Drug-induced Adverse Events

Adverse events of fluoroquinolones vs. other antimicrobials prescribed in primary care: A systematic review and meta-analysis of randomized controlled trials.

Sat, 2018-04-28 07:27
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Adverse events of fluoroquinolones vs. other antimicrobials prescribed in primary care: A systematic review and meta-analysis of randomized controlled trials.

Int J Antimicrob Agents. 2018 Apr 24;:

Authors: Tandan M, Cormican M, Vellinga A

Abstract
BACKGROUND: Fluoroquinolones (FQs) are second line antimicrobial agents. Once the decision to prescribe an antimicrobial is made, its choice should be based on both the benefits and harms. This systematic review quantifies the occurrence of common adverse events (AEs) related to FQs in relation to any other antimicrobial for any indication in primary care.
METHODS: We searched randomized controlled trials from Embase, PubMed, Cochrane Central Register of Controlled Trials and CINHAL. FQs had to be administered orally, for any indication, to adults and in primary care. Data were extracted independently in standard forms in "Covidence". Pooled estimates of the intervention effects for AEs were determined by the Peto odds ratios (ORs) and 95% confidence intervals in Revman.
RESULTS: Of the 39 studies selected, the most commonly reported AEs were nausea, vomiting, diarrhoea, headache, dizziness, and rash. A meta-analysis of 28 studies reporting AEs showed central nervous system (CNS) (OR 1.40 (1.12-1.75) p=0.003, heterogeneity (I2) = 0%) and gastrointestinal (GI) related AEs (OR 1.20 (1.06-1.36) p=0.005, I2=80%) were significantly associated with FQs use compared to other antimicrobials. Compared to FQs, co-amoxiclav showed significantly more total AEs (OR 0.70 (0.54-0.90) p=0.006, I2=78%) and GI-related AEs (OR 0.69(0.52-0.91) p=0.008, I2=94%). Withdrawal and/or discontinuation due to drug-related AEs were higher for FQs (OR 1.19 (1.00-1.42) p=0.05, I2=5%). Sensitivity analyses did not change these results.
CONCLUSION: FQs are associated with more CNS and GI-related AEs compared to other types of antimicrobial. This information is relevant to support decision making in relation to antimicrobial prescribing.

PMID: 29702230 [PubMed - as supplied by publisher]

Categories: Literature Watch

Calcium channel blockers for antipsychotic-induced tardive dyskinesia.

Sat, 2018-04-28 07:27
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Calcium channel blockers for antipsychotic-induced tardive dyskinesia.

