Therapeutic Advances in Drug Safety最新文献

{"title":"A case report of drug-induced liver injury due to the infliximab biosimilar CT-P13 on switching from original infliximab in a patient with Crohn’s disease","authors":"S. Kashima, K. Sawada, K. Moriichi, M. Fujiya","doi":"10.1177/20420986221100118","DOIUrl":"https://doi.org/10.1177/20420986221100118","url":null,"abstract":"Inflammatory bowel diseases (IBDs) are chronic immune disorders of unclear etiology. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A large number of clinical trials of infliximab biosimilar (CT-P13) have suggested that the administration of biosimilars provides high efficacy and safety similar to that of the originators, with a lower cost, so switching from the original to a biosimilar is considered an acceptable treatment. While several abnormalities of blood examination have been observed in patients with CT-P13 administration, no cases of drug-induced liver injury (DILI) caused by CT-P13 has been reported. A 23-year-old woman had been diagnosed with Crohn’s disease and was treated with original infliximab (O-IFX) for 9 years. She developed severe jaundice 1 month after switching from O-IFX to CT-P13. Serologic tests of autoimmune and hepatitis viruses were negative, and ultrasonography, computed tomography, and magnetic resonance cholangiopancreatography revealed no abnormalities. A liver biopsy showed prominent pericentral canalicular cholestasis, without features of steatosis or sclerosing cholangitis, which was consistent with drug-induced cholestasis. The cholestasis improved 10 weeks after the discontinuation of CT-P13, and no DILI redeveloped even after re-switching from CT-P13 to O-IFX. This is the first report of DILI due to switching from O-IFX to CT-P13. While the efficacy and safety of CT-P13 are considered equal to those of O-IFX, clinicians need to be alert for certain severe DILIs when switching from O-IFX to CT-P13 with careful monitoring and appropriate treatment. Plain Language Summary A case report of drug-induced liver injury due to switch from original infliximab to infliximab biosimilar Inflammatory bowel disease (IBD) is characterized by chronic inflammation of the entire gastrointestinal tract, although its etiology has largely been unclear. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A biological medicinal product that contains a version of the active substance of an already authorized biological medicinal product. Biosimilars of TNF inhibitors, such as CT-P13, are thought to possess equal efficacy and safety to the original with a lower cost, so switching from the original to a biosimilar considered an acceptable treatment. While several serious adverse reactions of TNF inhibitors have been reported, drug-induced liver injury (DILI) is uncommon, and liver dysfunction due to the administration of CT-P13 has not been reported in IBD patients. We herein report the first case of DILI due to CT-P13 after switching from original infliximab (O-IFX) in a patient","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42482900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A survey on self-medication for the prevention or treatment of COVID-19 and distrust in healthcare of veterans in a primary care setting in the United States.","authors":"Eva Amenta,&nbsp;Larissa Grigoryan,&nbsp;Laura Dillon,&nbsp;Casey Hines-Munson,&nbsp;John Van,&nbsp;Barbara Trautner","doi":"10.1177/20420986221143265","DOIUrl":"https://doi.org/10.1177/20420986221143265","url":null,"abstract":"<p><strong>Background: </strong>The SARS-CoV-2 (COVID-19) pandemic brought the public overwhelming and conflicting information. Rates of trust in healthcare professionals have been declining among laypersons over the past five decades. In this setting, we sought to evaluate the use of medications, both with or without a prescription, to prevent and treat SARS-CoV-2 as well as trust in healthcare among patients in a primary care clinic.</p><p><strong>Design: </strong>We surveyed 150 veterans in primary care clinic waiting rooms at a large southwestern tertiary care Veterans Affairs hospital. This survey was performed in March-November 2021.</p><p><strong>Methods: </strong>The survey asked about respondents' demographics, use of medications, nutritional supplements, and other remedies for the prevention and treatment of COVID-19, perceived access to care using Agency for Healthcare Research and Quality (AHRQ) Consumer Assessment of Healthcare Providers and System (CAHPS), overall health status, and barriers to medical appointments in the last 12 months. Distrust was measured using the Revised Health Care Distrust scale. We used univariate and multivariate linear regression analyses to study predictors of distrust to healthcare.