Severe adverse drug reactions to biological disease-modifying anti-rheumatic drugs in elderly patients with rheumatoid arthritis in clinical practice.

Clin Exp Rheumatol. 2018 Jan-Feb;36(1):29-35

Authors: Leon L, Gomez A, Vadillo C, Pato E, Rodriguez-Rodriguez L, Jover JA, Abasolo L

Abstract
OBJECTIVES: Biological DMARDs are widely used in the treatment of rheumatoid arthritis (RA) but their relationship with adverse drug reaction (ADR) is important. RA is now known to increase in incidence and prevalence with age. Our objective was to assess the incidence of severe ADR in the long term, compare safety between the different bDMARDs and identify other possible risk factors for severe ADR in elderly RA patients.
METHODS: A 14-year retrospective longitudinal study was performed. RA patients followed in an out-patient clinic starting bDMARDs after the age of 65 were included.
PRIMARY OUTCOME: discontinuation due to a severe ADR related to bDMARDs (etanercept, infliximab, adalimumab, rituximab, golimumab, certolizumab, abatacept and tocilizumab). Covariables: sociodemographic, clinical and therapy. Incidence rates of discontinuation were estimated using survival techniques and comparison between bDMARDs discontinuation rates and other associated factors were run by Cox regression models.
RESULTS: We analysed 286 courses of bDMARDs therapy in 146 elderly patients (604 patient-years). 78% were women, with a mean age at diagnosis of 66.5±7 years, and a median time to the start of the first bDMARDs of 6±4 years. The incidence of discontinuation due to severe ADR estimated was 10.2% patient-years, with a median survival of around 7 years. The most frequent cause was infections. Etanercept had the lowest risk of severe ADR compared to other bDMARDs.
CONCLUSIONS: Our study reflects the 'real world' experience in elderly RA patients on bDMARDs, with non-selected patients for a 14-year follow-up.

PMID: 28598787 [PubMed - indexed for MEDLINE]

Prolonged Pemetrexed Infusion Plus Gemcitabine in Refractory Metastatic Colorectal Cancer: Preclinical Rationale and Phase II Study Results.

Oncologist. 2017 Aug;22(8):886-e79

Authors: Passardi A, Fanini F, Turci L, Foca F, Rosetti P, Ruscelli S, Casadei Gardini A, Valgiusti M, Dazzi C, Marangolo M

Abstract
LESSONS LEARNED: Difficulties in translating in vitro results into clinical practice are inevitable.Further efforts to verify the efficacy of alternative schedules of pemetrexed in solid tumors are encouraged.
BACKGROUND: We investigated the cytotoxic activity of pemetrexed in combination with several drugs (gemcitabine, carboplatin, vinorelbine, and mitomycin C) using different exposure schedules in three colon cancer cell lines. The best results were obtained with the following schedule: a prolonged pemetrexed exposure followed by a 48-hour wash-out and then gemcitabine. This combination was then advanced to a phase II clinical trial.
METHODS: Patients with metastatic colorectal cancer in progression after standard treatment were included in the study. Adequate bone marrow reserve, normal hepatic and renal function, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 were required. Treatment consisted of an 8-hour intravenous infusion of pemetrexed 150 mg/m2 on day 1 and a 30-minute intravenous infusion of gemcitabine 1,000 mg/m2 on day 3 of each cycle, repeated every 14 days.
RESULTS: Fourteen patients were enrolled onto the study (first step). No objective responses were seen, and evidence of stable disease was observed in only one of the 12 evaluable patients. The most important grade 3-4 side effects were hematological toxicity (neutropenia 64.2%, thrombocytopenia 71.4%, anemia 28.7%), fatigue (50.0%), and stomatitis (21.5%). Median overall survival and time to progression were 5.8 months (95% confidence interval [CI]: 3.9-7.1) and 2.1 months (95% CI: 1.7-2.8), respectively.
CONCLUSION: The experimental pemetrexed-gemcitabine combination proved to be inactive and moderately toxic.

