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[Nocebo, informed consent and doctor-patient communication].

Nervenarzt. 2020 Jul 29;:

Authors: Hansen E, Zech N, Benson S

Abstract
Negative previous experiences (conditioning), observational learning and expectations can trigger nocebo effects. They are responsible for a substantial proportion of the side effects of medical treatment, and are induced primarily by risk information for informed consent. This has been demonstrated in studies on patient groups with or without modified medical information. Drug trials in the field of neurology and psychiatry have regularly revealed side effects and drop-out also in placebo groups. The underlying neurobiological mechanisms were experimentally investigated especially for nocebo-induced hyperalgesia, whereby the specifically involved regions of the brain could be identified by functional imaging as well as changes in the dopamine, endorphin and cholecystokinin systems. Nocebo effects are specific, i.e. they are closely related to patient information and can induce or aggravate exactly the symptoms addressed. Nevertheless, informed consent is an essential part of doctor-patient communication; however, information on risks can be markedly less damaging when unnecessary repetitions are avoided, misunderstandings are recognized or resolved and several different options are given. In addition, risks should always be named together with positive aspects, such as the advantages of the appropriate treatment, the prophylactic measures applied or the early detection and treatment of developing side effects. The best protection against harm caused by information on risks is a trustful doctor-patient relationship. Poor knowledge of nocebo effects or lack of countermeasures constitute a serious threat to patients and according to the current state of knowledge could be rated as medical malpractice.

PMID: 32728796 [PubMed - as supplied by publisher]

Insights into the Mechanism of Action of Highly Diluted Biologics.

J Immunol. 2020 Jul 29;:

Authors: Tarasov SA, Gorbunov EA, Don ES, Emelyanova AG, Kovalchuk AL, Yanamala N, S Schleker AS, Klein-Seetharaman J, Groenestein R, Tafani JP, van der Meide P, Epstein OI

Abstract
The therapeutic use of Abs in cancer, autoimmunity, transplantation, and other fields is among the major biopharmaceutical advances of the 20th century. Broader use of Ab-based drugs is constrained because of their high production costs and frequent side effects. One promising approach to overcome these limitations is the use of highly diluted Abs, which are produced by gradual reduction of an Ab concentration to an extremely low level. This technology was used to create a group of drugs for the treatment of various diseases, depending on the specificity of the used Abs. Highly diluted Abs to IFN-γ (hd-anti-IFN-γ) have been demonstrated to be efficacious against influenza and other respiratory infections in a variety of preclinical and clinical studies. In the current study, we provide evidence for a possible mechanism of action of hd-anti-IFN-γ. Using high-resolution solution nuclear magnetic resonance spectroscopy, we show that the drug induced conformational changes in the IFN-γ molecule. Chemical shift changes occurred in the amino acids located primarily at the dimer interface and at the C-terminal region of IFN-γ. These molecular changes could be crucial for the function of the protein, as evidenced by an observed hd-anti-IFN-γ-induced increase in the specific binding of IFN-γ to its receptor in U937 cells, enhanced induced production of IFN-γ in human PBMC culture, and increased survival of influenza A-infected mice.

PMID: 32727888 [PubMed - as supplied by publisher]

Vigilance of Drug-Drug interactions to Mitigate ADRs: Front and Center for Pharmacists.

Sr Care Pharm. 2020 Aug 01;35(8):336-337

Authors: Beier MT

Abstract
As the number of people taking multiple medications increases, differing approaches to address drug-drug interactions and adverse drug reactions have been debated-but not solved-despite excellent criteria to stop the use of potentially inappropriate medications.

PMID: 32718388 [PubMed - indexed for MEDLINE]

Adverse Drug Reactions Are Everyone's Business.

Sr Care Pharm. 2020 Aug 01;35(8):332-333

Authors: Alderman C

Abstract
Why has it been so difficult to gain traction in reducing the serious consequences of adverse drug reactions (ADRs), particularly among the people who are most vulnerable? Pharmacists have a unique place in the clinical setting as the advocates for the adoption of evidence-based care, and they are the well-placed clinical professionals who can detect ADRs and provide guidance about how to address them.

PMID: 32718386 [PubMed - indexed for MEDLINE]

Use of Risk Evaluation and Mitigation Strategies by the US Food and Drug Administration, 2008-2019.

JAMA. 2020 07 21;324(3):299-301

Authors: Guadamuz JS, Qato DM, Alexander GC

PMID: 32692379 [PubMed - indexed for MEDLINE]

Impact of Lopinavir/Ritonavir and Efavirenz-Based Antiretroviral Therapy on the Lipid Profile of Chinese HIV/AIDS Treatment-Naïve Patients in Beijing: A Retrospective Study.

