Gender Differences In Adverse Events Research Articles

Signal mining and gender differences analysis of adverse events in NMIBC treatment with gemcitabine and BCG bladder instillation based on the FAERS database

ABSTRACT Objective To explore safety differences and perform a gender-based analysis of adverse events related to gemcitabine and Bacillus Calmette-Guérin (BCG) vaccine using the U.S. FDA Adverse Event Reporting System (FAERS) database. Methods Using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods, adverse events associated with gemcitabine and BCG were mined from FAERS database reports spanning from Q1 2004 to Q3 2023. Results The study extracted 37,855 reports with gemcitabine and 5,455 reports with BCG as the primary suspected drugs. Adverse events were more prevalent in males (male-to-female ratio: gemcitabine 1.10, BCG 4.25). Differences in high-frequency adverse events among the top 20 signals were detected for both drugs. Both drugs affected similar organ systems, including potential pulmonary, ocular, and renal toxicity, with gemcitabine showing a broader range of adverse events. Gender analysis revealed fewer adverse reactions to gemcitabine in females, while males had fewer adverse reactions to BCG. Conclusion Differences in high-frequency adverse events between gemcitabine and BCG, including some not listed on drug labels, were observed. Both drugs affect similar organ systems, with gemcitabine showing a broader range of adverse events. Gender differences in adverse events were notable.

Sex and gender differences in adverse events following influenza and COVID-19 vaccination

IntroductionActive and passive surveillance studies have found that a greater proportion of females report adverse events (AE) following receipt of either the COVID-19 or seasonal influenza vaccine compared to males. In a predominately young adult female population of healthcare workers, we sought to determine the intersection of biological sex and sociocultural gender differences in prospective active reporting of vaccine outcomes, which remains poorly characterized.MethodsThis cohort study enrolled Johns Hopkins Health System healthcare workers (HCWs) who were recruited from the mandatory annual fall 2019–2022 influenza vaccine and the fall 2022 COVID-19 bivalent vaccine campaigns. Vaccine recipients were enrolled the day of vaccination and AE surveys were administered two days post-vaccination for bivalent COVID-19 and influenza vaccine recipients. Data were collected regarding the presence of a series of solicited local and systemic AEs. Open-ended answers about participants’ experiences with AEs also were collected for the COVID-19 vaccine recipients.ResultsFemales were more likely to report local AEs after either influenza (OR = 2.28, p = 0.001) or COVID-19 (OR = 2.57, p = 0.008) vaccination compared to males, regardless of age or race. Males and females had comparable probabilities of reporting systemic AEs after either influenza (OR = 1.18, p = 0.552) or COVID-19 (OR = 0.96, p = 0.907) vaccination. Hormonal birth control use did not impact the rates of reported AEs following influenza vaccination among reproductive-aged female HCWs. Women reported more interruptions in their daily routine following COVID-19 vaccination than men and were more likely to seek out self-treatment. More women than men scheduled their COVID-19 vaccination before their days off in anticipation of AEs.ConclusionsOur findings highlight the need for sex- and gender-inclusive policies to inform more effective mandatory occupational health vaccination strategies. Further research is needed to evaluate the potential disruption of AEs on occupational responsibilities following mandated vaccination for healthcare workers, a predominately female population, and to more fully characterize the post-vaccination behavioral differences between men and women.

Gender Differences in Adverse Events of Ketamine Drugs: A Real-World Study Based on FAERS