PMID: 28592624 [PubMed - indexed for MEDLINE]

Patient Understanding of the Risks and Benefits of Biologic Therapies in Inflammatory Bowel Disease: Insights from a Large-scale Analysis of Social Media Platforms.

Inflamm Bowel Dis. 2017 Jul;23(7):1057-1064

Authors: Martinez B, Dailey F, Almario CV, Keller MS, Desai M, Dupuy T, Mosadeghi S, Whitman C, Lasch K, Ursos L, Spiegel BMR

Abstract
BACKGROUND: Few studies have examined inflammatory bowel disease (IBD) patients' knowledge and understanding of biologic therapies outside traditional surveys. Here, we used social media data to examine IBD patients' understanding of the risks and benefits associated with biologic therapies and how this affects decision-making.
METHODS: We collected posts from Twitter and e-forum discussions from >3000 social media sites posted between June 27, 2012 and June 27, 2015. Guided by natural language processing, we identified posts with specific IBD keywords that discussed the risks and/or benefits of biologics. We then manually coded the resulting posts and performed qualitative analysis using ATLAS.ti software. A hierarchical coding structure was developed based on the keyword list and relevant themes were identified through manual coding.
RESULTS: We examined 1598 IBD-related posts, of which 452 (28.3%) centered on the risks and/or benefits of biologics. There were 5 main themes: negative experiences and concerns with biologics (n = 247; 54.6%), decision-making surrounding biologic use (n = 169; 37.4%), positive experiences with biologics (n = 168; 37.2%), information seeking from peers (n = 125; 27.7%), and cost (n = 38; 8.4%). Posts describing negative experiences primarily commented on side effects from biologics, concerns about potential side effects and increased cancer risk, and pregnancy safety concerns. Posts on decision-making focused on nonbiologic treatment options, hesitation to initiate biologics, and concerns about changing or discontinuing regimens.
CONCLUSIONS: Social media reveals a wide range of themes governing patients' experience and choice with IBD biologics. The complexity of navigating their risk-benefit profiles suggests merit in creating online tailored decision tools to support IBD patients' decision-making with biologic therapies.

PMID: 28410343 [PubMed - indexed for MEDLINE]

Preferences for 'New' Treatments Diminish in the Face of Ambiguity.

Health Econ. 2017 Jun;26(6):743-752

Authors: Harrison M, Marra CA, Bansback N

Abstract
New products usually offer advantages over existing products, but in health care, most new drugs are 'me-too', comparable in effectiveness and side effects to existing drugs, but with a more ambiguous evidence base around adverse effects. Despite this, new treatments drive increased health care spending, suggesting a preference for 'newness' in this setting. We explore (1) whether preferences for treatments labeled 'new' exist and (2) persist once the ambiguity in the evidence base reflecting newness is described. We use a Canadian general population sample (n = 2837) characterized by their innovativeness in adopting new products in normal markets. We found that innovators/early adopters (n = 173) had significant preferences for 'newer' treatments (B = 0.162, p = 0.038) irrespective of comparable benefits and side effects and all respondents had significant preferences for less ambiguity in benefit/side effect estimates. Notably, when 'newness' was combined with ambiguity, no significant preferences for new treatments were observed regardless of respondent innovativeness. We conclude that preferences for new products exist for some people in health care markets but disappear when the implication of ambiguity in the evidence base for new treatments is communicated. Physicians should avoid describing treatments as 'new' or be mindful to qualify the implications of 'new' treatments in terms of evidence ambiguity. Copyright © 2016 John Wiley & Sons, Ltd.

PMID: 27174417 [PubMed - indexed for MEDLINE]

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Establishment of a drug-induced rhabdomyolysis mouse model by co-administration of ciprofloxacin and atorvastatin.