Curr HIV Res. 2019;17(5):324-334

Authors: Dai L, Liu A, Zhang H, Wu H, Zhang T, Su B, Shao Y, Li J, Ye J, Scott SR, Mahajan SD, Schwartz SA, Yu H, Sun L

Abstract
BACKGROUND: Antiretroviral therapy (ART) is associated with lipid abnormalities that contribute to increased risk of cardiovascular (CV) events among patients with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). Although disorders of lipid metabolism associated with ART have been described before in developed countries, data on lipid profile disorders associated with ART use in China are limited. This study aimed to examine the changes in lipid profile among patients with HIV/AIDS who initiated lopinavir/ritonavir LPV/r or efavirenz (EFV)-based antiretroviral treatment regimens, which continue to be widely used China and other developing countries.
METHODS: This is a retrospective, matched case-control study of HIV-positive patients initiating either LPV/r or EFV regimens at the Beijing You'an Hospital, Capital Medical University between July 2012 and January 2017. Generalized estimating equations were used to compare the differences in total cholesterol [TC], triglycerides [TG], low-density lipoprotein-cholesterol [LDL-C], and highdensity lipoprotein-cholesterol [HDL-C] at baseline and up to 24-months after ART initiation between the two treatment arms.
RESULTS: Baseline characteristics, including age, sex, CD4 cell count, viral load, and serum lipids, which were comparable between the two groups. The LPV/r-based regimen group had increased TC, TG, HDL-C, and LDL-C after 24-months of treatment. In the EFV-regimen group, TC, HDL-C, and LDL-C were increased compared to baseline, while the TC/HDL-C ratio decreased, and TG did not change significantly. After 24-months of treatment, the percentage of patients with dyslipidemia in the LPV/r group was much higher than in the EFV group (84.0% vs. 52.6%, P<0.001), and 17(10%) patients on LPV/r-based regimens had severe dyslipidemia. Patients on LPV/r-based regimens were at increased odds of hypercholesterolemia (odds ratio [OR]=1.709, P=0.038), hypertriglyceridemia (OR=4.315, P<0.001), and high TC/HDL-C ratio (OR=1.951, P=0.003). However, no significant difference was found in HDL-C (OR=1.246, P=0.186) or LDL-C (OR=1.253, P=0.410) between the treatment groups.
CONCLUSION: Both LPV/r or EFV treatment regimens impacted patients' lipid profiles. Compared to EFV-based regimens, patients on LPV/r-based regimens had increased odds of dyslipidemia, such as hypercholesterolemia, hypertriglyceridemia, or high TC/HDL-C ratio; however, there was no obvious effect on LDL-C, which is more relevant to the development of the cardiovascular disease.

PMID: 31654514 [PubMed - indexed for MEDLINE]

Erenumab Side Effects.

Headache. 2019 07;59(7):1088-1089

Authors: Robbins L

PMID: 31297805 [PubMed - indexed for MEDLINE]

Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug-Related Deaths.

Clin Transl Sci. 2019 07;12(4):408-415

Authors: Okubo TK, Ono S

Abstract
Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug-development pathways, in some of which "local" dose-ranging and/or pivotal phase III studies are skipped. We examined the association between the clinical development pathway and postmarketing safety in Japan for 177 new molecular entities approved between 2004 and 2013 focusing on dose setting histories for each drug. The risk of drug-related deaths was higher when companies did not conduct local (i.e., Japanese) dose-ranging studies and/or pivotal studies. Even when local dose-ranging studies were conducted, the risk remained higher in some drugs for which the approved dose in Japan was set equal to that in the United States. Drugs developed under a bridging strategy tended to show lower risks. These results suggested that local clinical studies may play a substantial role in achieving optimization of postmarketing drug use in each local target population.

PMID: 31016896 [PubMed - indexed for MEDLINE]

Broad Antibody and Cellular Immune Response from a Phase 2 Clinical Trial with a Novel Multivalent Poxvirus Based RSV Vaccine.