Cochrane Database Syst Rev. 2018 03 26;3:CD000206

Authors: Essali A, Soares-Weiser K, Bergman H, Adams CE

Abstract
BACKGROUND: Schizophrenia and related disorders affect a sizable proportion of any population. Antipsychotic medications are the primary treatment for these disorders. Antipsychotic medications are associated with a variety of adverse effects including tardive dyskinesia. Dyskinesia is a disfiguring movement disorder of the orofacial region that can be tardive (having a slow or belated onset). Tardive dyskinesia is difficult to treat, despite experimentation with several treatments. Calcium channel blockers (diltiazem, nifedipine, nimodipine, verapamil, flunarizine) have been among these experimental treatments.
OBJECTIVES: To determine the effects of calcium channel blocker drugs (diltiazem, nifedipine, nimodipine, verapamil) for treatment of neuroleptic-induced tardive dyskinesia in people with schizophrenia, schizoaffective disorder or other chronic mental illnesses.
SEARCH METHODS: We searched the Cochrane Schizophrenia Group Trials Register (July 2015 and April 2017), inspected references of all identified studies for further trials and contacted authors of trials for additional information.
SELECTION CRITERIA: We selected randomised controlled trials comparing calcium channel blockers with placebo, no intervention or any other intervention for people with both tardive dyskinesia and schizophrenia or serious mental illness who remained on their antipsychotic medication.
DATA COLLECTION AND ANALYSIS: We independently extracted data and estimated risk ratios of dichotomous data or mean differences (MD) of continuous data, with 95% confidence intervals (CI). We assumed that people who left the trials early had no improvement. We also created a 'Summary of findings' table using GRADE.
MAIN RESULTS: Previous versions of this review included no trials. From the 2015 search, we identified three cross-over trials that could be included. The 2017 search found no new studies relevant to this review. The included trials randomised 47 inpatients with chronic mental illnesses in the USA and China. Trials were published in the 1990s and were of short duration (six to 10 weeks). Overall, the risk of bias was unclear, mainly due to poor reporting; allocation concealment was not described, generation of the sequence was not explicit, studies were not clearly blinded, and attrition and outcome data were not fully reported. Findings were sparse, no study reported on the primary outcome 'no clinically important improvement in tardive dyskinesia symptoms,' but two small studies (37 participants) found no difference on the tardive dyskinesia symptoms scale Abnormal Involuntary Movement Scale (AIMS) scores between diltiazem or flunarizine and placebo after three to four weeks' treatment (MD -0.71, 95% CI -2.68 to 1.26, very low quality evidence). Only one study randomising 20 participants reported on adverse events, and reported that there were no adverse events with flunarizine or with placebo (very low quality evidence). One study with 18 participants reported no events of deterioration in mental state with diltiazem or with placebo (very low quality evidence). No studies reported on acceptability of treatment or on social confidence, social inclusion, social networks or personalised quality of life outcomes designated important to patients.
AUTHORS' CONCLUSIONS: Available evidence from randomised controlled trials is extremely limited and very low quality, conclusions cannot be drawn. The effects of calcium channel blockers for antipsychotic-induced tardive dyskinesia are unknown. Their use is experimental and should only be given in the context of well-designed randomised trials.

PMID: 29578611 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Evaluating quality of life in epilepsy: The role of screening for adverse drug effects, depression, and anxiety.

Sat, 2018-04-28 07:27
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Evaluating quality of life in epilepsy: The role of screening for adverse drug effects, depression, and anxiety.

Epilepsy Behav. 2017 Oct;75:18-24

Authors: Micoulaud-Franchi JA, Bartolomei F, Duncan R, McGonigal A

Abstract
OBJECTIVE: The objective of this study was to evaluate the contribution of validated screening tools for antiepileptic drug (AED) adverse effects, depression, and anxiety to measure the quality of life (QoL) in people with epilepsy (PWE).
METHODS: Patients in a tertiary epilepsy service were screened for quality of life (using QOLIE-31), major depressive disorder (MDD) (NDDI-E), generalized anxiety disorder (GAD) (GAD-7), and AED effects (AEP). Mini International Neuropsychiatric Interview (MINI) generalized anxiety disorder module was also performed. For AEP validation in French, the internal structural validity was analyzed. Dimensional (NDDI-E and GAD-7 scores) and categorical (MDD and GAD) analyses were performed to investigate interactions between QoL and AEP.
RESULTS: A total of 132 (87 females) subjects were included. The French version of the AEP demonstrated satisfactory psychometric properties (Cronbach's α 0.87). Correlations between NDDI-E, GAD-7, AEP, and QOLIE-31 scores were high, and significant for all subscales of QOLIE-31; no effect of seizure-related variables was seen. Some sex differences in QOLIE-31 subscales were found, and mean AEP score was higher in females. Age, sex, NDDI-E, GAD-7, and AEP scores accounted for 61% of variance of QOLIE-31 scores. Differential effects were seen on QOLIE-31 subscales: AEP strongly correlated with all subscales; GAD-7 scores more strongly correlated with "Seizure Worry"; NDDI-E with "Energy-Fatigue"; and both NDDI-E and GAD-7 scores strongly correlated with "Emotional Well-Being". Categorical analysis of groups with MDD alone, GAD alone, MDD+GAD, and neither MDD nor GAD showed significant differences in AEP and QOLIE-31 scores, with MDD+GAD showing the most AED effects and the poorest QoL.
SIGNIFICANCE: The combination of screening tools for depression (NDDI-E), anxiety (GAD-7), and AED effects (AEP) has a strong power for evaluating QoL in PWE. Coexisting MMD and GAD were associated with the poorest quality of life and the highest AEP scores.