Objective. To identify gender differences in the adverse events (AEs) of ketamine, reduce the AEs among patients, and contribute to the advancement of personalized medicine. Methods. A normalized dataset from 2004 Q1 to the 2022 Q4 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) was analysed. The reporting odds ratio (ROR), proportional reporting ratio (PRR), and P value were used to detect the risk signals from the data in the FAERS database and quantify the presence and extent of gender differences in ketamine AEs. Results. Totally, 5,477 ketamine (female/male (2507/1795)) AE reports were analysed, and sedation (ROR 1.30 (1.07, 1.58)), suicidal ideation (ROR 1.30 (1.03, 1.64)), nausea (ROR 1.37 (1.05, 1.78)), depression (ROR 1.22 (1.13, 1.61)), dizziness (ROR 2.25 (1.78, 2.90)), anxiety (ROR 1.48 (1.09, 1.99)), and other adverse events were found to be significantly more frequent in male patients than in female patients. Conclusion. Using FAERS, we identified gender as factors associated with ketamine-related AEs. With the limitations inherent to this open data source, our data need prospective validation but elucidate potential factors for a personalized side effect profiling.

Gender differences in spontaneous adverse event reports associated with zolpidem in South Korea, 2015-2019.

Study objectives: While zolpidem is considered as an example of a gender effect on drug response, there is insufficient evidence to reach a consensus. This study aimed to investigate gender differences in adverse events (AEs) of zolpidem. Methods: We estimated the difference between the reporting odds ratios (RORs) calculated in gender subgroups for the AEs signals detected in data mining using 2015-2019 Korea voluntary adverse drug events reporting system (KAERS) data. Different reporting risk by gender was evaluated by using the log RORs being significantly different by gender at the 5% significance level and the 95% confidence intervals of the gender ROR. Results: A total of 94 AE signals were detected. Among these, 35 signals showed significant disparities by gender at the 5% level or were detected only in one gender. When categorized by similarity of AEs, parasomnia including somnambulism and paroniria, and cardiovascular disorders including coronary thrombosis had higher reporting risks in women. Men were more likely to report cognitive disorders such as delirium, insomnia related disorders, and movement disorders. Among all AEs with gender differences in reporting risk, the difference in somnambulism was the most consistent and substantial. Conclusion: For several AEs associated with zolpidem, gender-based reporting disparities were evident. Notably, women exhibited a higher susbeptibility to somnambulism, potentially serious adverse effects of zolpidem. This underscores the need for further investigation into the underlying factors influencing these gender-specific reporting patterns.

Gender differences in adverse events related to Osimertinib: a real-world pharmacovigilance analysis of FDA adverse event reporting system

ABSTRACT Objective We analyze and identify the signals of gender differences in adverse events (ADEs) related to Osimertinib and provide reference for clinical implementation of individualized drug use. Methods ADE reports of Osimertinib received from FAERS database from the first quarter of 2016 to the fourth quarter of 2022 were extracted. Reporting odds ratio (ROR) data analysis strategy was used for mining of signal strength that represents gender differences in ADEs related to Osimertinib. Results The number of Osimertinib ADE reports included in the analysis was 7968 in females and 7570 in males, respectively. According to ROR, men were more likely to develop pneumonia aspiration, lung infection, interstitial lung disease, pulmonary toxicity, dyspnea, ventricular extrasystoles, and pulmonary thrombosis, while women were more likely to develop cardiac failure congestive, stomatitis, diarrhea, muscle spasms, nail disorder, onycholysis, skin disorder, dry skin, and rash. Conclusion Gender differences existed in ADE signals related to Osimertinib. The higher risk of ADEs in male patients was lung diseases that seem more serious than those nail toxicities or skin problems that occurred in female patients. In order to ensure the safety of medication, we should be alert to the differences between different genders and take corresponding preventive measures to reduce the occurrence of serious ADEs.

Gender Differences in Adverse Events Following the Pfizer-BioNTech COVID-19 Vaccine.

