Gender differences in adverse drug reactions in dermatological patients in west Sicily: an epidemiological study

Aims We aimed to assess and characterize sex differences in adverse drug reactions (ADRs) reported to the national pharmacovigilance centre in the Netherlands while considering differences in drug use. Methods ADRs spontaneously reported by healthcare professionals and patients to the Netherlands pharmacovigilance centre Lareb were used. Drug–ADR combinations reported at least 10 times between 2003–2016 for drugs used by ≥10,000 persons in that period were included. Data about the number of drug users was obtained from the National Health Care Institute. Sex‐specific ADRs, like gynaecological problems, were excluded. Sex differences in specific drug–ADR combinations were tested using bivariate logistic regression analyses in which the number of drug users per sex was taken into account. Results In total, 2483 drug–ADR combinations were analysed. Possibly relevant sex differences were shown in 363 combinations (15%). Most of these drug–ADR combinations were reported more often for women (322 combinations). Drugs with the highest number of ADRs that were more often reported for women included thyroid hormones (32 combinations) and antidepressants (16 combinations for the centrally acting sympathomimetics; 14 combinations for other antidepressants). Some ADRs were predominantly reported for women across a range of drugs such as headache and dizziness whereas other ADRs such as tendon ruptures and aggression were reported more often for men. Conclusions Identified sex differences in reported ADRs often referred to women. These differences may have various causes, including pharmacological and behavioural causes, which need to be further assessed. The results may ultimately lead to sex‐specific prescribing or monitoring recommendations.

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“…Our study confirms findings from previous studies demonstrating that women have a higher risk for reporting ADRs than men (e.g …”

Section: Discussionsupporting

confidence: 92%

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

Vries

Denig

Ekhart

et al. 2019

Brit J Clinical Pharma

109

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“…It is unknown if hormonal factors may be involved in the female predominant adverse event profile showed in our study, but it is recognized that hormones may influence drug metabolism. Gender differences in adverse drug events have been observed before [22] [23], and factors other than hormonal effects such as body weight and differences in pharmacokinetics may be involved. In order to determine if hormonal factors are related in this pattern, it would be desirable to further study adverse event incidence in different female groups, such as before menarche and after menopause.…”

Section: Discussionmentioning

confidence: 99%

The Adverse Event Profile in Patients Treated with Transferon<sup>TM</sup> (Dialyzable Leukocyte Extracts): A Preliminary Report

Homberg¹,

Sáenz²,

Galicia-Carreón³

et al. 2015

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Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. Transferon TM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of Transferon TM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or Transferon TM. Objective: To assess the safety of Transferon TM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with * Corresponding author. Transferon TM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with Transferon TM (MD 1.9, IQR 1.7-2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with Transferon TM , and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: Transferon TM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.

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“…51 Sex hormones like estrogens and progestins have also been shown to have an important role in the occurrence of ADRs by influencing immune responses, affecting the distribution, metabolism, and hepatic and renal clearance of drugs which increase the risk of developing drugrelated toxicities. 52 This may explain the increased risk of developing chemotherapy-induced oral mucositis among female patients. Therefore, risk assessment for oral mucositis is recommended at every visit for timely management of oral mucositis among female cancer patients.…”

Section: Discussionmentioning

confidence: 99%

“…A number of sex‐related physiological differences such as differences in the pharmacokinetics and pharmacodynamics of drugs in females as compared to males, 50 lead to differences in activity of enzymes that may predispose females to an increased risk of developing ADRs 51 . Sex hormones like estrogens and progestins have also been shown to have an important role in the occurrence of ADRs by influencing immune responses, affecting the distribution, metabolism, and hepatic and renal clearance of drugs which increase the risk of developing drug‐related toxicities 52 . This may explain the increased risk of developing chemotherapy‐induced oral mucositis among female patients.…”

Section: Discussionmentioning

confidence: 99%

Prevalence and risk factors of chemotherapy‐induced oral mucositis among adult cancer patients at the cancer unit of Mbarara Regional Referral Hospital

Atwiine,

Kyomya,

Atukunda

et al. 2023

Asia-Pac J Clncl Oncology

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BackgroundChemotherapy is a common treatment for cancer, but it is associated with adverse drug reactions like oral mucositis. This condition destroys basal cells in the oral mucosal layer, causing inflammation and ulceration. This can impact the patient's physical, emotional, and psychological well‐being, affecting treatment outcomes and quality of life. This study aims to determine the prevalence, severity, and risk factors of chemotherapy‐induced oral mucositis among adult cancer patients.MethodsThe study was a cross‐sectional study conducted among adult cancer patients receiving chemotherapy at the cancer unit of Mbarara Regional Referral Hospital in southwestern Uganda. Data was collected through patient interviews, oral examinations, and patient chart reviews.ResultsOut of 268 patients, 115 (42.9%) experienced oral mucositis. Grade 2 oral mucositis was the most common (44.3%) followed by grade 1 (35.7%) and grade 3 (20.0%). Independent risk factors of chemotherapy‐induced oral mucositis were female gender (Adjusted Odds Ratio (AOR) = 2.19, 95% confidence interval [CI]: 1.27–3.78; p‐value = 0.005), poor oral hygiene (AOR = 3.70, 95% CI: 1.51–9.10; p‐value = 0.04), and receiving chemotherapy containing an alkylating agent (AOR = 3.17, 95% CI: 1.63–6.19; p‐value < 0.001).ConclusionThe study found that two out of five chemotherapy patients developed oral mucositis, with nearly half being grade 2. The risk factors identified in our study were comparable to those reported in previous studies. Therefore, identification and assessment of cancer patients at high risk for chemotherapy‐induced oral mucositis should be routinely done for proper and timely management.

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Gender differences in adverse drug reactions in dermatological patients in west Sicily: an epidemiological study

Abstract: The female gender is an important predisposing factor for the RAF: a large case series showed that in the RAF female/male ratio is 1.7:1.

Cited by 7 publications

References 4 publications

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

The Adverse Event Profile in Patients Treated with Transferon<sup>TM</sup> (Dialyzable Leukocyte Extracts): A Preliminary Report

Prevalence and risk factors of chemotherapy‐induced oral mucositis among adult cancer patients at the cancer unit of Mbarara Regional Referral Hospital

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Gender differences in adverse drug reactions in dermatological patients in west Sicily: an epidemiological study

Abstract: The female gender is an important predisposing factor for the RAF: a large case series showed that in the RAF female/male ratio is 1.7:1.

Cited by 7 publications

References 4 publications

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

The Adverse Event Profile in Patients Treated with Transferon&lt;sup&gt;TM&lt;/sup&gt; (Dialyzable Leukocyte Extracts): A Preliminary Report

Prevalence and risk factors of chemotherapy‐induced oral mucositis among adult cancer patients at the cancer unit of Mbarara Regional Referral Hospital

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The Adverse Event Profile in Patients Treated with Transferon<sup>TM</sup> (Dialyzable Leukocyte Extracts): A Preliminary Report