J Infect Dis. 2020 Jul 29;:

Authors: Jordan E, Lawrence SJ, Meyer TPH, Schmidt D, Schultz S, Mueller J, Stroukova D, Koenen B, Gruenert R, Silbernagl G, Vidojkovic S, Chen LM, Weidenthaler H, Samy N, Chaplin P

Abstract
BACKGROUND: Respiratory syncytial virus (RSV) is a major cause of severe respiratory disease in young children and the elderly. Protective immunity is not generated after repeated infections, but vaccination may hopefully prove effective.
METHODS: This phase 2 clinical study investigated a multivalent RSV vaccine (MVA-BN®-RSV) designed to induce broad antibody and cellular immune responses by encoding RSV surface proteins F, G (for both A and B subtypes), and internal antigens (M2, N). This study evaluated the immune response in adults ≥55 years to identify the optimal MVA-BN-RSV dose and vaccination schedule.
RESULTS: A single dose increased the levels of neutralizing (PRNT to RSV A and B) and total (IgG and IgA ELISA) antibodies (1.6 to 3.4-fold increase from baseline) and induced a broad Th1-biased cellular immune response (IFN-γ ELISPOT) to all 5 vaccine inserts (5.4 to 9.7-fold increases). Antibody responses remained above baseline for 6 months. A 12-month booster dose elicited a booster effect in antibody and T cell responses (up to 2.8-fold from pre-boost levels). No drug-related serious adverse events were reported.
CONCLUSIONS: MVA-BN-RSV induces a broad immune response that persists at least 6 months and can be boosted at 12 months, without significant safety findings.
CLINICAL TRIALS REGISTRATION: NCT02873286.

PMID: 32726422 [PubMed - as supplied by publisher]

Safety and effectiveness of a biosimilar biphasic insulin in the management of diabetes mellitus during routine clinical practice in Asian patients.

Med J Malaysia. 2020 07;75(4):372-378

Authors: Hussein Z, Aziz NA, Dhanaraj E, Brahmachari B, Kothekar M

Abstract
INTRODUCTION: Biosimilar insulins have the potential to increase access to treatment among patients with diabetes mellitus (DM), reduce treatment costs, and expand market competition. There are no published studies evaluating the performance of biosimilar insulins in routine clinical practice in Asia. This study assessed the safety and effectiveness of biphasic isophane insulin injection in Malaysian DM patients.
MATERIALS AND METHODS: In this open label, single-arm, observational, post marketing study, patients received biphasic isophane insulin injection as per the Prescribing Information; and were assessed for safety (adverse events including hypoglycaemia), effectiveness (glycosylated haemoglobin [HbA1c]; fasting blood sugar, [FBS]; and patient's condition by patient and physician) over a period of 24 weeks.
RESULTS: Adult male and female diabetes patients (N=119; type 2 DM, n=117) with a mean (SD) diabetes duration of 13 years were included. No new safety signals have been identified. Significant reduction in HbA1c was observed at weeks 12 and 24 (mean [SD] - baseline: 9.6% [1.9]; Week 12: 9.0% [1.7] and at Week 24: 9.1% [1.7]; p < 0.001). There were 10 serious and 9 non-serious adverse events reported in the study. Expected mild events included hypoglycaemia and injection site pruritus. However, the majority of the adverse events were non-study drug related events. No deaths were reported during the study.
DISCUSSION: Biphasic isophane insulin injection was well tolerated with no new safety concerns. It was found effective in post- marketing studies conducted in routine clinical settings when administered in DM patients in this study.

PMID: 32723997 [PubMed - as supplied by publisher]

Lay Pharmacovigilance and the Dramatization of Risk: Fluoroquinolone Harm on YouTube.

J Health Soc Behav. 2019 12;60(4):509-524

Authors: Barker KK

Abstract
Sociologists have documented how the pharmaceutical industry has corrupted pharmacovigilance (PV), defined as the practices devoted to detecting and preventing adverse drug reactions (ADRs). In this article, I juxtapose the official postmarketing system of PV with firsthand accounts of ADRs as found in 60 YouTube vlogs created by 29 individuals who recount debilitating reactions to fluoroquinolones, a common class of antibiotics. Whereas official PV is said to contribute the banalization of risk, these vlogs exemplify the dramatization of risk. I consider the vlogs as instances of lay PV. They represent lay knowledge claims created in response to perceived failures in the official system of regulation. As such, lay PV shares commonalties with other articulations of lay expertise as a counter to medical authority. At the same time, this case also underscores how the YouTube platform offers new tools for the creation and distribution of lay expertise.

PMID: 31771357 [PubMed - indexed for MEDLINE]

Current and new rotavirus vaccines.

