Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230601162144
Sree Sudha Tanguturi Yella, Kota Sesha Brahma Sri Krishna Sasanka, Harminder Singh, Bhumika Meena
{"title":"A Routine over the Counter Phenylephrine Causing Rarer Drug Eruption as Adverse Drug Reaction - A Case Report.","authors":"Sree Sudha Tanguturi Yella, Kota Sesha Brahma Sri Krishna Sasanka, Harminder Singh, Bhumika Meena","doi":"10.2174/1574886318666230601162144","DOIUrl":"10.2174/1574886318666230601162144","url":null,"abstract":"<p><strong>Background: </strong>Phenylephrine is a sympathomimetic, which means it acts analogous to adrenaline. Phenylephrine can be taken orally to treat nasal congestion symptoms. It is also frequently mixed with other medicines in products meant to relieve cough and cold symptoms. Given the widespread usage of phenylephrine, related drug eruptions appear to be uncommon.</p><p><strong>Case presentation: </strong>Here we discuss a case of a 19-year-old female patient who reported to our hospital with blebs on the skin throughout her legs and torso. The drug eruption or adverse drug response was linked with itching, had a slow beginning, and progressed. Her medical history indicated that she had been taking phenylephrine 10 mg orally twice a day. On the sixth day, she experienced an adverse medication response caused by the medicine phenylephrine. Phenylephrine was stopped immediately and the other medications, such as levocetirizine, montelukast, and nasal spray, were continued. The patient was told not to use phenylephrine, either alone or in combination with FDCs. There are no other complaints. As a result, the patient was diagnosed with phenylephrine- induced eruption.</p><p><strong>Conclusion: </strong>We present this case to highlight the importance of inspiring a pharmacovigilance mindset among all clinicians providing care as a routine alert drug, phenylephrine-induced drug eruption.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"291-294"},"PeriodicalIF":1.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9565550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/0115748863273507231116112824
Atul Khurana, Harikesh Dubey, Mandeep Kumar Arora
{"title":"Assessment of Neurologic Safety Profile of Immune Checkpoint Inhibitors: Evaluation of Adverse Drug Reaction Reports.","authors":"Atul Khurana, Harikesh Dubey, Mandeep Kumar Arora","doi":"10.2174/0115748863273507231116112824","DOIUrl":"10.2174/0115748863273507231116112824","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) used in immunotherapy have revolutionized cancer management. However, ICI therapy can come with serious neurologic risks.</p><p><strong>Objective: </strong>The objective of our study is to analyze the occurrence of neurologic events with ICIs.</p><p><strong>Methods: </strong>We referred to EudraVigilance (EV) and VigiAccess to evaluate the frequency of individual case safety reports (ICSRs), including neurologic events with ICIs. Data was gathered for a period from the date of ICI's marketing authorization till 30 January 2023. The computational assessment was conducted with the help of reporting odds ratio (ROR) and its 95% confidence interval (CI).</p><p><strong>Results: </strong>Overall, 8181 ICSRs in EV and 15905 ICSRs from VigiAccess were retrieved for neurologic events, with at least one ICI as the suspected drug. The majority of the ICSRs were reported for nivolumab, pembrolizumab, and ipilimumab, whereas frequently reported events were neuropathy peripheral, myasthenia gravis, seizure, Guillain-Barre syndrome, paraesthesia, syncope, encephalopathy, somnolence. Under EV, 92% of ICSRs were reported as serious, 10% included fatal outcomes, and nearly 61% cited patient recovery. Atezolizumab (ROR 1.64, 95% CI 1.75- 1.52), cemiplimab (ROR 1.61, 95% CI 1.98-1.3), and nivolumab (ROR 1.38, 95% CI 1.44-1.31) had a considerable increase in the frequency of ICSR reporting. Cerebrovascular accident, posterior reversible encephalopathy syndrome, tremor, and somnolence were identified as potential signals.</p><p><strong>Conclusion: </strong>ICIs were significantly associated with neurologic risks, which cannot be generalized. A considerable increase in ICSR reporting frequency was observed with atezolizumab, cemiplimab, and nivolumab, while avelumab, pembrolizumab, durvalumab, and cemiplimab were linked with four potential signals. These findings suggest the consideration of a revision of the neurologic safety profile of ICIs. Furthermore, the necessity for additional ad-hoc research is emphasized.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"382-394"},"PeriodicalIF":1.1,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139680752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230817162424
Paula Lana de Miranda Drummond, Roberta Márcia Marques Dos Santos, Lívia Pena Silveira, Jéssica Soares Malta, Adriano Max Moreira Reis, Naiane Lima Costa, Roberta Oliveira de Paula E Silva, Evandro Maranhão Fagundes, Cristiane Aparecida Menezes de Pádua