Toxicol Lett. 2018 Apr 18;:

Authors: Matsubara A, Oda S, Akai S, Tsuneyama K, Yokoi T

Abstract
Rhabdomyolysis is one of the serious side effects of ciprofloxacin (CPFX), a widely used antibacterial drug; and occasionally, acute kidney injury (AKI) occurs. Often, rhabdomyolysis has occurred in patients taking CPFX co-administered with statins. The purpose of this study is to establish a mouse model of drug-induced rhabdomyolysis by co-administration of CPFX and atorvastatin (ATV) and to clarify the mechanisms of its pathogenesis. C57BL/6J mice treated with L-buthionine-(S,R)-sulfoximine (BSO), a glutathione synthesis inhibitor, were orally administered with CPFX and ATV for 4 days. Plasma levels of creatinine phosphokinase (CPK) and aspartate aminotransferase (AST) were significantly increased in the CPFX and ATV-co-administered group. Histopathological examination of skeletal muscle observed degeneration in gastrocnemius muscle and an increased number of the satellite cells. Expressions of skeletal muscle-specific microRNA and mRNA in plasma and skeletal muscle, respectively, were significantly increased. The area under the curve (AUC) of plasma CPFX was significantly increased in the CPFX and ATV-co-administered group. Furthermore, cytoplasmic vacuolization and a positively myoglobin-stained region in kidney tissue and high content of myoglobin in urine were observed. These results indicated that AKI was induced by myoglobin that leaked from skeletal muscle. The established mouse model in the present study would be useful for predicting potential rhabdomyolysis risks in preclinical drug development.

PMID: 29679711 [PubMed - as supplied by publisher]

Hematologic Adverse Events Associated with Prolonged Valganciclovir Treatment in Congenital Cytomegalovirus Infection.

Pediatr Infect Dis J. 2018 Apr 19;:

Authors: Ziv L, Yacobovich J, Pardo J, Yarden-Bilavsky H, Amir J, Osovsky M, Bilavsky E

Abstract
BACKGROUND: Valganciclovir (2/d) therapy for 6 months in neonates with symptomatic congenital cytomegalovirus infection improves hearing and neurodevelopmental outcome. The only reported adverse event was neutropenia. Since 2009, our protocol for symptomatic congenital cytomegalovirus infection was a 1-year treatment of 2/d for the first 3 months followed by 9 months of 1/d.
METHODS: A retrospective study. Infants with congenital cytomegalovirus treated with valganciclovir for 1 year were recruited. Data of drug-related hematologic adverse events were collected.
RESULTS: 160 infants were eligible; 46 (28.8%) had experienced at least 1 episode of neutropenia (58 episodes), the majority (39/46, 84.8%) during the first 3 months of treatment and 7 (15.2%) during the last 9 months of treatment. Grades 3 and 4 neutropenia occurred in 9 (5.6%) children, almost exclusively during the first 3 months of treatment. Anemia (hemoglobin <9 g/dL) was recorded in 12 (7.5%) children, during the first 3 months of 2/d treatment. Four children presented with hemoglobin levels <7 g/dL and needed a blood transfusion. One child was diagnosed with transient pure red cell aplasia. No long-term adverse events were recorded.
CONCLUSIONS: While prolonged valganciclovir treatment for congenital cytomegalovirus is safe, a close monitoring of the white blood cell count and hemoglobin levels is warranted. Much lower rates of grades 3 and 4 neutropenia were observed than previously reported, probably owing to our unique treatment protocol. Nevertheless, drug-induced anemia should be of primary concern. The optimal protocol assessing clinical outcome, concurrently with potential side effects, has as yet not been determined.

PMID: 29677086 [PubMed - as supplied by publisher]

PRO 140, a monoclonal antibody targeting CCR5, as a long-acting, single-agent maintenance therapy for HIV-1 infection.