Curr Opin Infect Dis. 2019 10;32(5):435-444

Authors: Burke RM, Tate JE, Kirkwood CD, Steele AD, Parashar UD

Abstract
PURPOSE OF REVIEW: As of 2019, four rotavirus vaccines have been prequalified by the WHO for use worldwide. This review highlights current knowledge regarding rotavirus vaccines available, and provides a brief summary of the rotavirus vaccine pipeline.
RECENT FINDINGS: Data generated from use of currently available products supports their effectiveness and impact in diverse settings. Rotavirus vaccines have a favorable risk-benefit profile, but previous associations of rotavirus vaccination with intussusception necessitate continued monitoring for this rare but serious adverse event. Implementation of rotavirus vaccines was jeopardized in late 2018 and 2019 by a shortage of vaccine supply. Fortunately, with the prequalification of two additional vaccines in 2018, countries have increased choice in products with different characteristics, pricing, and implementation strategies. Other vaccines currently in development may open up further immunization strategies, such as neonatal vaccination schedules or parenteral administration.
SUMMARY: Rotavirus vaccines have demonstrated impact in reducing diarrheal morbidity and mortality worldwide. As countries begin to introduce the newly prequalified vaccines, additional data will become available on the safety and effectiveness of those products. Products in the pipeline have distinct profiles and could be an essential part of the expansion of rotavirus vaccine use worldwide.

PMID: 31305493 [PubMed - indexed for MEDLINE]

Tafenoquine: the new kid on the block.

Curr Opin Infect Dis. 2019 10;32(5):407-412

Authors: Chen V, Daily JP

Abstract
PURPOSE OF REVIEW: This is a review of tafenoquine, a new antimalarial drug. Here we examine the recent literature supporting the use of tafenoquine and summarize the opportunities and challenges for its well tolerated use worldwide.
RECENT FINDINGS: Tafenoquine was recently approved by the US Food and Drug Administration for the treatment of dormant liver stage (hypnozoite) in Plasmodium vivax and for malaria prophylaxis. Single-dose tafenoquine provides equivalent efficacy to 14 days of primaquine for radical cure in P. vivax, and it can be dosed weekly to prevent malaria. However, tafenoquine can only be used in patients with normal G6PD activity and is contraindicated in children and during pregnancy or in lactating mothers with infants of deficient or unknown G6PD status.
SUMMARY: Tafenoquine's long half-life allows a single dose to achieve radical cure, and weekly dosing for chemoprophylaxis to provide an exciting therapeutic option for patient care and as a new weapon for malaria control/eradication programs. Global implementation of tafenoquine will require the development and validation of a robust, low-cost diagnostic to reliably identify G6PD-deficient individuals. In addition, studies on tafenoquine safety in children are needed.

PMID: 31305490 [PubMed - indexed for MEDLINE]

Treatment of relapsed and refractory multiple myeloma.

Blood Res. 2020 Jul 31;55(S1):S43-S53

Authors: Lee JH, Kim SH

Abstract
The therapeutic strategy for relapsed and refractory multiple myeloma (RRMM) integrates a holistic approach regarding patient, disease, and drug-related factors. Patient-related factors include age, frailty status, and underlying comorbidities, especially cardiovascular and renal diseases and peripheral neuropathies that affect tolerability to multiple drug combinations or transplantations. Disease-related factors encompass these multiple patient-related factors, particularly the aggressiveness of the disease and cytogenetics. Regarding drug-related factors, the approval of novel proteasome inhibitors (such as carfilzomib and ixazomib), immunomodulatory agents (such as pomalidomide), monoclonal antibodies (such as daratumumab and elotuzumab), and new classes of drugs increasingly makes the choice treatment more complex and necessitates a comprehensive summary and an update of the efficacy and toxicities of each antimyeloma drug and its combinations. Further, careful monitoring of the side effects and supportive care throughout the course of treatment are important to achieve better outcomes for patients with RRMM.

PMID: 32719176 [PubMed]

A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan.

Cancer Rep (Hoboken). 2019 Oct;2(5):e1179

Authors: Chiou TJ, Chao TC, Chao TY, Huang JS, Chang YF, Wang CH

Abstract
BACKGROUND: Fentanyl buccal soluble film (FBSF), a new formulation of fentanyl, is developed for the treatment of breakthrough pain (BTP) in opioid-tolerant patients with cancer.
AIMS: This study aimed to assess the feasible dose range of FBSF required for Taiwanese population.
METHODS AND RESULTS: This was an open-label, multicenter, noncomparative study. Cancer patients who were aged 20 years or older and had a stable regimen equivalent to 60 to 1000 mg/day of oral morphine, 20 to 120 mg/day of intravenous morphine, or 25 to 300 μg/h of transdermal fentanyl for at least 1 week were enrolled. The primary endpoint was the feasible dose range of FBSF. Secondary endpoints included difference in pain intensity at 30 minutes (PID30), percentage of episodes requiring rescue medication, and overall satisfaction. Adverse events (AEs) and serious AEs (SAEs) were recorded for safety measurements. The final effective dose in the per-protocol (PP) population (n = 30) ranged from 200 to 800 μg, of which 26 subjects (86.7%) achieved an effective dose range of 200 to 400 μg. Among the 283 BTP episodes recorded in the maintenance period, the mean PID30 was 4.0, and only 13 events (4.6%) required rescue medication. For 63.6% of the BTP episodes, patients rated their satisfaction as good to excellent. Only 5% of AEs were considered drug-related.
CONCLUSIONS: Individualized dose titration is recommended for BTP management for patients' benefit. Overall, FBSF was effective and well tolerated and was positively correlated with patients' background opioid dose for persistent pain management.