</p><p><strong>Results: </strong>Forty-two (28%) of 150 respondents reported taking an agent for the prevention of COVID-19, while 4% reported storing antibiotics for the treatment of COVID-19, if diagnosed. Medications were obtained from medical providers, US stores or markets, the Internet, home stockpiles, and other countries. Medications with potentially harmful effects taken for the prevention and treatment of COVID-19 included hydroxychloroquine, pseudoephedrine, and antibiotics. Among those surveyed, the mean (SD) on the health system distrust score was 2.2 (0.6) on a scale of 1-5, with 5 indicating higher distrust. Younger age, self-reported poor health, lack of a regular physician, and self-reported poor access to care were independently associated with distrust in healthcare.</p><p><strong>Conclusion: </strong>Self-medication to prevent COVID-19 infection with unproven therapies was common among respondents, as was some level of distrust in the healthcare system. Access to care was one of the modifiable factors associated with distrust. Future studies may explore whether improving trust may moderate self-treatment behavior and storage of potentially harmful medications.</p><p><strong>Plain language summary: </strong><b>Self-Medication Habits and Trust in Healthcare Among Patients in a Primary Care Setting in the United States</b> The public has received information from many different sources on COVID-19. Trust in healthcare leadership has also been impacted. We studied self-medication habits to prevent or treat COVID-19 among a group of primary care patients in a large hospital system in the Southwest United States. We also explored these patients' trust in their healthcare system.We asked people waiting in primary","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e4/49/10.1177_20420986221143265.PMC9760501.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10763674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of triazole antifungals: a pharmacovigilance study from 2004 to 2021 based on FAERS.","authors":"Shuang Chai,&nbsp;Jing-Lun Zhan,&nbsp;Li-Mei Zhao,&nbsp;Xiao-Dong Liu","doi":"10.1177/20420986221143266","DOIUrl":"https://doi.org/10.1177/20420986221143266","url":null,"abstract":"<p><strong>Background: </strong>Triazole antifungals are widely used as broad-spectrum antifungal activity; however, there are many undetected and unreported adverse events (AEs).</p><p><strong>Methods: </strong>Data from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter (Q1) of 2004 to the third quarter (Q3) of 2021 were selected for disproportionality analysis to assess the connection between antifungal triazoles, and AEs and important medical events (IMEs).</p><p><strong>Results: </strong>A total of 22,566 records associated with triazole antifungals were identified, with 9584 triazole antifungal-IME pairs. The following system organ classes (SOCs) appeared as significant signals: 'Endocrine disorders' [reported odds ratio (ROR) = 167.94], 'Metabolism and nutrition disorders' (ROR = 46.30), and 'Skin and subcutaneous tissue disorders' (ROR = 21.37). Strong signals were observed with respiratory failure, rash, hepatic function abnormal, and hypokalemia. Uncommon security signals included a change in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucinations.</p><p><strong>Conclusion: </strong>Various triazole antifungals cause AEs of different types and intensities of association. Our results are broadly consistent with prescribing information and previous studies; however, additional pharmacoepidemiological studies are required to verify AEs with modest incidence but high signal.</p><p><strong>Plain language summary: </strong><b>A study on the adverse effects of triazole antifungals</b> <b>Introduction:</b> The triazole antifungals we studied include fluconazole, itraconazole, voriconazole, posaconazole, and isavuconazole. Triazole antifungals are widely used as broad-spectrum antifungals; however, there are many undetected and unreported adverse events (AEs).<b>Materials and Methods:</b> The Food and Drug Administration Adverse Event Reporting System (FAERS) database contains AEs reported to the FDA by different countries regarding post-marketing drugs. Through the FAERS database, we retrieved a total of 22,566 AE reports related to triazole antifungals. We not only counted information about patients' gender, age, weight, reporting country, outcome indicators, and indications but also analyzed the system organ classes (SOCs) of AEs, and the number of reported drug-related AEs and the degree of relevance.