HIV Clin Trials. 2018 Apr 20;:1-9

Authors: Dhody K, Pourhassan N, Kazempour K, Green D, Badri S, Mekonnen H, Maddon PJ, Burger D

Abstract
Background PRO 140 is a humanized monoclonal antibody targeting CCR5 with potent antiviral activity in patients with CCR5-tropic HIV-1 infection. In phase 2b studies, we evaluated the long-term efficacy, safety, and tolerability of PRO 140 monotherapy in maintaining viral suppression for over 24 months in patients who were stable on combination antiretroviral therapy on entry into the trials. Methods and Results Forty-one adult patients, infected exclusively with CCR5-tropic HIV-1 with viral loads <50 copies/mL, were switched from daily oral combination ART regimens to weekly PRO 140 monotherapy for 12 weeks. Participants who completed 12 weeks of treatment without experiencing virologic rebound were allowed to self-administer PRO 140 as a 350 mg subcutaneous injection weekly, for up to an additional 160 weeks. Participants were monitored bi-weekly for one year, and every four weeks thereafter for virologic rebound. PRO 140 provided virologic suppression in 23/41 (56.1%) participants for 12 weeks and was well tolerated. Ten (10) participants are currently ongoing, of which nine participants have completed more than two years of monotherapy treatment (47-129 weeks). Participants experiencing virologic rebound achieved full viral suppression upon re-initiation of oral combination ART regimen. Anti-PRO 140 antibodies were not detected in any patient, and no drug-related major adverse events or treatment discontinuations were reported. Conclusions PRO 140 has a potential to address an unmet need for a long-acting, single-agent, maintenance regimen for HIV infection in selected patients. Studies are underway to determine host and/or virologic factors that may predict treatment success on PRO 140 monotherapy. Moreover, it has sufficient potency for a prolonged period of monotherapy that it would be an excellent component of a multi long-acting drug combination.

PMID: 29676212 [PubMed - as supplied by publisher]

KALIS - An eHealth System for Biomedical Risk Analysis of Drugs.

Stud Health Technol Inform. 2017;236:128-135

Authors: Shoshi A, Müller U, Shoshi A, Ogultarhan V, Hofestädt R

Abstract
BACKGROUND: In Germany, adverse drug reactions and events cause hospitalizations, which lead to numerous thousands of deaths and several million Euros in additional health costs annually.
OBJECTIVES: Approximately one in two deaths could be avoided by an appropriate system for risk analysis of drugs.
METHODS: The integration and storage of several data sources from life sciences are an ongoing need to address various questions with respect to drug therapy. A software architecture for data integration was implemented in order to build up a new data warehouse named KALIS-DWH, which includes pharmacological, biomolecular and patient-related data.
RESULTS: Based on this comprehensive KALIS-DWH, an eHealth system named KALIS for biomedical risk analysis of drugs was implemented. The task-specific modules of KALIS offer efficient algorithms for analyzing medication and supporting decision-making in drug therapy.
CONCLUSION: KALIS is meant to be a web-based information system for health professionals and researchers. KALIS provides comprehensive knowledge and modules for risk analysis of drugs, which can contribute to minimizing prescribing errors.

PMID: 28508788 [PubMed - indexed for MEDLINE]

More than 25 years of genetic studies of clozapine-induced agranulocytosis.

Pharmacogenomics J. 2017 Jul;17(4):304-311

Authors: de With SAJ, Pulit SL, Staal WG, Kahn RS, Ophoff RA

Abstract
Clozapine is one of the most effective atypical antipsychotic drugs prescribed to patients with treatment-resistant schizophrenia. Approximately 1% of patients experience potential life-threatening adverse effects in the form of agranulocytosis, greatly hindering its applicability in clinical practice. The etiology of clozapine-induced agranulocytosis (CIA) remains unclear, but is thought to be a heritable trait. We reviewed the genetic studies of CIA published thus far. One recurrent finding from early candidate gene study to more recent genome-wide analysis is that of the involvement of human leukocyte antigen locus. We conclude that CIA is most likely a complex, polygenic trait, which may hamper efforts to the development of a genetic predictor test with clinical relevance. To decipher the genetic architecture of CIA, it is necessary to apply more rigorous standards of phenotyping and study much larger sample sizes.

