Pharmacovigilance – The next chapter

Moore, Nicholas; Berdaï, Driss; Blin, Patrick; Droz, Cécile

doi:10.1016/j.therap.2019.09.004

Cited by 141 publications

(61 citation statements)

References 87 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The French pharmacovigilance database (FPVD) [18] centralizes all spontaneous reports of ADR [19], respecting anonymity of both patients and notifiers, in order to accrue the European database EudraVigilance. Such reporting of ADR is deemed mandatory in France for every health professional.…”

Section: Methodsmentioning

confidence: 99%

“Off-label” use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers

et al. 2020

View full text Add to dashboard Cite

Introduction.-COVID-19 is an unprecedented challenge for physicians and scientists. Several publicized drugs are being used with not much evidence of their efficacy such as hydroxychloroquine, azithromycin or lopinavir-ritonavir. Yet, the cardiac safety of these drugs in COVID-19 deserves scrutiny as they are known to foster cardiac adverse ADRs, notably QTc interval prolongation on the electrocardiogram and its arrhythmogenic consequences. Methods.-Since March 27th, 2020, the French Pharmacovigilance Network directed all cardiac adverse drug reactions associated with ''off-label'' use of hydroxychloroquine, azithromycin and lopinavir-ritonavir in COVID-19 to the Nice Regional Center of Pharmacovigilance. Each Regional Center of Pharmacovigilance first assessed causality of drugs. We performed a specific analysis of these cardiac adverse drug reactions amidst an array of risk factors, reassessed the electrocardiograms and estimated their incidence in coronavirus disease 2019.

show abstract

Section: Methodsmentioning

confidence: 99%

“Off-label” use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers

et al. 2020

View full text Add to dashboard Cite

show abstract

“…They are reflective of clinical conditions and cases were retrieved from the world's largest pharmacovigilance database. It used a validated method for the first detection of pharmacovigilance signals [7][8][9]. We found high significant values of ROR suggesting a true association between the investigated factors.…”

Section: Discussionmentioning

confidence: 87%

“…We excluded ICSRs from patients with sex unknown as well as those < 18 years and > 64 years because in a preliminary analysis of VigiBase ® we failed to find any fatal outcome with the drug association (hydroxychloroquine + metformin) in patients aged < 18 and > 64 years. Following current protocols to detect a pharmacovigilance signal in large pharmacovigilance databases [8], we performed a disproportionality analysis (case/non-case analysis) [8], with cases being occurrence of 'fatal outcomes' with hydroxychloroquine (or chloroquine) (P01BA according to ATC classification of drugs) and non-cases all other ICSRs with hydroxychloroquine (or chloroquine) alone. Data with hydroxychloroquine (or chloroquine) alone were compared with the association hydroxychloroquine (or chloroquine) + metformin (A10BA).…”

Section: Methodsmentioning

confidence: 99%

A New Drug–Drug Interaction Between Hydroxychloroquine and Metformin? A Signal Detection Study

Montastruc

Toutain

2020

Drug Saf

View full text Add to dashboard Cite

Introduction Hydroxychloroquine was recently promoted in patients infected with COVID-19 infection. A recent experimental study has suggested an increased toxicity of hydroxychloroquine in association with metformin in mice. Objective The present study was undertaken to investigate the reality of this putative drug-drug interaction between hydroxychloroquine and metformin using pharmacovigilance data. Methods Using VigiBase ® , the WHO pharmacovigilance database, we performed a disproportionality analysis (case/noncase study). Cases were reports of fatal outcomes with the drugs of interest and non-cases were all other reports for these drugs registered between 1 January 2000 and 31 December 2019. Data with hydroxychloroquine (or metformin) alone were compared with the association hydroxychloroquine + metformin. Results are reported as ROR (reporting odds ratio) with their 95% confidence interval. Results Of the 10,771 Individual Case Safety Reports (ICSR) involving hydroxychloroquine, 52 were recorded as 'fatal outcomes'. In comparison with hydroxychloroquine alone, hydroxychloroquine + metformin was associated with an ROR value of 57.7 (23.9-139.3). In comparison with metformin alone, hydroxychloroquine + metformin was associated with an ROR value of 6.0 (2.6-13.8). Conclusion Our study identified a signal for the association hydroxychloroquine + metformin that appears to be more at risk of fatal outcomes (particularly by completed suicides) than one of the two drugs when given alone.

show abstract

“…Data are those from the real world, not studies in clinical trials. Second, our analysis used a validated method (disproportionality between reports) which was previously found able to detect rare safety signals 10–12 . In fact, several papers have shown consistent results for drug risk evaluation between prescription databases and VigiBase®.…”

Section: Discussionmentioning

confidence: 98%

“…For example, a recent Canadian paper found similar risk values between CPRD and VigiBase ® for cholangiocarcinoma with incretinbased drugs in type 2 diabetic patients. 22 In contrast, the work has some mandatory limitations inherent to the method used and like every analysis performed in a pharmacovigilance database [10][11][12] : lack of systematic recording of drug exposure duration or drug doses, reporting bias with either underreporting or selective reporting. Moreover, we did not take into account all the underlying diseases which could be associated or risk factors for the development of hyponatraemia, since these data are not systematically recorded in Vigibase ® .…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Can tramadol really induce hyponatraemia? A pharmacovigilance study

Canecaude

Rousseau

Chebane

et al. 2020

Brit J Clinical Pharma

View full text Add to dashboard Cite

Several papers have described hyponatraemia with tramadol. However, in most reports, several confounding factors can be found. We used the WHO pharmacovigilance database (VigiBase®) to investigate if tramadol alone could be associated with hyponatraemia. All 1992–2019 ICSRs (individual case safety reports) with the preferred term (PT) “hyponatraemia” and tramadol were included. Two disproportionality analyses were performed: (1) after inclusion of all reports, and (2) after exclusion of concomitant hyponatraemic drugs. Results are expressed as reporting odds ratios (ROR; 95% CI) and information component (IC). Of 19 747 604 ICSRs, 225 575 were included. A significant association was found between tramadol use and reports of hyponatraemia (ROR = 1.49 [1.39–1.60], IC = 0.57 [IC025 = 0.47]). After exclusion of hyponatraemic drugs, the previously found association disappeared. The study failed to find any pharmacovigilance signal of hyponatraemia with tramadol alone. We suggest that reports of hyponatraemia with tramadol can be explained principally by other underlying causes of hyponatraemia, especially other concomitant hyponatraemic drugs.

show abstract

Pharmacovigilance – The next chapter

Cited by 141 publications

References 87 publications

“Off-label” use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers

“Off-label” use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers

A New Drug–Drug Interaction Between Hydroxychloroquine and Metformin? A Signal Detection Study

Can tramadol really induce hyponatraemia? A pharmacovigilance study

Contact Info

Product

Resources

About