PMID: 28818810 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Safety of Cancer Therapies: At What Cost?

Sat, 2018-04-28 07:27
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Safety of Cancer Therapies: At What Cost?

Popul Health Manag. 2017 Aug;20(4):318-328

Authors: Fitzner K, Oteng-Mensah F, Donley P, Heckinger EAF

Abstract
The cost of cancer drugs has increased concurrently with drug safety resulting in both increased survivorship and increased out-of-pocket costs and co-payments for patients. This article evaluates the interplay between patient safety and cancer drug costs to determine how cancer drug costs affect patient safety and well-being. A literature review was performed that identified the main drivers of drug safety costs: drug-drug interactions, adverse drug events, medication errors, and nonadherence. Three main types of costs were identified: out-of-pocket spending, drug cost growth, and safety-related costs. Insured patients receiving chemotherapy pay an average of $10,000/month on out-of-pocket expenses. Annual drug cost growth has been as much as 21% in recent years. Over a span of 13 years, 1999-2013, insurance premiums and out-of-pocket payments have increased by 182% and 200%, respectively. Safety-related concerns include the high cost of developing a new drug, estimated at $5 billion. The cost of development is reflected in the cost of the 12 new cancer drugs that received Food and Drug Administration approval in 2012; 11 were priced at 6 figures. Although advances in pharmaceutical technology and research have yielded effective cancer therapies that reduce physical or treatment-related toxicity, patients have had to face worsening financial uncertainty both during and after treatment. Actions are needed to achieve financial safety, as well as therapeutic and clinical safety, for cancer patients.

PMID: 28112578 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in children: 20 years study in a tertiary care hospital.

Sat, 2018-04-28 07:27
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Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in children: 20 years study in a tertiary care hospital.

World J Pediatr. 2017 Jun;13(3):255-260

Authors: Techasatian L, Panombualert S, Uppala R, Jetsrisuparb C

Abstract
BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe lifethreatening skin conditions. The most common cause of these manifestations is medications. Beside discontinued of the culprit drug, systemic corticosteroids were used as a primary treatment option among pediatric population. This study aimed to explore causative drugs (drug group/ latent period), treaments, complications, and treatment outcome (morbidity, mortality, length of hospital stay) of SJS and TEN in children.
METHODS: A retrospective chart was reviewed during the period of 1992 to 2012 at Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand. SJS and TEN were clinically diagnosed and confirmed by pediatric dermatologists. Other possible causes other than druginduced SJS and TEN were excluded.
RESULTS: A total of 30 patients was recorded, including 24 (80%) SJS patients and 6 (20%) TEN patients. The mean age was 6.9 years (SD 4.4). Male to female ratio was 1.5:1. Antiepileptic drug group was the most common causative drug (n=18, 60%), followed by antibiotic drug group (n=8, 26.6%), and others (n=4, 13.3%) which included nonsteroidal antiinflammtory drugs (NSAIDs) and chemotherapy drugs. Systemic corticosteroids were used in 29 patients (96.6%). Intravenous immunoglobulin was used in one TEN patient (3.3%). There was a medium correlation between time to treatment (systemic corticosteroids) and the length of hospital stay (Spearman correlation coefficient=0.63, P=0.005). Two TEN patients (6.6%) died.
CONCLUSIONS: Carbamazepine was the most common causative drug of SJS and TEN in our study. The severity of skin detachment is not correlated to severity of ocular findings. However, the persistent of ocular complications up to one year is suggested for promptly appropriate ocular treatment in all SJS and TEN patients. Our data suggested that early administration of systemic corticosteroid may reduce the length of hospital stay and should be considered for the treatment of pediatric druginduced SJS and TEN.

