Desogestrel and severe psychiatric disorders, a retrospective analysis of Federal Adverse Event Reporting System and Eudravigilance

2020 ◽  
Vol 15 ◽  
Author(s):  
Manan Shah ◽  
Charmy Kothari
Keyword(s):  
Psychiatric Disorders ◽  
Suicide Attempts ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Severe Depression ◽  
Panic Attacks ◽  
Drug Event ◽  
Event Pair ◽  
Information Leaflets ◽  
Risk Association

Background: Several studies have been published which stated that there is some connection between severe psychiatric disorders and contraceptive drug “desogestrel”. However, nothing in the summary of product characteristics (SmPC) or patient information leaflets of desogestrel about anxiety, more severe anxiety leading to panic attacks, or about risks of severe depression leading to suicidal thoughts or suicide attempts. Objective: To examine the safety and risk association between hormonal contraceptive desogestrel among women with psychiatric disorders using adverse drug reaction database of FDA Adverse Events Reporting System (FAERS) and Eudravigilance (EV). Methods: Individual case safety reports (ICSRs) of only female patients from Jan 1999 to Nov 2019 and Jan 2004 to Nov 2019 were downloaded from FAERS and EV database respectively. Reports of drug desogestrel, dienogest, norgestimate, cyproterone acetate and drospirenone were downloaded. Disproportionality method of data mining was used to calculate the risk association. Results and Discusion: The lower limit of 95 % CI of PRR is -0.28 and 2.02, PRR was 1.08 and 9.18, ROR is 1.09 (95%CI: 0.74, 1.59) and 9.26 (95% CI: 7.21, 11.89), Chi square value is 1.21 and 433.68, and IC-2SD is -0.27 and 2.60 respectively for data obtained from FAERS and EV. Conclusion: From this study, we conclude that there is no new emerging signal for the drug-event pair studied. Further study and continuous monitoring is required in future to know more about this drug-event pair association, as severe psychiatric disorders is not yet mentioned or included in SmPC and patient leaflet of desogestrel.

scholarly journals 1977. Comparing Acute Kidney Injury Risk among Antibiotic Classes: A Study of the FDA Adverse Event Reporting System (FAERS)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S662-S662
Author(s):  
Taylor M Patek ◽  
Chengwen Teng ◽  
Kaitlin E Kennedy ◽  
Christopher R Frei
Keyword(s):  
Acute Kidney Injury ◽  
Adverse Event ◽  
Injury Risk ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Kidney Injury ◽  
Adverse Event Reporting ◽  
Drug Event ◽  
Event Reporting ◽  
Increased Risk

Abstract Background A recent article published in 2018 studied the FDA Adverse Event Reporting System (FAERS) and listed the most common medications associated with acute kidney injury (AKI) based on number of AKI reports. In regards to antibiotics, the study only ranked vancomycin, fluoroquinolones, penicillin combinations, and trimethoprim–sulfamethoxazole as having a significant association with AKI. The objective of this study was to evaluate those and additional antibiotic classes using FAERS, and to compare their risk associated with this adverse drug event. Methods FAERS reports from January 1, 2015 to December 31, 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify AKI cases. Reporting Odds Ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and AKI were calculated. An association was considered statistically significant when the lower limit of the 95% CI was greater than 1.0. Results A total of 2,042,801 reports (including 20,138 acute kidney injury reports) were considered, after inclusion criteria were applied. Colistin had the greatest proportion of AKI reports, representing 25% of all colistin reports. Acute kidney injury RORs (95% CI) for antibiotics were (in descending order): colistin 33.10 (21.24–51.56), aminoglycosides 17.41 (14.49–20.90), vancomycin 15.28 (13.82–16.90), trimethoprim-sulfamethoxazole 13.72 (11.94–15.76), penicillin combinations 7.95 (7.09–8.91), clindamycin 6.46 (5.18–8.04), cephalosporins 6.07 (5.23–7.05), daptomycin 6.07 (4.61–7.99), macrolides 3.60 (3.04–4.26), linezolid 3.48 (2.54–4.77), carbapenems 3.31 (2.58–4.25), metronidazole 2.55 (1.94–3.36), tetracyclines 1.73 (1.26–2.36), and fluoroquinolones 1.71 (1.49–1.97). Conclusion This study found 17 classes of antibiotics and combinations that were significantly associated with AKI compared with four antibiotics that were mentioned in a recently published article looking at drug-associated AKI. While this study confirmed previous literature of certain antibiotics associated with increased risk of AKI, it also compared antibiotics within classes and provided additional insight regarding which antibiotics had the highest associated risk of an AKI. Disclosures All authors: No reported disclosures.

Adverse Drug Events in the Prevention and Treatment of COVID-19: A Data Mining Study on FDA Adverse Event Reporting System (FAERS) (Preprint)

2021 ◽  
Author(s):  
Qiang Guo ◽  
Shaojun Duan ◽  
Yaxi Liu ◽  
Yinxia Yuan
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Adverse Drug Events ◽  
Reporting System ◽  
Proportional Reporting Ratio ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Event ◽  
Event Reporting ◽  
Prevention And Treatment