<b>Results:</b> We found a total of 22,566 records related to triazole antifungal agents, of which 9584 reports made important medical events (IMEs) about triazole antifungal agents, which are serious AEs. The following SOCs appear as important signals: 'endocrine disorders', 'metabolic and nutritional disorders', and 'skin and subcutaneous tissue disorders'. Triazole antifungals produce AEs, such as respiratory failure, rash, hepatic function abnormal, and hypokalemia. They also produce uncommon AEs, including changes in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucin","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/95/a3/10.1177_20420986221143266.PMC9761248.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10420306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The response to the COVID-19 pandemic trusted in pharmacovigilance to diminish communication risk","authors":"Gustavo-Adolfo Quintero","doi":"10.1177/20420986221088650","DOIUrl":"https://doi.org/10.1177/20420986221088650","url":null,"abstract":"Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Background SARS-CoV-2 is one of the most disruptive events in recent history and has become a threat to global health, perhaps the most important one in the world (along with Spanish flu) since the concept of pandemic had been introduced into the public health, approximately a century1 ago.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44570269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ten-year trends in adverse drug reaction–related hospitalizations among people with dementia","authors":"Anum Saqib Zaidi, G. Peterson, L. Bereznicki, C. Curtain, M. Salahudeen","doi":"10.1177/20420986221080796","DOIUrl":"https://doi.org/10.1177/20420986221080796","url":null,"abstract":"Aim: Trends in the incidence of adverse drug reaction (ADR)–related hospitalizations have been studied in the general population, but not specifically in people with dementia. This study aimed to investigate trends in the incidence of ADR-related hospitalizations among people with dementia, and identify the most commonly implicated drugs and diagnoses in these admissions. Methods: This study utilized the administrative data of all adults admitted to the four major public hospitals of Tasmania, Australia, with a primary or secondary diagnosis of dementia from July 2010 to December 2019. ADR-related hospitalizations were identified by using diagnosis-based and external cause codes. The Cochran–Armitage test was used to examine trends in the incidence of ADR-related hospitalizations. Results: Of the 7552 people with dementia admitted to the hospital at least once within the study period, 1775 (23.5%) experienced at least one ADR-related hospitalization. The estimated annual incidence of ADR-related hospitalizations increased 18% (1484–1760 per 100,000 population with dementia, p for trend <0.05) from 2010 to 2019. For those ADR-related admissions with a drug code recorded, 19.3% were due to antithrombotics and 11.5% to antihypertensives. The most frequent ADR-related admission diagnoses were renal diseases (72.9%). Length of hospital stay and in-hospital mortality were both significantly greater for ADR-related, relative to non-ADR-related, admissions (median 7 versus 5 days and 11% versus 6.7%, respectively; p < 0.001). Conclusion: The annual incidence of ADR-related hospitalizations in people with dementia increased between 2010 and 2019. Antithrombotics were the most commonly implicated drug class. The ADR-related hospitalizations were associated with increased length of stay and greater mortality. Plain Language Summary Adverse drug reaction–related hospitalizations among people with dementia Introduction: This study aimed to investigate trends in hospitalizations associated with medication problems among people with dementia, and identify the most commonly implicated drugs and diagnoses in these admissions. Methods: This study utilized the administrative data of all adults admitted to the four major public hospitals of Tasmania, Australia, with dementia from July 2010 to December 2019. Results: The annual incidence of hospitalizations associated with medication problems among people with dementia increased nearly 20% over 10 years. The length of hospital stay and in-hospital mortality were significantly greater for hospitalizations related to medication problems. Conclusion: The incidence of hospitalizations associated with medication problems in people with dementia increased between 2010 and 2019.