PMID: 28418011 [PubMed - indexed for MEDLINE]

Association Between Psychotropic and Cardiovascular Iatrogenic Alerts and Risk of Hospitalizations in Elderly People Treated for Dementia: A Self-Controlled Case Series Study Based on the Matching of 2 French Health Insurance Databases.

J Am Med Dir Assoc. 2017 Jun 01;18(6):549.e1-549.e13

Authors: Zerah L, Boddaert J, Leperre-Desplanques A, Bonnet-Zamponi D, Verny M, Deligne J, Boelle PY

Abstract
BACKGROUND: Elderly people are at risk of repeated hospitalizations, some of which may be drug related and preventable. In 2011, a group of French healthcare experts selected 5 iatrogenic alerts (IAs), based on criteria identified in a literature search and from their professional experience, to assess the appropriateness of medication in elderly patients.
OBJECTIVES: Our objective was to examine the association between hospitalizations and IAs in elderly patients treated for Alzheimer disease who are particularly sensitive to adverse drug events.
DESIGN: A 2-year (January 1, 2011, to December 31, 2012) longitudinal national database study, with a study design similar to self-controlled case series, was performed to analyze data on drug prescriptions and hospitalization. IAs were defined as (1) long half-life benzodiazepine; (2) antipsychotic drugs in patients with Alzheimer disease; (3) co-prescription of 3 or more psychotropic drugs; (4) co-prescription of 2 or more diuretics; and (5) co-prescription of 4 or more antihypertensive drugs. Data were obtained by matching of 2 French National Health Insurance Databases.
SETTING: France.
PARTICIPANTS: All affiliates, aged ≥75 years, receiving treatment for Alzheimer disease, alive on January 1, 2011 were included.
MEASUREMENTS: We calculated the relative increase in the number of hospitalizations in patients with IAs. The analysis was performed over four 6-month periods.
RESULTS: A total of 10,754 patients were included. During the periods with IAs, hospitalization rates increased by 0.36/year compared with 0.23/year in the periods without for the same patient, and the number of hospitalizations doubled [proportional fold change = 1.9, 95% confidence interval (1.8, 2.1)]. We estimated that 22% [95% confidence interval (20%, 23%)] of all hospitalizations were associated with IAs, 80% of which were due to psychotropic IAs.
CONCLUSIONS: The IAs could be used as a simple and clinically relevant tool by prescribing physicians to assess the appropriateness of the prescription in elderly patients treated for Alzheimer disease.

PMID: 28330633 [PubMed - indexed for MEDLINE]

Gemcitabine as second-line chemotherapy after Folfirinox failure in advanced pancreatic adenocarcinoma: A retrospective study.

Dig Liver Dis. 2017 Jun;49(6):692-696

Authors: Viaud J, Brac C, Artru P, Le Pabic E, Leconte B, Bodère A, Pracht M, Le Sourd S, Edeline J, Lièvre A

Abstract
BACKGROUND: Pancreatic adenocarcinoma (PA) is diagnosed in most cases at an advanced stage requiring chemotherapy. Folfirinox is the standard first-line treatment. After Folfirinox failure, gemcitabine alone is routinely used as second-line therapy without data supporting this attitude.
AIM: Determine the response rate and outcome of patients with advanced PA treated with gemcitabine after Folfirinox failure.
METHODS: We retrospectively analyzed all consecutive patients treated with gemcitabine after Folfirinox failure for a locally advanced or metastatic PA between 2009 and 2015. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Response rate, control rate and tolerability were assessed.
RESULTS: 96 patients were included (male, 51%; median age, 62; performance status (PS) 0-1, 47%). Median duration on gemcitabine was 2.1 months. The overall disease control rate was 40%. Median OS was 3.7 months (95%CI: 2.5-5.2) and median PFS was 2.1 months (95%CI: 2.0-2.6). Reasons for treatment discontinuation were mostly progression (51%). Age at diagnosis and PS were independently associated with OS in multivariate analysis (HR of 1.86; p=0.0055 and 2.42; p<0.0001 respectively). 34 patients experienced a grade 3 adverse event.
CONCLUSIONS: This study suggests that gemcitabine is not beneficial to all patients failing on Folfirinox first-line therapy and should be restricted to young patients with good PS.