PMID: 27650525 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Meaningful Use IT reduces hospital-caused adverse drug events even at challenged hospitals.

Sat, 2018-04-28 07:27
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Meaningful Use IT reduces hospital-caused adverse drug events even at challenged hospitals.

Healthc (Amst). 2015 Mar;3(1):12-7

Authors: Encinosa WE, Bae J

Abstract
BACKGROUND: many Meaningful Use (MU) requirements involve medication management. Little is known about what impact these will have on adverse drug events (ADEs) at challenged hospitals.
METHODS: we use the Florida State Inpatient Database (HCUP, AHRQ), the AHA IT Supplement, and Hospital Compare. Controlling for non-response selection bias, we use multi-level GLLAMM regression analysis to examine the impact of the 5 core MU medication elements on hospital-caused ADEs.
RESULTS: adopting all 5 core MU elements was associated with a reduction in ADEs. Hospitals reporting costs as the main barrier to MU reduced their ADE rates by 35%; low quality hospitals reduced ADEs by 29%, compared to 27% at high quality hospitals. Among hospitals reporting these medication elements among their top MU challenges, ADEs were reduced by 69%, compared to 45% for hospitals with no drug functions as their top MU challenges. However, ADEs increased by 14% at hospitals with physician resistance to MU, compared to a 52% ADE reduction without physician resistance.
CONCLUSIONS: the bundling all five medication functions in MU is associated with large reductions in ADEs.
IMPLICATIONS: without physician buy-in at the hospital, MU will have no impact on ADEs.

PMID: 26179584 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +12 new citations

Fri, 2018-04-27 09:57

12 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2018/04/27

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Categories: Literature Watch

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +11 new citations

Fri, 2018-04-27 06:00

11 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2018/04/27

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Categories: Literature Watch

In response to: "Pharmacokinetic modelling of modified acetylcysteine infusion regimens used in the treatment of paracetamol poisoning".

Thu, 2018-04-26 06:22
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In response to: "Pharmacokinetic modelling of modified acetylcysteine infusion regimens used in the treatment of paracetamol poisoning".

Eur J Clin Pharmacol. 2018 02;74(2):251

Authors: Harmouche E, Howland MA, K Su M

PMID: 29159489 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Knowledge, Attitude and Practice Regarding Pharmacovigilance and Consumer Pharmacovigilance among Consumers at Lalitpur District, Nepal.

Thu, 2018-04-26 06:22
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Knowledge, Attitude and Practice Regarding Pharmacovigilance and Consumer Pharmacovigilance among Consumers at Lalitpur District, Nepal.

J Nepal Health Res Counc. 2017 Jan;15(35):31-37

Authors: Jha N, Rathore DS, Shankar PR, Bhandary S, Alshakka M, Gyawali S

Abstract
BACKGROUND: Adverse drug reactions (ADRs) can be a big threat to the health of people in Nepal as a variety of medicines are consumed in the country. Involving consumers in pharmacovigilance can strengthen ADR reporting. The study aims to find out knowledge, attitude and practice regarding pharmacovigilance and consumer pharmacovigilance among consumers at Lalitpur district, Nepal Methods: It was carried out in outpatients visiting in KIST Medical College and Teaching Hospital, Lalitpur, Nepal. Participant's knowledge, attitude and practice were measured by noting their agreement with a set of 21 statements along with multiple choice and open ended questions.
RESULTS: A total of 157 outpatients were surveyed. The knowledge scores for males (12) was better compared to the females (11), but the scores for attitude and practice were same for both groups. The maximum score for knowledge was 29, attitude was 6 and practice was 10. The overall KAP scores was 45. The total scores for knowledge, attitude and practice for males (24) were better compared to female (22) respondents. Seventy-one patients (68%) who participated in this study favoured establishing a consumer centre for obtaining information about ADRs.
CONCLUSIONS: Knowledge scores among consumers regarding pharmacovigilance is low and require advocacy and improvement.

PMID: 28714489 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database.