BACKGROUND In the emergency situation of COVID-19, off-label therapies and newly developed vaccines may bring the patients adverse drug event (ADE) risks. Data mining based on spontaneous reporting systems (SRSs) is a promising and efficient way to detect potential ADEs so as to help health professionals and patients get rid of these risks. OBJECTIVE This pharmacovigilance study aimed to investigate the ADEs of “Hot Drugs” in COVID-19 prevention and treatment based on the data of the US Food and Drug Administration (FDA) adverse event reporting system (FAERS). METHODS FAERS ADE reports associated with COVID-19 from the 2nd quarter of 2020 to the 2nd quarter of 2021 were retrieved with “Hot Drugs” and frequent ADEs recognized. A combination of support, proportional reporting ratio (PRR) and Chi-square (2) test was applied to detect significant “Hot Drug” & ADE signals by Python programming language on Jupyter notebook. RESULTS 13,178 COVID-19 cases were retrieved with 18 “Hot Drugs” and 312 frequent ADEs on “Preferred Term” (PT) level. 18  312 = 5,616 “Drug & ADE” candidates were formed for further data mining. The algorithm finally produced 219 significant ADE signals associated with 17 “Hot Drugs”and 124 ADEs.Some unexpected ADE signals were observed for chloroquine, ritonavir, tocilizumab, Oxford/AstraZeneca COVID-19 Vaccine and Moderna COVID-19 Vaccine. CONCLUSIONS Data mining is a promising and efficient way to assist pharmacovigilance work and the result of this paper could help timely recognize ADEs in the prevention and treatment of COVID-19.

scholarly journals Analysis of anticholinergic adverse effects using two large databases: The US Food and Drug Administration Adverse Event Reporting System database and the Japanese Adverse Drug Event Report database

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0260980
Author(s):  
Junko Nagai ◽  
Yoichi Ishikawa
Keyword(s):  
Adverse Event ◽  
Adverse Drug Event ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Event ◽  
Beers Criteria ◽  
Event Report ◽  
Event Reporting ◽  
The Us

Introduction Anticholinergic adverse effects (AEs) are a problem for elderly people. This study aimed to answer the following questions. First, is an analysis of anticholinergic AEs using spontaneous adverse drug event databases possible? Second, what is the main drug suspected of inducing anticholinergic AEs in the databases? Third, do database differences yield different results? Methods We used two databases: the US Food and Drug Administration Adverse Event Reporting System database (FAERS) and the Japanese Adverse Drug Event Report database (JADER) recorded from 2004 to 2020. We defined three types of anticholinergic AEs: central nervous system (CNS) AEs, peripheral nervous system (PNS) AEs, and a combination of these AEs. We counted the number of cases and evaluated the ratio of drug–anticholinergic AE pairs between FAERS and JADER. We computed reporting odds ratios (RORs) and assessed the drugs using Beers Criteria®. Results Constipation was the most reported AE in FAERS. The ratio of drug–anticholinergic AE pairs was statistically significantly larger in FAERS than JADER. Overactive bladder agents were suspected drugs common to both databases. Other drugs differed between the two databases. CNS AEs were associated with antidementia drugs in FAERS and opioids in JADER. In the assessment using Beers Criteria®, signals were detected for almost all drugs. Between the two databases, a significantly higher positive correlation was observed for PNS AEs (correlation coefficient 0.85, P = 0.0001). The ROR was significantly greater in JADER. Conclusions There are many methods to investigate AEs. This study shows that the analysis of anticholinergic AEs using spontaneous adverse drug event databases is possible. From this analysis, various suspected drugs were detected. In particular, FAERS had many cases. The differences in the results between the two databases may reflect differences in the reporting countries. Further study of the relationship between drugs and CNS AEs should be conducted.

Fatal neutropenic enterocolitis associated with docetaxel use: A review of cases reported to the United States Food and Drug Administration Adverse Event Reporting System

2019 ◽  
Vol 26 (4) ◽  
pp. 923-928 ◽  
Author(s):  
Pritpal Singh ◽  
Afrouz Nayernama ◽  
S Christopher Jones ◽  
Laleh Amiri Kordestani ◽  
Katherine Fedenko ◽  
...  
Keyword(s):  
Adverse Event ◽  
Median Time ◽  
Drug Administration ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Event ◽  
Neutropenic Enterocolitis ◽  
Event Reporting

Docetaxel is a microtubule inhibitor indicated for the treatment of multiple cancers as a single agent or in combination with other antineoplastics. The U.S. Food and Drug Administration (FDA) conducted a postmarketing review of fatal neutropenic enterocolitis cases reported with docetaxel using the FDA Adverse Event Reporting System (FAERS) and literature to determine whether the drug was a potential cause. We searched FAERS and the literature for reports of fatal neutropenic enterocolitis with docetaxel-based treatment reported between 14 May 1996 and 13 March 2017. We characterized the clinical course and severity of neutropenic enterocolitis and utilized the World Health Organization-Uppsala Monitoring Centre rubric to assess drug causality. We identified 41 fatal cases of neutropenic enterocolitis with docetaxel from FAERS and the literature. The median time to onset of neutropenic enterocolitis from last docetaxel dose was seven days (range 2–13 days), and median time to death was nine days (range 3–23 days). The cause of death in 83% (34/41) of patients was neutropenic enterocolitis. We determined the drug-event association as probable in seven cases. Neutropenic enterocolitis with docetaxel monotherapy occurred in six cases; however, in 85% (35/41) of cases, neutropenic enterocolitis occurred when docetaxel was used in combination with other cytotoxic chemotherapy. In some cases, neutropenic enterocolitis occurred despite use of granulocyte colony-stimulating factors. Neutropenic enterocolitis is a severe and potentially fatal complication of docetaxel-based treatment, especially when combined with other antineoplastic treatments known to cause neutropenia. Practitioners should be aware of this safety risk to promptly recognize and manage patients.

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