PMID: 28256401 [PubMed - indexed for MEDLINE]

Comprehensive Literature Review of Factors Influencing Medication Safety in Nursing Homes: Using a Systems Model.

J Am Med Dir Assoc. 2017 Jun 01;18(6):470-488

Authors: Al-Jumaili AA, Doucette WR

Abstract
OBJECTIVES: The objectives of this review were to identify the work system factors influencing medication safety measures [adverse drug events (ADEs), adverse drug reactions, or medication errors (MEs)], to determine the incidence of ADEs, and describe the most common ADEs in nursing homes (NHs).
METHODS: A comprehensive literature review was conducted using PubMed and CINAHL to identify studies investigating factors that influence ADEs, adverse drug reactions, and MEs in NHs and skilled nursing facilities. An initial search identified related studies over 3 decades (1985-2016). Studies were classified according to Systems Engineering Initiative for Patient Safety model factors.
RESULTS: Sixty studies were included in this review, which identifies 5 categories of work system factors affecting medication safety in NHs: persons (resident and staff), organization, tools and technology, tasks, and environment. The personal characteristics of NH residents included age, number and types of scheduled medications, and number and types of comorbidities. In addition, inadequate nursing staff medication knowledge and training are usually associated with administration MEs. Organizational factors include interprofessional collaboration, physician and pharmacist accessibility, and staff/resident ratio. A high staff number plays an essential role in preventing MEs and fracture incidents. The technology (barcode medication system) and tools (ME-reporting systems, ADE trigger tool, and potentially inappropriate medication criteria) can enhance the detection of MEs and ADEs. Workload and time pressure negatively impact NH staff task performance. Use of an ADE trigger tool by healthcare providers enhanced the ability to identify ADEs more than 50-fold over 6 months. Several environmental characteristics such as staff distraction and interruption negatively influence medication safety in NHs. The incidence rates of ADEs in NHs ranged from 1.89 to 10.8 per 100 resident-months. The most common ADEs were bleeding, thromboembolic events, hypoglycemia, falls, and constipation.
CONCLUSIONS: The Systems Engineering Initiative for Patient Safety model is a useful framework for investigating the factors contributing to ADEs. Multiple work-system factors affect the medication safety of NH residents. A comprehensive study is needed to quantify the influence of various work-system factors on ADEs in NHs.

PMID: 28242191 [PubMed - indexed for MEDLINE]

Review of targeted therapy in chronic lymphocytic leukemia: what a radiologist needs to know about CT interpretation.

Cancer Imaging. 2018 Apr 18;18(1):13

Authors: Gosangi B, Davids M, Somarouthu B, Alessandrino F, Giardino A, Ramaiya N, Krajewski K

Abstract
The last 5 years have been marked by profound innovation in the targeted treatment of chronic lymphocytic leukemia (CLL) and indolent lymphomas. Using CLL as a case study, we present a timeline and overview of the current treatment landscape for the radiologist, including an overview of clinical and radiological features of CLL, discussion of the targeted agents themselves, and the role of imaging in response and toxicity assessment. The goal is to familiarize the radiologist with multiple Food and Drug Administration (FDA)-approved targeted agents used in this setting and associated adverse events which are commonly observed in this patient population.