Thu, 2018-04-26 06:22
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Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database.

Psychiatry Res. 2017 Oct;256:237-242

Authors: Kim S, Park K, Kim MS, Yang BR, Choi HJ, Park BJ

Abstract
Selective serotonin reuptake inhibitors (SSRIs) have become one of the most broadly used medications in psychiatry. Fluoxetine is the first representative antidepressant SSRI drug approved by the Food and Drug Administration (FDA) in 1987. Safety information on fluoxetine use alone was less reported than its combined use with other drugs. There were no published papers on adverse drug reactions (ADRs) of fluoxetine analyzing spontaneous adverse events reports. We detected signals of the adverse drug reactions of fluoxetine by data mining using the Korea Adverse Events Reporting System (KAERS) database. We defined signals in this study by the reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) indices. The KAERS database included 860,224 AE reports, among which 866 reports contained fluoxetine. We compared the labels of fluoxetine among the United States, UK, Germany, France, China, and Korea. Some of the signals, including emotional lability, myositis, spinal stenosis, paradoxical drug reaction, drug dependence, extrapyramidal disorder, adrenal insufficiency, and intracranial hemorrhage, were not labeled in the six countries. In conclusion, we identified new signals that were not known at the time of market approval. However, certain factors should be required for signal evaluation, such as clinical significance, preventability, and causality of the detected signals.

PMID: 28646789 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Amiodarone-induced thyroid dysfunction and a perturbed N-desethyl-amiodarone to amiodarone ratio: could a drug-induced toxicity be regulating exposure to the offending agent?

Thu, 2018-04-26 06:22
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Amiodarone-induced thyroid dysfunction and a perturbed N-desethyl-amiodarone to amiodarone ratio: could a drug-induced toxicity be regulating exposure to the offending agent?

Eur J Clin Pharmacol. 2017 08;73(8):1051-1052

Authors: Rowland A, Rowland A, Sorich MJ, Mangoni AA

PMID: 28470396 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Response: Amiodarone-induced thyroid dysfunction and a perturbed N-desethyl-amiodarone to amiodarone ratio; could a drug-induced toxicity be regulating exposure to the offending agent?

Thu, 2018-04-26 06:22
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Response: Amiodarone-induced thyroid dysfunction and a perturbed N-desethyl-amiodarone to amiodarone ratio; could a drug-induced toxicity be regulating exposure to the offending agent?

Eur J Clin Pharmacol. 2017 08;73(8):1053-1054

Authors: Takada M, Yamato M, Wada K, Fujimoto M, Hosomi K, Hayashi T, Oita A

PMID: 28456822 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Ipilimumab-induced thrombotic thrombocytopenic purpura (TTP).

Thu, 2018-04-26 06:22
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Ipilimumab-induced thrombotic thrombocytopenic purpura (TTP).

J Immunother Cancer. 2017;5:19

Authors: King J, de la Cruz J, Lutzky J

Abstract
BACKGROUND: CTLA-4 (Cytotoxic T-lymphocyte-associated protein 4) was the first immune checkpoint receptor clinically targeted for use in cancer treatment. It is expressed exclusively on T-cells where its primary role is to regulate the amplitude of the early stages of T-cell activation.1 Ipilimumab, a CTLA-4 blocking antibody, has been widely used for the treatment of patients with high risk and metastatic melanoma. Given its mechanism of action and consequent immune activation, the side effect profile of this drug greatly differs from that of standard cytotoxic chemotherapy. Adverse events are from the most part immune-mediated, ranging from the more common, such as rash and fatigue, to the less common, such as immune endocrinopathy and colitis.
CASE PRESENTATION: We describe a case of immune-mediated thrombotic thrombocytopenic purpura (TTP) in a 68 year-old woman with high risk, stage III melanoma occurring after 3 cycles of adjuvant treatment with ipilimumab as part of a clinical trial.
CONCLUSION: The range of immune-mediated adverse events during treatment with ipilimumab is wide and varied and clinicians should have a high degree of suspicion when managing these patients.