PMID: 32721110 [PubMed - as supplied by publisher]

The cardiovascular health of prisoners who use cannabis: An exploratory study among hospitalised prisoners.

Therapie. 2020 Jul 09;:

Authors: Mongiatti M, Bayle P, Lagarrigue A, Fabre D, Telmon N, Lapeyre-Mestre M, Jouanjus E

Abstract
OBJECTIVE: It is essential that health professionals who practice medicine in prison rely on accurate knowledge about their patients to provide them with adapted care. The use of cannabis can influence the health status of prisoners, but data are lacking regarding the potentially related adverse health consequences. The objective of this descriptive study was to describe the cardiovascular outcomes related to cannabis use in prisoners from several detention centres hospitalised in a French hospital.
METHODS: In France, prisoners who require a longer than 48-hour hospitalisation are admitted in specific secured polyvalent units called inter-regional secured hospital units (ISHU). Hospitalisations in the ISHU of Toulouse University Hospital between 2012 and 2016 for cardiovascular disorders potentially related to the use of cannabis were extracted from the French hospital database and analysed using a previously validated methodology. Included patients were those hospitalised for an inaugural cardiovascular event or deterioration of a preexisting cardiovascular illness who declared having used cannabis while imprisoned.
RESULTS: Overall, 31 cardiovascular outcomes were identified in cannabis-using hospitalised prisoners among 411 hospitalisations for cardiovascular disorders (all men, mean age 43±SD years old). All used cannabis (daily: 56%) and tobacco (more than 15 PY: 83.3%), 5 used cocaine, and none used alcohol. The most frequent were coronaropathy (n=13), followed by obliterating arteriopathy of the lower limb (OALL, n=7), arrhythmic cardiomyopathy (n=4), venous thrombosis (n=3), infectious cardiopathy (n=2), and ischemic stroke (n=2).
CONCLUSION: This description of serious cardiovascular outcomes in prisoners who use cannabis provides insights into the clinical features possibly observed in this vulnerable population The findings indicate that 7.5% of hospitalizations of prisoners for cardiovascular disorders are potentially linked to cannabis used in prison.

PMID: 32718583 [PubMed - as supplied by publisher]

Anti-PD-1-Related Exacerbation of Interstitial Lung Disease in a Patient with Non-Small Cell Lung Cancer: A Case Presentation and Review of the Literature.

Cancer Invest. 2020 Jul;38(6):365-371

Authors: L Gemmill JA, Sher A

Abstract
Immunotherapy is standard first-line therapy for advanced non-small cell lung cancer (NSCLC) either alone or in combination with chemotherapy. Despite significant benefits, immune checkpoint inhibitors (ICI) can cause toxicities within any organ, termed immune related adverse events. Pneumonitis is a potentially life-threatening complication of ICIs. Currently, there are no established guidelines for use of ICIs in patients with underlying autoimmune or interstitial lung disease (ILD) and few studies have been published. We present a case of first-line ICI-chemotherapy in a patient with metastatic NSCLC and ILD who suffered treatment related lung toxicity and acute worsening ILD, which lead to his death.

PMID: 32559143 [PubMed - indexed for MEDLINE]

Pharmacovigilance 2030: Invited Commentary for the January 2020 "Futures" Edition of Clinical Pharmacology and Therapeutics.

Clin Pharmacol Ther. 2020 01;107(1):89-91

Authors: Arlett P, Straus S, Rasi G

PMID: 31758540 [PubMed - indexed for MEDLINE]

The utility of a telemedicine platform to monitor adherence and adverse effects of tyrosine kinase inhibitors.

Leuk Lymphoma. 2019 07;60(7):1842-1844

Authors: Copeland AC, Foster MC, Muluneh B, Xenakis JG, Ivanova A, Frankfurt O, Clayton M, Black A, Rapchak B, Wehbie RS

PMID: 30773105 [PubMed - indexed for MEDLINE]