PMID: 29669600 [PubMed - in process]

Patients with platelet aggregation inhibitors in the dental office

Swiss Dent J. 2018 Apr 15;128(4):317-319

Authors: Yildirim A, Lübbers HT, Yildirim A

Abstract
Antiplatelet agents with the active ingredients acetylsalicylic acid (Aspirin® protect 100), clopidogrel (Iscover®, Plavix®), prasugrel (Efient®) or ticagrelor (Brilique™) prevent the clumping of platelets and thus the formation of small clots at constrictions of the coronary arteries or on the metal struts of stents in the coronary artery or in bypass grafts. Large-scale studies have shown that taken regularly, these drugs can extend life and help prevent heart attacks. Especially in patients with newly implanted stents, the combination of the above-mentioned agents prevents sudden complete occlusion of the vessel concerned. By paying careful attention to contraindications and pursuing the early detection of possible side effects, drug-induced complications can be prevented.

PMID: 29669404 [PubMed - in process]

Unexpected exacerbations following initiation of disease-modifying drugs in neuromyelitis optica spectrum disorder: Which factor is responsible, anti-aquaporin 4 antibodies, B cells, Th1 cells, Th2 cells, Th17 cells, or others?

Mult Scler. 2017 Aug;23(9):1300-1302

Authors: Kira JI

Abstract
Some disease-modifying drugs for multiple sclerosis, which mainly act on T cells, are ineffective for neuromyelitis optica spectrum disorder and induce unexpected relapses. These include interferon beta, glatiramer acetate, fingolimod, natalizumab, and alemtuzumab. The cases reported here suggest that dimethyl fumarate, which reduces the number of Th1 and Th17 cells and induces IL-4-producing Th2 cells, is also unsuitable for neuromyelitis optica spectrum disorder, irrespective of anti-aquaporin 4 IgG serostatus. Although oral dimethyl fumarate with manageable adverse effects is easy to initiate in the early course of multiple sclerosis, special attention should be paid for atypical demyelinating cases.

PMID: 28391741 [PubMed - indexed for MEDLINE]

Knowledge and characteristics of herbal supplement usage among community pharmacy customers in a Malaysian population.

Complement Ther Med. 2017 Dec;35:92-108

Authors: Yeong SW, Choong YC

Abstract
OBJECTIVES: We investigated the knowledge and characteristics of herbal supplement usage of the customers of community pharmacies in a Malaysian population.
DESIGN AND SETTING: Self-administered questionnaires (in English, Malay, or Chinese) were provided to customers at three community pharmacies in Malaysia (Ipoh, Perak). Questionnaire validation and translation validation were performed. A pilot study was conducted before actual questionnaire distribution. Informed consent was obtained from all participants.
RESULTS: Total number of participants was 270 (99 males and 171 females) with majority from the 31-50 age group (41.5%). Among the participants, 45.6% were herbal users. The most commonly used herbal supplements were evening primrose oil (17.9%), ginkgo biloba (13.0%), and milk thistle (8.5%). The participants seemed to have sufficient knowledge regarding herbal supplements including safety, quality, and indication of use from medical literature. Participants obtained information about herbal supplements from pharmacists (26.9%), package inserts (25.2%), friends (20.5%), and the Internet (13.3%) more often than from their doctors (9.8%). Most herbal users did not inform their doctors about their usage of herbal supplements (68.3%) or the side effects (61.5%). Herbal supplement users also tended to be women, >50-year-old, and those with higher monthly household incomes.
CONCLUSIONS: Community pharmacists have a vital role in educating their customers about the safe use of herbal supplements. The participants had sufficient knowledge about herbal supplement usage; therefore, customers of these community pharmacies may have benefitted from the advice of the pharmacists. Further studies could be carried out in future on the knowledge, skills and roles of community pharmacists in the safe use of herbal supplements.

PMID: 29154074 [PubMed - indexed for MEDLINE]

Allergy-like immediate reactions with herbal medicines in children: A retrospective study using data from VigiBase®.