{"title":"Chemotherapy-Induced Peripheral Neuropathy Impacts Quality of Life and Activities of Daily Living of Brazilian Multiple Myeloma Patients.","authors":"Paula Lana de Miranda Drummond, Roberta Márcia Marques Dos Santos, Lívia Pena Silveira, Jéssica Soares Malta, Adriano Max Moreira Reis, Naiane Lima Costa, Roberta Oliveira de Paula E Silva, Evandro Maranhão Fagundes, Cristiane Aparecida Menezes de Pádua","doi":"10.2174/1574886318666230817162424","DOIUrl":"10.2174/1574886318666230817162424","url":null,"abstract":"<p><strong>Background: </strong>Survival in multiple myeloma (MM) has improved in the past years with the introduction of immunomodulators and proteasome inhibitors. However, chemotherapyinduced peripheral neuropathy (CIPN) is associated with both drug classes affecting Health- Related Quality of Life (HRQoL) and activities of daily living (ADL).</p><p><strong>Objective: </strong>We evaluated CIPN in MM patients to identify associated factors and impacts on HRQoL and ADL.</p><p><strong>Methods: </strong>This is a cross-sectional study with Brazilian patients from public and private health services. Patients were interviewed using validated tools to measure CIPN and HRQoL, along with sociodemographic and clinical questions. Logistic regression was used to assess the association of CIPN with sociodemographic, clinical, and HRQoL variables.</p><p><strong>Results: </strong>In total, 217 patients were eligible for the study. The median age was 67, 50.9% were women, 51.6% had low income, 47.5% had low education, and 55.3% attended private health services. The chemotherapy regimen most used was the combination of cyclophosphamide, thalidomide, and dexamethasone (17.5%) among the 24 types of regimens found. Most patients (90.3%) had at least one CIPN symptom: 62.7% were severe, and 51.62% were extremely bothered ADL. Numbness was the most common symptom (40.6%). CIPN was independently associated with education, hospitalization, chemotherapy, side effects, disease symptoms, and global health status in HRQoL.</p><p><strong>Conclusion: </strong>MM patients showed a high frequency of CIPN, which affected ADL and impaired HRQoL. Early and accurate detection of CIPN and dose management in patients with thalidomide and bortezomib-based regimens should be performed to provide better treatment outcomes and avoid permanent disabilities.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"356-367"},"PeriodicalIF":1.1,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10021606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230119101656
Nitin Joseph, Jeniya Jain
{"title":"Perception and Practices of Self-medication Practices among Health Science Students during the ongoing COVID-19 Pandemic in Mangalore, India.","authors":"Nitin Joseph, Jeniya Jain","doi":"10.2174/1574886318666230119101656","DOIUrl":"10.2174/1574886318666230119101656","url":null,"abstract":"<p><strong>Introduction: </strong>Health science students are prone to self-medication due to easy accessibility to medicines, background medical knowledge, and their ability to diagnose illnesses. The ongoing COVID-19 pandemic has further encouraged this practice due to the fear of contracting the virus by visiting healthcare establishments.</p><p><strong>Objectives: </strong>This study was conducted to assess the perception and practices of self-medication among health science students during the background of the COVID-19 pandemic.</p><p><strong>Methods: </strong>This cross-sectional study was conducted in July 2021 during the second wave of COVID-19. Data were collected using a Microsoft form circulated among students using WhatsApp or email.</p><p><strong>Results: </strong>The mean age of the 350 participants was 20.8 ± 1.5 years. About 165(47.1%) participants had self-medicated over the past one year. The most common mode of self-medication was using previous consultation notes [121(73.3%)]. The most common reason for self-medication stated was the mild nature of the illness [131(79.4%)]. Fifteen (9.1%) participants reported changes in medication from one to another during self-medication. Sixteen (9.7%) participants increased drug dosage during self-medication. Sixteen (26.2%) out of 61 participants who self-medicated with antibiotics did not complete the course. Forty-six (27.9%) out of the 165 participants were not aware of the adverse effects of the drugs being self-medicated on most occasions. One hundred and sixty seven (47.7%) of the total participants did not feel that self-medication practices are harmful. Ninety-five (27.1%) felt that self-medication practices are acceptable during the COVID-19 pandemic. Eighty-six (90.5%) of them thought so to avoid getting COVID-19 infection by visiting healthcare establishments. In multivariable analysis, participants in the final year and those with chronic morbidities were associated with self-medication practices.