among and between MLSs. Dermatologists and allergologists managing patients with HSR to MLSs should be aware of a risk of cross-reactivity among the macrolides and between the different classes of MLS and to perform MLSs allergological testing before recommending an alternative antibiotic, especially in severe drug hypersensitivity from the MLS family.
Language	English
Publishing date	2024-04-08
Publishing country	England
Document type	Journal Article
ZDB-ID	639134-5
ISSN	1472-8206 ; 0767-3981
ISSN (online)	1472-8206
ISSN	0767-3981
DOI	10.1111/fcp.13005
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Article ; Online: Adverse drug reactions of hydroxychloroquine: Analysis of French pre-pandemic SARS-CoV2 pharmacovigilance data.

Grandvuillemin, Aurélie / Fresse, Audrey / Cholle, Clément / Yamani, Samir / Dautriche, Anne

Therapie

2020 Volume 75, Issue 4, Page(s) 385–387

MeSH term(s)	Adverse Drug Reaction Reporting Systems ; COVID-19/drug therapy ; Drug-Related Side Effects and Adverse Reactions ; France/epidemiology ; Humans ; Hydroxychloroquine/adverse effects ; Pandemics ; Pharmacovigilance ; RNA, Viral ; SARS-CoV-2
Chemical Substances	RNA, Viral ; Hydroxychloroquine (4QWG6N8QKH)
Keywords	covid19
Language	English
Publishing date	2020-05-05
Publishing country	France
Document type	Letter
ZDB-ID	603474-3
ISSN	1958-5578 ; 0040-5957
ISSN (online)	1958-5578
ISSN	0040-5957
DOI	10.1016/j.therap.2020.05.001
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