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45588709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The 5th European pharmacovigilance congress: speaker abstracts","authors":"","doi":"10.1177/20420986211068914","DOIUrl":"https://doi.org/10.1177/20420986211068914","url":null,"abstract":"","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46952311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neurodevelopmental outcomes in children exposed prenatally to levetiracetam","authors":"B. A. Alsfouk","doi":"10.1177/20420986221088419","DOIUrl":"https://doi.org/10.1177/20420986221088419","url":null,"abstract":"Some old antiseizure medications (ASMs) pose teratogenic risks, including major congenital malformations and neurodevelopmental delay. Therefore, the use of new ASMs in pregnancy is increasing, particularly lamotrigine and levetiracetam. This is likely due to evidence of low risk of anatomical teratogenicity for both lamotrigine and levetiracetam. Regarding neurodevelopmental effects, lamotrigine is the most frequently investigated new ASM with information available for children up to 14 years of age. However, fewer data are available for the effects of levetiracetam on cognitive and behavioral development, with smaller cohorts and shorter follow-up. The aim of the present review was to explicate neurodevelopmental outcomes in children exposed prenatally to levetiracetam to support clinical decision-making. The available data do not indicate an increased risk of abnormal neurodevelopmental outcomes in children exposed prenatally to levetiracetam. Findings demonstrated comparable outcomes for levetiracetam versus controls and favorable outcomes for levetiracetam versus valproate on global and specific cognitive abilities, and behavioral problems. In addition, the available evidence shows no significant dose-effect association for levetiracetam on neurodevelopmental outcomes. However, this evidence cannot be determined definitively due to the limited numbers of exposures with relatively short follow-up. Therefore, further research is required. Plain Language Summary Antiseizure medications (ASMs) are medicines that inhibit the occurrence of seizures. Levetiracetam is a new ASM. Some old ASMs are linked with an increased risk of physical birth abnormalities and adverse effects on the child’s brain development. Therefore, the use of new ASMs in pregnancy is increasing, especially lamotrigine and levetiracetam. This is likely due to evidence of low risk of birth abnormalities for both lamotrigine and levetiracetam. Regarding effects on development of the brain, lamotrigine is the most frequently examined new ASM with information available for children up to 14 years of age. However, fewer data are available for the effects of levetiracetam on cognitive and behavioral development. Also, levetiracetam studies were smaller and shorter compared with studies investigating lamotrigine effects. The aim of this article was to review the child’s brain development effects after exposure to levetiracetam during pregnancy. The available data do not suggest an increased risk of the child having learning or thinking difficulties. Findings demonstrated comparable outcomes for levetiracetam versus controls (i.e. children unexposed to levetiracetam), and favorable outcomes for levetiracetam versus valproate. In addition, the available evidence shows no link between the higher dose of levetiracetam and an increased risk of adverse effects on the child’s brain development. However, this evidence cannot be determined definitively due to the limited numbers of children ex","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45737416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in potentially inappropriate opioid prescribing and associated risk factors among Korean noncancer patients prescribed non-injectable opioid analgesics.","authors":"Yoojin Noh,&nbsp;Kyu-Nam Heo,&nbsp;Yun Mi Yu,&nbsp;Ju-Yeun Lee,&nbsp;Young-Mi Ah","doi":"10.1177/20420986221091001","DOIUrl":"https://doi.org/10.1177/20420986221091001","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to investigate trends in the prevalence of potentially inappropriate opioid prescribing (PIOP) and identify potential risk factors among Korean noncancer patients.</p><p><strong>Methods: </strong>We conducted a cross-sectional study of annual national patient sample data from the Korean Health Insurance Review and Assessment Service (HIRA-NPS) for the period 2012-2018. Noncancer patients who were prescribed non-injectable opioid analgesics (NIOAs) at least once were included. The proportion of patients with at least one PIOP in terms of concurrent use of benzodiazepines or gabapentinoids, substance use disorder, treatment duration, and dosage was evaluated. Multivariable logistic regression was performed to identify the risk factors associated with PIOP.