PMID: 28344807 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Sudden hearing loss in a melanoma patient on pembrolizumab: an etiology not to be omitted in the differential diagnosis.

Thu, 2018-04-26 06:22
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Sudden hearing loss in a melanoma patient on pembrolizumab: an etiology not to be omitted in the differential diagnosis.

J Immunother Cancer. 2017;5:24

Authors: Nader ME, Myers JN, Gidley PW

Abstract
Immune checkpoint inhibitors have emerged as a promising therapeutic option for metastatic cancers. However, they have been associated with inflammatory adverse reactions in various organ systems. A recent article reported a case of sudden bilateral hearing loss that occurred in a patient with metastatic melanoma being treated with pembrolizumab. The authors attributed that complication to an autoimmune reaction secondary to the treatment. This commentary discusses the importance of considering the diagnosis of leptomeningeal metastasis in patients with metastatic melanoma who present with new cranial nerve deficits.

PMID: 28331614 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Interstitial nephritis in melanoma patients secondary to PD-1 checkpoint inhibitor.

Thu, 2018-04-26 06:22
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Interstitial nephritis in melanoma patients secondary to PD-1 checkpoint inhibitor.

J Immunother Cancer. 2017;5:3

Authors: Escandon J, Peacock S, Trabolsi A, Thomas DB, Layka A, Lutzky J

Abstract
BACKGROUND: Immune checkpoint inhibitors have become the first line therapy in melanoma treatment and their use is extending to other malignancies. However, we are still learning about immune side effects produced by these drugs and their severity especially in patients with history of inflammatory diseases.
CASE PRESENTATION: We present two cases of metastatic melanoma treated with nivolumab and pembrolizumab (anti PD-1). Both patients developed acute interstitial nephritis during immune checkpoint therapy. We emphasize the causal association between immune checkpoint inhibitors and the nephritis. The timing of drug administration and appearance of nephritis is suggestive of a causal relation between the checkpoint inhibitor therapy and this adverse event.
CONCLUSIONS: Although uncommon, some side effects from checkpoint inhibitors can be severe and may need to be addressed with immunosuppression. Given the increasing frequency of immunotherapy use, awareness should be raised in regards to immune side effects and their appropriate management.

PMID: 28105370 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Evidence-based pain medicine for primary care physicians.

Wed, 2018-04-25 15:02
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Evidence-based pain medicine for primary care physicians.

Proc (Bayl Univ Med Cent). 2018 Jan;31(1):37-47

Authors: Owen GT, Bruel BM, Schade CM, Eckmann MS, Hustak EC, Engle MP

Abstract
The last several decades have seen a marked increase in both the recognition and treatment of chronic pain. Unfortunately, patients frequently misunderstand both the nature of pain and the best practices for its treatment. Because primary care physicians treat the majority of chronic pain, they are ideally situated to provide evidence-based pain care. The majority of the medical evidence supports a biopsychosocial model of pain that integrates physical, emotional, social, and cultural variables. The goal of this primer is to assist primary care physicians in their understanding of pain, evaluation of the chronic pain patient, and ability to direct evidence-based care. This article will discuss the role of physical rehabilitation, pain psychology, pharmacotherapy, and procedural interventions in the treatment of chronic pain. Given the current epidemic of drug-related deaths, particular emphasis is placed on the alternatives to opioid therapy. Unfortunately, death is not the only significant complication from opioid therapy, and this article discusses many of the most common side effects. This article provides general guidelines on the most appropriate utilization of opioids with emphasis on the recent Centers for Disease Control and Prevention guidelines, risk stratification, and patient monitoring. Finally, the article concludes with the critical role that a pain medicine specialist can play in the management of patients with chronic pain.

PMID: 29686550 [PubMed]

Categories: Literature Watch

Frequency of Severe Infusion Reactions Associated With Outpatient Infusion of Infliximab Without Premedications.