Pediatr Allergy Immunol. 2017 Nov;28(7):668-674

Authors: Meincke R, Pokladnikova J, Straznicka J, Meyboom RHB, Niedrig D, Russmann S, Jahodar L

Abstract
BACKGROUND: The use of herbal medicines in children and the general population is continually on the rise with an overall herbal lifetime and current use ranging between 0.8%-85.5% and 2.2%-8.9%, respectively. Although acute hypersensitivity reactions are generally considered to be rare, little knowledge exists on the frequency and type of these reactions especially in specific populations like children.
OBJECTIVES: To assess the patterns of acute hypersensitivity reactions to herbal medicines reported to the WHO global individual case safety report (ICSR) database VigiBase® in children.
STUDY DESIGN: From the original VigiBase® extract for the time between 1968 and 2014, we included all reports with adverse drug reactions (ADR) associated with herbal medicines in children where WHO-ART reaction terms were indicative of acute hypersensitivity reactions.
RESULTS: VigiBase® contained 2646 ICSRs with 14 860 distinct adverse reactions reported in association with herbal medicine in children. Among those, 79 cases with 107 allergy-like reactions met our inclusion criteria. The most commonly reported WHO-ART terms were urticaria or rash/rash erythematous (59.8%), and allergic reaction (8.4%). The most frequently reported suspected herbal medicines were mixed herbal products (51.4%), Hedera helix (15.0%), and Echinacea purpurea (5.6%). Most frequent routes of administration were oral (75.9%), topical (8.9%), and rectal (3.8%). Over 30% of cases were reported in the age group from 7 to 12 years. The majority of reports were received from Germany (29.1%), Thailand (21.5%), and Australia (11.4%).
CONCLUSION: VigiBase® contains a considerable number of acute hypersensitivity reactions in children associated with herbal medicines, including life-threatening reactions such as anaphylactic shock.

PMID: 28846157 [PubMed - indexed for MEDLINE]

Acute kidney injury during treatment with high-dose cloxacillin: A report of 23 cases and literature review.

Int J Antimicrob Agents. 2018 Apr 14;:

Authors: Lavergne A, Vigneau C, Polard E, Triquet L, Rioux-Leclercq N, Tattevin P, Golbin L

Abstract
BACKGROUND: International guidelines recommend high-dose cloxacillin for endocarditis or osteoarticular infections due to meticillin-susceptible staphylococci. However, data on the tolerability of these regimens are scarce.
METHODS: We used the computerized registry of suspected drug-related adverse events in our institution. Cases of acute kidney injury (AKI), as defined by KDIGO, in patients receiving high-dose cloxacillin, were retrospectively reviewed. Data were collected from medical charts on a standardized questionnaire.
RESULTS: From 2009 to 2015, 23 consecutive patients (16 men, 7 women), with a median age of 75 years (interquartile range, IQR 66-80), fulfilled inclusion criteria. By the time of AKI diagnosis, patients were treated with a median cloxacillin dose of 12 g/day (IQR, 10-12), after a median duration of 7 days (IQR, 4-10). Most patients fulfilled RIFLE criteria for failure (n=20), with a median peak serum creatinine concentration of 339 µmol/L (IQR, 249-503). Urinalysis was suggestive of tubular disease in 7 patients, 3 had hypereosinophilia, and 8 had abnormal liver function tests. All patients presented at least one risk factor for AKI, including concomitant nephrotoxic drugs: gentamicin (n=19), diuretics (n=15), angiotensin-converting enzyme inhibitors (n=8), and angiotensin II receptor-blockers (n=6). Thirteen patients (57%) had cloxacilllin plasma concentrations >50 µg/mL. Thirteen patients (57%) had complete recovery of renal function.
CONCLUSIONS: AKI during high-dose cloxacillin treatment mostly occurs in elderly patients, with concomitant nephrotoxic drugs. The outcome is usually favorable after cloxacillin discontinuation. Therapeutic drug monitoring may decrease the risk of AKI in patients treated with high-dose cloxacillin.

PMID: 29665445 [PubMed - as supplied by publisher]

Introduction to Nephropharmacology for the Clinician: A New CJASN Series.

Clin J Am Soc Nephrol. 2018 Apr 16;:

Authors: Nolin TD, Perazella MA

PMID: 29661769 [PubMed - as supplied by publisher]