Background: The adverse events reported from the COVID-19 mRNA vaccines have varied from very mild, such as pain near the vaccination site, to more severe, with occasional anaphylaxis. Details of age-specific gender differences for the adverse effects are not well documented. Methods: Age and gender disaggregated data on reports of adverse events following two or three doses of the Pfizer-BioNTech COVID-19 vaccine were obtained from four cross-sectional studies. The first was from reports submitted to the Israel Ministry of Health national adverse events database (for ages 16 and above). The second was from a national cross-sectional survey based on an internet panel (for ages 30 and above), and the third and fourth were from cross-sectional surveys among employees of a large company (for ages 20–65) using links to a self-completed questionnaire. Results: In all studies, the risks of adverse events were higher following the second dose and consistently higher in females at all ages. The increased risk among females at all ages included local events such as pain at the injection site, systemic events such as fever, and sensory events such as paresthesia in the hands and face. For the combined adverse reactions, for the panel survey the female-to-male risk ratios (RRs) were 1.89 for the first vaccine dose and 1.82 for the second dose. In the cross-sectional workplace studies, the female-to-male RRs for the first, second and third doses exceeded 3.0 for adverse events, such as shivering, muscle pain, fatigue and headaches. Conclusions: The consistent excess in adverse events among females for the mRNA COVID-19 vaccine indicates the need to assess and report vaccine adverse events by gender. Gender differences in adverse events should be taken into account when determining dosing schedules.

Gender differences in the adverse events associated with cardiovascular drugs in a spontaneous reporting system in South Korea.

Background Studies on disease-related gender differences in pharmacodynamics and pharmacokinetics are prevalent; however, gender differences in the drug-related adverse events have not been systemically described. Objective To explore gender differences in the adverse events associated with cardiovascular drugs using a spontaneous reporting system. Setting This study was conducted using the Korea adverse event reporting system and national health insurance databases. Methods The number of reported adverse events was divided by the number of patients diagnosed with cardiovascular diseases (Korean Standard Classification of Disease, 7th Revision, I05-I70) and prescribed cardiovascular drugs. We calculated adverse event reporting rates per 100,000 persons and the reporting ratio for women, compared with men. Main outcome measures Reporting ratios across the groups of adverse events and cardiovascular drugs. Results We identified 27,533 adverse events associated with cardiovascular drugs and 9,413,666 patients with cardiovascular disease. Compared with men, reporting ratios of women were higher in the following categories: Overall (1.09, 95% CI, 1.06-1.11), beta blockers (1.20, 95% CI, 1.05-1.39), and calcium channel blockers (1.14, 95% CI, 1.03-1.27). For the adverse events, the reporting ratio was 1.34 (95% CI, 1.14-1.58) for musculoskeletal disorders and 2.54 (95% CI, 2.10-3.07) for oedema in women. Conclusion Our findings on differential adverse events reporting rates associated with the cardiovascular drugs between women and men provide an evidence on possible gender differences in wide range of pharmacotherapy. A clear understanding of the relationship between drug-induced adverse events and gender will aid in the development of therapeutic interventions being tailored to the individual patients.

Gender influences on efficacy and safety of sublingual zolpidem tartrate for middle‐of‐the‐night awakening in insomnia

Evaluate potential gender effects on efficacy and safety of a buffered zolpidem sublingual tablet (ZST) formulation. Post hoc analysis of the pivotal sleep laboratory and outpatient studies, per gender. In the sleep laboratory study, polysomnography-derived latency to persistent sleep after middle-of-the-night was significantly improved for both genders at both 1.75 mg and 3.5 mg ZST (females: 15.7 and 8.6 min, respectively, vs. 27.7 min [placebo]; males: 19.0 and 12.7 min vs. 29.0 min [placebo]) with no significant gender differences. In the outpatient study, subjective sleep onset latency after middle-of-the-night was significantly shorter for both genders treated with ZST 3.5 mg versus placebo over the 4-week average (females: 37.3 vs. 59.4 min, p < 0.0001; males: 38.6 vs. 55.1 min, p ≤ 0.01). There were no gender differences in subjective sleep onset latency after middle-of-the-night awakening. In the outpatient study, weekly usage of ZST and placebo by both genders declined throughout the study. Morning alertness following dosing nights improved in both genders, although significant only in females. In both studies, there were no gender differences in adverse events. Time to return to sleep after middle-of-the-night dosing with ZST improved in both genders, with no gender differences in efficacy and safety.