Wed, 2018-04-25 15:02
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Frequency of Severe Infusion Reactions Associated With Outpatient Infusion of Infliximab Without Premedications.

J Pediatr Gastroenterol Nutr. 2017 10;65(4):430-431

Authors: Hutsell SQ, Wu M, Park KT

Abstract
In this report, we describe incremental changes, during a 2-year period at a single center with the administration of maintenance infliximab infusions. Given practice-driven changes consisting of 1-hour infusions and omission of premedications, we aimed to investigate if these changes contributed to severe infusion reactions. We reviewed approximately 900 infliximab infusions in a pediatric ambulatory infusion center from January 1, 2014, to December 31, 2015, for severe adverse reactions requiring either rescue epinephrine or a code blue or "rapid response" activation. In 2015, these practice changes resulted in a 51% decrease in total infusion hours (1281 to 630 infusion hours), despite a 9% increase in total number of infusions. No increase in severe adverse events associated with either rapid 1-hour infusion or omission of premedications. Our findings highlight a quality-improvement opportunity to standardize infliximab infusions to streamline care in an ambulatory setting.

PMID: 28937551 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database.

Wed, 2018-04-25 15:02
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Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database.

Paediatr Drugs. 2018 Feb;20(1):81-87

Authors: Durrieu G, Maupiler M, Rousseau V, Chebane L, Montastruc F, Bondon-Guitton E, Montastruc JL

Abstract
INTRODUCTION: Studies that evaluate the safety of non-prescription drugs in children remain scarce.
OBJECTIVES: The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children.
METHODS: We conducted a retrospective analysis of ADR notifications for a pediatric population (aged <18 years) registered in the French PharmacoVigilance Database (FPVD) between January 1985 and December 2016 by the Midi-Pyrénées PharmacoVigilance Center (in the south of France). We compared ADR profiles according to drug prescription status using a Chi-squared test.
RESULTS: We included 2218 notifications concerning 3687 ADRs in the study. Non-prescription drugs were involved in 506 notifications (22.8%). Patients were younger in the non-prescription drug group (6.7 ± 5.3 vs. 8.4 ± 5.7 years in the prescription drug group). No difference by sex was found. Neurological ADRs were more frequent with prescription drugs (21.0%) than with non-prescription drugs (14.2%, p = 0.0008), whereas dermatological disorders (37.2 vs. 29.1%, respectively) and general ADRs (30.8 vs. 20.1%, respectively) were more frequent with non-prescription than with prescription drugs (p = 0.0006 and p < 0.0001, respectively). The frequency of "serious" ADRs was higher with prescription drugs than with non-prescription drugs (40.9 vs. 34.2%, p = 0.007). The non-prescription drugs most frequently implicated with serious ADRs were ibuprofen (n = 37; 4.2%), tuberculosis vaccine (n = 23; 2.6%), aspirin (n = 20, 2.3%), and paracetamol (n = 17; 1.9%). ADRs from prescription drugs involved asparaginase (n = 27; 3.1%), immunoglobulins (n = 25; 2.9%), and amoxicillin (n = 23; 2.4%).
CONCLUSIONS: Non-prescription drugs, usually considered safe, were frequently responsible for ADR notifications. The non-prescription medication most frequently involved in serious ADRs was ibuprofen.

PMID: 28766184 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

[Drug-induced iatrogenic arthropathies].

Wed, 2018-04-25 15:02
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[Drug-induced iatrogenic arthropathies].

Rev Med Suisse. 2017 Mar 08;13(553):559-564

Authors: Zufferey P

Abstract
Arthropathies induced by drugs, especially arthralgias, are very frequently reported in pharmacology. The major difficulty often consists in confirming the accountability of the drug in the occurrence of the symptoms. Stopping the drug when it really responsible of the arthralgia is then likely to lead to the disappearance of the symptoms. The aim of this article is to review some of classical known induced arthropathies and some innovations by describing the clinical characteristics as well as the mechanisms linking the drug to the arthropathies when these have been clarified.

PMID: 28718589 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

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