</p><p><strong>Results: </strong>Of the 9,772,503 noncancer patients, 1,583,444 (16.2%) were prescribed NIOAs at least once. Among them, 15.7% were exposed to PIOP, and the prevalence was much higher (31.6%) in the elderly group (age: ⩾65 years). The prevalence of PIOP increased 1.1-fold over 7 years (14.8-16.8%) among the total NIOA users and was more pronounced in non-tramadol NIOA users (a 1.5-fold increase, from 13.2% to 19.4%). Multivariable logistic regression indicated that older age, beneficiaries of medical aid or national meritorious service, exposure to polypharmacy, psychological disorder, chronic pain indication, and concomitant sedative use were independently associated with higher odds of PIOP.</p><p><strong>Discussion and conclusion: </strong>We found that the prevalence of PIOP was 15.7% among Korean noncancer patients, and it increased over the 7-year study period. This increasing trend is alarming because it was more drastic with non-tramadol NIOAs compared with that with tramadol. Several patient-level risk factors associated with PIOP would be useful in targeted management strategies for the safe use of opioids.</p><p><strong>Plain language summary: </strong><b>Potentially inappropriate opioid prescribing and related risk factors among noncancer patients prescribed non-injectable opioids in Korea</b> In Korea, the prevalence of non-injectable opioid analgesic (NIOA) use in noncancer patients steadily increased from 15.3% in 2012 to 17.1% in 2018.Also, the prevalence of potentially inappropriate opioid prescribing (PIOP) increased from 14.8% in 2012 to 16.8% in 2018.The following factors were associated with a markedly increased risk of PIOP: age, beneficiaries of medical aid or national meritorious service, polypharmacy, psychological disorder, chronic pain, and concomitant medications.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ff/a7/10.1177_20420986221091001.PMC9058459.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10615154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of drug-induced hand-foot syndrome using a spontaneous reporting system database.","authors":"Yu Yoshida,&nbsp;Sayaka Sasaoka,&nbsp;Mizuki Tanaka,&nbsp;Kiyoka Matsumoto,&nbsp;Misaki Inoue,&nbsp;Riko Satake,&nbsp;Kazuyo Shimada,&nbsp;Ririka Mukai,&nbsp;Takaaki Suzuki,&nbsp;Mari Iwata,&nbsp;Fumiya Goto,&nbsp;Takayuki Mori,&nbsp;Koki Mori,&nbsp;Tomoaki Yoshimura,&nbsp;Mitsuhiro Nakamura","doi":"10.1177/20420986221101963","DOIUrl":"https://doi.org/10.1177/20420986221101963","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of our study was to assess the clinical features of hand-foot syndrome (HFS) associated with certain systemic chemotherapeutic drugs in a real-world setting using the Japanese Adverse Drug Event Report (JADER) database.</p><p><strong>Methods: </strong>HFS was defined using the preferred terms from the Medical Dictionary for Regulatory Activities. We used several indices, such as the reporting odds ratios (RORs) at 95% confidence interval (CI), the time-to-onset profile of HFS, and cluster analysis.</p><p><strong>Results: </strong>Of 646,779 reports (submission period: April 2004 to September 2020), 1814 reported HFS events. The RORs (95% CI) for axitinib, capecitabine, lapatinib, regorafenib, sorafenib, and sunitinib were 14.9 (11.1-20.1), 54.6 (49.2-60.6), 130.4 (110.7-153.6), 63.3 (55.2-72.6), 29.0 (25.8-32.7), and 13.9 (11.7-16.5), respectively. The analysis of time-to-onset profiles revealed that the median values (interquartile range: 25.0-75.0%) of drug-induced HFS caused by capecitabine, cisplatin, docetaxel, everolimus, regorafenib, sorafenib, and trastuzumab were 21.0 (13.0-42.0), 15.0 (10.0-82.0), 6.0 (3.0-25.0), 86.5 (67.0-90.5), 9.0 (6.0-14.0), 9.0 (6.0-14.0), and 70.0 (15.0-189.0) days, respectively. The number of clusters was set to 4. Among these, one cluster, which included capecitabine, regorafenib, and lapatinib, exhibited a higher reporting ratio and ROR of drug-induced HFS than other drugs.</p><p><strong>Conclusions: </strong>The RORs and results of time-to-onset analysis obtained in this study indicated the potential risk of HFS associated with chemotherapeutic drugs. Our results suggest that health care professionals must be aware of the potential onset of drug-induced HFS with docetaxel, regorafenib, and sorafenib for at least 4 weeks; therefore, careful observation is recommended.