</p><p><strong>Conclusion: </strong>Self-medication practices were present among 47.1% of participants. More than onefourth of them were not aware of the side effects of self-medicated drugs on most occasions. About 47.7% participants felt that self-medication practices are not harmful and more than one-fourth of them felt that it was acceptable during the COVID-19 pandemic. Therefore, the students need to be made aware of the harmful consequences of self-medication.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"70-81"},"PeriodicalIF":1.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10545705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230525142152
Zainab Najim Abdul-Nabi, Noor Kadhim Mohamed-Jawad, Noor Yousif Fareed, Nadheerah Falih Neamah, Falah Hassan Shari
{"title":"Adverse Effects Post COVID-19 Vaccination and its Association with Age, Gender and Comorbid Disease in Basrah City Southern of Iraq.","authors":"Zainab Najim Abdul-Nabi, Noor Kadhim Mohamed-Jawad, Noor Yousif Fareed, Nadheerah Falih Neamah, Falah Hassan Shari","doi":"10.2174/1574886318666230525142152","DOIUrl":"10.2174/1574886318666230525142152","url":null,"abstract":"<p><strong>Background: </strong>Vaccination against COVID-19 virus is the most valuable tool available for protection during the pandemic of coronavirus. The clinical manifestation post-vaccination is a barrier to vaccination for many people in Iraq and worldwide.</p><p><strong>Objectives: </strong>The objective of this study is identifying various clinical manifestations occurring after receiving vaccines among individuals in Basrah Governorate. Moreover, we examine its association with respondents' demographics and the type of vaccine they received.</p><p><strong>Methods: </strong>A cross-section study was conducted in Basrah, southern Iraq. Research data were collected through an online questionnaire. The data were analyzed using both descriptive and analytic statistical tools using the SPSS program.</p><p><strong>Results: </strong>Most of the participants (86.68%) received the vaccine. The side effects were reported in 71.61% of vaccinated individuals. Fever and muscle pain were the two most experienced clinical manifestations, while lymph node enlargement and disturbances in taste and/or smell sensations were reported infrequently. Adverse effects were mostly reported with the Pfizer BioNTech vaccine receiver. Females and those in the younger age group also reported a significantly higher incidence of side effects.</p><p><strong>Conclusion: </strong>Most adverse effects related to the COVID-19 vaccine were minor and could be tolerated without the need for hospital admission.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"248-254"},"PeriodicalIF":1.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9521903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230417103423
Lucía González-Bravo, María-José Sánchez-González, José Barbarroja-Escudero, Josefa Monjo-Paz, Dorotea Matas-Dominguez, Melchor Alvarez-Mon
{"title":"Immediate Reaction to Propranolol: An Extremely Rare but Important Condition. A Case Report.","authors":"Lucía González-Bravo, María-José Sánchez-González, José Barbarroja-Escudero, Josefa Monjo-Paz, Dorotea Matas-Dominguez, Melchor Alvarez-Mon","doi":"10.2174/1574886318666230417103423","DOIUrl":"10.2174/1574886318666230417103423","url":null,"abstract":"<p><strong>Introduction: </strong>Beta-blockers involve a group of drugs widely used nowadays. Propranolol was the first beta-blocker available in the market. It is the most prescribed first-generation betablocker and is commonly used. Beta-blocker allergy is extremely unusual. Only an isolated case of an urticaria reaction to propranolol has been published in 1975.</p><p><strong>Case presentation: </strong>We present a 44-year-old man. In 2016, he was treated with a daily dose of 5 mg of propranolol prescribed for a diagnosis of essential tremor. On the third day of medical treatment, he experienced an episode of generalized urticaria directly related to the administration of propranolol. He continued with his habitual treatment and he had no other urticaria episodes. A drug provocation test was carried out with gradually increasing doses of the culprit drug. Thirty minutes after a total cumulative dose of 5 mg, the patient had several hives on the chest, abdominal region and arms. Two weeks later, a new drug provocation test was performed to bisoprolol as an alternative beta-blocker, with good tolerance.</p><p><strong>Conclusion: </strong>We describe a new case of urticaria secondary to propranolol, presenting as an immediate hypersensitivity reaction. Bisoprolol has been succesfully proved to be a safe option. Bisoprolol is a second-generation beta-blocker, it is available and commercialized worldwide, which makes it a good alternative.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"303-305"},"PeriodicalIF":1.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9388882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230420084701
Jakob Hasselstrøm Jensen, Peter Vestergaard, Morten Hasselstrøm Jensen
{"title":"Association between Glucose-lowering Treatments and Risk of Diabetic Retinopathy in People with Type 2 Diabetes: A Nationwide Cohort Study.","authors":"Jakob Hasselstrøm Jensen, Peter Vestergaard, Morten Hasselstrøm Jensen","doi":"10.2174/1574886318666230420084701","DOIUrl":"10.2174/1574886318666230420084701","url":null,"abstract":"<p><strong>Introduction: </strong>Glycaemic variability is possibly linked to the development of diabetic retinopathy, and newer second-line glucose-lowering treatments in type 2 diabetes might reduce glycaemic variability.</p><p><strong>Aim: </strong>This study aimed to investigate whether newer second-line glucose-lowering treatments are associated with an alternative risk of developing diabetic retinopathy in people with type 2 diabetes.</p><p><strong>Methods: </strong>A nationwide cohort of people with type 2 diabetes on second-line glucose-lowering treatment regimens in 2008-2018 was extracted from the Danish National Patient Registry. Adjusted time to diabetic retinopathy was estimated with a Cox Proportional Hazards model. The model was adjusted for age, sex, diabetes duration, alcohol abuse, treatment start year, education, income, history of late-diabetic complications, history of non-fatal major adverse cardiovascular events, history of chronic kidney disease, and history of hypoglycaemic episodes.</p><p><strong>Results: </strong>Treatment regimens of metformin + basal insulin (HR: 3.15, 95% CI: 2.42-4.10) and metformin + glucagon-like peptide-1 receptor agonist (GLP-1-RA, HR: 1.46, 95% CI: 1.09-1.96) were associated with an increased risk of diabetic retinopathy compared with metformin + dipeptidyl peptidase-4 inhibitors (DPP-4i). Treatment with metformin + sodium-glucose cotransporter-2 inhibitor (SGLT2i, HR: 0.77, 95% CI: 0.28-2.11) was associated with the numerically lowest risk of diabetic retinopathy compared with all regimens investigated.</p><p><strong>Conclusion: </strong>Findings from this study indicate that basal insulin and GLP-1-RA are suboptimal second- line choices for people with type 2 diabetes at risk of developing diabetic retinopathy. However, many other considerations concerning the choice of second-line glucose-lowering treatment for type 2 diabetes patients should be taken into account.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"236-243"},"PeriodicalIF":1.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9441706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230725101846
Ons Charfi, Ghozlane Lakhoua, Khouloud Berrim, Sarrah Kastalli, Talel Badri, Imen Aouinti, Riadh Daghfous, Ahmed Zaiem, Sihem El Aidli
{"title":"Erythema Multiforme Reactions Following Pfizer/BioNTech (Tozinameran) Vaccination: Two Case-Reports with Positive Rechallenge and Review of the Literature.","authors":"Ons Charfi, Ghozlane Lakhoua, Khouloud Berrim, Sarrah Kastalli, Talel Badri, Imen Aouinti, Riadh Daghfous, Ahmed Zaiem, Sihem El Aidli","doi":"10.2174/1574886318666230725101846","DOIUrl":"10.2174/1574886318666230725101846","url":null,"abstract":"<p><strong>Aim: </strong>Pfizer/BioNTech (BNT162b2) is a COVID-19 vaccine with a reassuring safety profile. The main adverse reactions are mild local reactions. Cutaneous reactions are generally minor. The most common cutaneous reaction reported was a local injection-site reaction.</p><p><strong>Case study: </strong>Here we present 2 cases of erythema multiform (EM) following BNT162b2 vaccination with positive rechallenge. The 1<sup>st</sup> case was about a 51-year-old woman who developed 5 days after the 1st dose of the mRNA Pfizer/BioNTech (BNT162b2) a macular, erythematous, roundshaped lesions on the hands, knees and soles. She experienced a positive rechallenge one month later. In the 2<sup>nd</sup> case, a 55-year-old man presented 6 days following the 2<sup>nd</sup> shot of the mRNA Pfizer/ BioNTech (BNT162b2), targetoid eruption on the upper and lower members. The patient reported that he had the same skin lesions in ankles and soles few days following the 1<sup>st</sup> shot of the same vaccine.</p><p><strong>Conclusion: </strong>Few cases of EM following COVID-19 vaccination were reported in the literature and positive rechallenge in only one case. Rechallenge was not performed in most cases. Our two cases are particular because of the positive rechallenge in both patients. This is the gold standard to confirm that the vaccine was the culprit agent in inducing EM.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"465-468"},"PeriodicalIF":1.1,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9866240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230731151447