</p><p><strong>Plain language summary: </strong><b>Elucidation of the relationship between cancer drugs and risk of hand-foot syndrome:</b> <b>Purpose:</b> Hand-foot syndrome (HFS) is an adverse effect of some cancer drugs, which is characterized by symptoms such as redness, swelling, blistering, and pain in the area of palms and soles. HFS reduces the quality of life of patients and can sometimes interfere with anticancer treatment plans. It is important to understand the clinical manifestations of HFS and gain knowledge that will allow for early intervention by clinicians.<b>Methods:</b> In this study, we used a large-scale side effect database of real-world cases for a comprehensive investigation of anticancer-drug-induced HFS. The database contained 646,779 adverse event reports from April 2004 to September 2020; among which, we identified 1814 HFS events. Using these data, we could obtain information on the relationship between 19 types of anticancer drugs and HFS, and the onset time of HFS and HFS prognosis related to each anticancer drug. <b>Results:</b> Our results suggest that clinicians should monitor","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/46/5d/10.1177_20420986221101963.PMC9136434.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10619326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prescription for COVID-19 by non-medical professionals during the pandemic in Colombia: a cross-sectional study","authors":"María José Niño-Orrego, Daniela Baracaldo-Santamaría, Claudia Patricia Ortiz, Heyde Patricia Zuluaga, Sthefany Alejandra Cruz-Becerra, F. Soler, Andrés M. Pérez-Acosta, Daniel Ricardo Delgado, C. Calderón-Ospina","doi":"10.1177/20420986221101964","DOIUrl":"https://doi.org/10.1177/20420986221101964","url":null,"abstract":"Background: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, and hydroxychloroquine that are not useful for preventing or treating COVID-19 and could expose patients to unnecessary adverse drug reactions (ADRs), drug-drug interactions (DDIs), disease masking, and antibiotic resistance. Rationale: SM with drugs advertised for COVID-19 can have consequences, and people should be aware of approved uses, potential contraindications, and ADRs. Thus, the aim of this study was to know the drug therapies including natural products and homeopathic drugs offered by Colombian pharmaceutical establishments for the prevention and treatment of COVID-19, as well as the information provided on the safe use of the product. Methods: An observational, cross-sectional mystery shopping study was carried out to determine the pharmaceutical alternatives for the management of COVID-19 offered by pharmaceutical establishments (drugstores, pharmacies, homeopathic pharmacies, and nutritional supplements stores) in Colombia, and information related to the safe use of the product. The study included 482 pharmaceutical establishments from 16 Colombian departments. Data collection was done through telephone calls to each of the establishments following an interview protocol pretending to be a patient who presents symptoms related to COVID-19. Results: About 57.3% (276) of the establishments recommended a product for the treatment of COVID-19 infection, 66.6% (321) asked whether the caller had COVID-19 symptoms and what they are, and 44.2% (213) suggested taking a COVID-19 test. Of 59 drugs suggested by pharmacies, the most recommended were azithromycin, ivermectin, acetaminophen, ibuprofen, and ASA (aspirin). From the establishments that recommended a product, dosage was indicated in 85.5% (236) of the pharmaceutical establishments and 14.5% (40) of the establishments reported the most common adverse effects of this substance. About 9.4% (26) of the establishments reported possible interactions of the recommended drugs and substances with food, beverages, or supplements.Conclusion: Pharmaceutical establishments in Colombia seem to have significantly contributed to self-medication for COVID-19 in Colombia during the pandemic. This behavior is inappropriate, since the mild forms of the disease do not have a specific treatment. Plain Language Summary Self-medication induced by pharmaceutical establishments in Colombia during the COVID-19 pandemic Background: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, hydroxychloroquine among others, which are not useful for preventing or treating COVID-19 and could expose patients to unnecessary","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49320233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}