Richard H Woods
{"title":"Dental Disorders Reported to the FDA Adverse Event Reporting System in Association with Buprenorphine: An Analysis by Ingredient Composition and Route of Administration.","authors":"Richard H Woods","doi":"10.2174/1574886318666230731151447","DOIUrl":"10.2174/1574886318666230731151447","url":null,"abstract":"<p><strong>Background: </strong>Prior research has suggested buprenorphine-containing medications may be associated with an increased risk of dental disorders. However, published data describing adverse dental reactions in buprenorphine users by active ingredient composition and route of administration are limited.</p><p><strong>Objective: </strong>The purpose of this study was to evaluate the influence of formulation on spontaneous reporting of dental disorders among patients treated with buprenorphine.</p><p><strong>Methods: </strong>Adverse event reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) between 2015 and 2022 were analyzed. Reporting odds ratios (ROR) and 95% confidence intervals (CI) were calculated to measure disproportionality of dental disorder reporting as classified by 39 Medical Dictionary for Regulatory Activities preferred terms.</p><p><strong>Results: </strong>Compared to pooled reports for all other drugs across FAERS, both buprenorphine monotherapy (ROR 3.09; 95% CI 2.61-3.66) and combination buprenorphine/naloxone (ROR 14.61; 95% CI 13.34-16.01) were associated with positive disproportionality signals. Signals of disproportionate dental disorder reporting were also detected for buprenorphine medicines administered by sublingual (ROR 20.03; 95% CI 18.04-22.24), buccal (ROR 4.46; 95% CI 3.00-6.61) and oral (ROR 7.17; 95% CI 5.03-10.22) routes, but not for other modalities. In considering active ingredient and route together, sublingual buprenorphine monotherapies (ROR 23.55; 95% CI 17.84-31.11) and sublingual buprenorphine/naloxone (ROR 19.47; 95% CI 17.39-21.80) were each associated with disproportionate reporting of dental disorders.</p><p><strong>Conclusion: </strong>Subject to the limitations of spontaneous adverse event data, this study identified significantly disproportionate reporting of dental disorders to FAERS among patients treated with buprenorphine- containing medications, including formulations administered by sublingual, buccal and oral routes. These findings are consistent with prior data and suggest that regular oral care and proper dental hygiene be emphasized for patients undergoing therapy with orally dissolving buprenorphine.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"261-267"},"PeriodicalIF":1.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9912080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230824155341
Aysu Sinem Koc, Orcun Can, Senol Kobak
{"title":"Atezolizumab Lung Toxicity: Importance of Combination Treatment On The Edge of Life, A Case Report.","authors":"Aysu Sinem Koc, Orcun Can, Senol Kobak","doi":"10.2174/1574886318666230824155341","DOIUrl":"10.2174/1574886318666230824155341","url":null,"abstract":"<p><strong>Background: </strong>Lung cancer is one of the most common and mortal cancers worldwide. According to pathological and clinical groups, treatments vary, and a tailored approach is considered. Adjuvant therapies, such as chemotherapy, radiation, and immune checkpoint inhibitors (ICI), are recommended by recent guidelines for patients with locally advanced cancer.</p><p><strong>Objective: </strong>This study aimed to report the case of a patient with stage 2B squamous cell lung carcinoma who was managed for pulmonary toxicity after receiving adjuvant chemotherapy and atezolizumab treatment.</p><p><strong>Case report: </strong>A 66-year-old male patient received chemotherapy and immunotherapy after surgery for squamous cell lung cancer. A diagnosis of atezolizumab-associated pneumonitis was made using laboratory tests and imaging due to the patient's worsening dyspnea after treatment. Due to the patient's rapid progression, pulse steroid and MMF therapy were administered concurrently. When Klebsiella pneumoniae growth was detected in the sputum culture during the follow-up, IVIg was used to supplement the medication. The patient showed significant clinical and radiological improvement.</p><p><strong>Conclusion: </strong>In this study, we present an atezolizumab-induced pneumonitis case of a squamous cell lung cancer patient. It may be life-saving not to avoid aggressive treatment approaches by combining the steps of guideline recommendations in patients with rapidly progressive pneumonitis.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"469-473"},"PeriodicalIF":1.1,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10124100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}