15 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 2018/07/24

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16 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 2018/07/22

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.

Communicating risk of medication side-effects: role of communication format on risk perception.

Pharm Pract (Granada). 2018 Apr-Jun;16(2):1174

Authors: Sawant R, Sansgiry S

Abstract
Background: Medication side-effects often arouse fear in the minds of consumers and therefore need to be communicated in a manner such that the intended message is clearly understood, without causing undue fear.
Objectives: Considering the message format and contextual factors that influence perceptions of risk, this study aimed at assessing the interaction effects of message format and contextual factors (rate of occurrence and severity) on risk perception of medication side-effects.
Methods: Using Rhormann's risk communication process model, a 2 (message format: words-only vs. words + numeric) X 2 (rate of occurrence: high vs low) X 2 (severity: mild vs severe) experimental factorial study was designed. Participants were presented with four of eight possible combinations of the three factors and were asked to indicate the risk perception with the associated side-effects. Repeated measures analysis was conducted while adjusting for control variables.
Results: A total of 196 completed surveys were collected. Communication format did not have significant main effect on risk perception (P=0.4237) but demonstrated a significant interaction with rate of occurrence (P=0.0001). As compared to words-only format, least square means for words + numeric format were lower among low-rate side-effects but were higher among high-rate side-effects. Rate of occurrence (P<0.0001) and severity (P<0.0001) had significant main effects on risk perception as well as interaction effect with each other (P<0.0001).
Conclusions: The results indicated that effect of communication format on risk perception of side-effect is dependent on the underlying rate of occurrence of side-effect. Healthcare providers should therefore carefully construct risk communication messages for effective communication with patients.

PMID: 30023029 [PubMed]

Phase 2 study of gandotinib (LY2784544) in patients with myeloproliferative neoplasms.

Leuk Res. 2018 Jun 30;71:82-88

Authors: Berdeja J, Palandri F, Baer MR, Quick D, Kiladjian JJ, Martinelli G, Verma A, Hamid O, Walgren R, Pitou C, Li PL, Gerds AT

Abstract
BACKGROUND: The Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs) are associated with increases in janus kinase 2 (JAK2) signaling, often resulting from the JAK2 V617F mutation. LY2784544 (gandotinib) is a potent, selective, small-molecule inhibitor of JAK2 that has potential dose-dependent selectivity for the JAK2 V617F mutation and may inhibit additional JAK2 mutant isoforms in nonclinical testing.
METHODS: A multicenter, single-arm, outpatient phase 2 study evaluated the efficacy, safety, and pharmacokinetics (PK) of gandotinib administered to patients (120 mg once daily) with MPNs, including polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF). Between May 2012 and March 2015, 138 patients received at least one dose of study drug.
FINDINGS: Most frequent Grade 3 or 4 treatment-emergent adverse events that were considered study-drug related were anemia (11.6%), hyperuricemia (3.2%), fatigue (2.9%), diarrhea (2.2%), and thrombocytopenia (2.2%). Overall response rates (ORRs) in patients with JAK2 V617F-mutated PV, ET, and MF were 95%, 90.5%, and 9.1%, respectively, while patients with ET and MF without the JAK2 V617F mutations had ORRs of 43.7% and 0%, respectively.
INTERPRETATIONS: LY2784544 demonstrated efficacy in JAK2 V617F-mutated MPNs, including in patients previously on ruxolitinib therapy, who had an ORR of 3.3%. At the 1-year visit, 44% of patients experienced a ≥50% improvement in the MPN-Symptom Assessment Form Total Symptom Score, and 26% of patients had a 50% reduction in Brief Fatigue Inventory score.

PMID: 30025280 [PubMed - as supplied by publisher]

Antiarrhythmic drug-induced smell and taste disturbances: A case report and literature review.

Medicine (Baltimore). 2018 Jul;97(29):e11112

Authors: Che X, Li Y, Fang Y, Reis C, Wang H

Abstract
RATIONALE: Metoprolol and amiodarone are common antiarrhythmic drugs used in clinics throughout the world. The taste and smell alterations induced by antiarrhythmic drugs remain uncommon throughout the world, with less than 10 reported cases.
PATIENT CONCERNS: In this case report, we describe a case of a 73-year-old female, diagnosed with arrhythmias, was treated for metoprolol. At the third week of metoprolol treatment, the patient noticed a qualitative change in her ability to smell, also called dysosmia. After the metoprolol was tapered, her ability to smell was recovered. However, her arrhythmia was getting worse and the patient was given amiodarone. After using amiodarone for about 2 weeks, the patient felt hypogeusia, or loss of taste sensation.
DIAGNOSES: The patient was diagnosed as dysosmia and taste disturbance induced by the antiarrhythmic drugs.
INTERVENTIONS: After noticed the side effects of the antiarrhythmic drugs, we asked the patient to abandon the drugs and have a radiofrequency ablation.
OUTCOMES: Her ability of smell and taste were recovered after withdrawing the antiarrhythmic drugs. Also, in the follow-up appointment, she reported no complaints of smell or taste anymore.
LESSONS: These rare sensory disorders induced by anti-arrhythmic drugs were less documented in past literature. Our case report describes a patient with an arrhythmia who suffered reversible dysosmia and hypogeusia after taking metoprolol and amiodarone, respectively. We conclude that smell and taste disorders should be made aware to patients during the anti-arrhythmic treatment, helping to promote the safety of patients and drug compliance.

PMID: 30024498 [PubMed - in process]

[Recording and assessment of medication errors : Experience of the Drug Commission of the German Medical Association].

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Jul 18;:

Authors: Köberle U, Stammschulte T, Gundert-Remy U, Pitzer M, Bräutigam K

Abstract
Adverse drug reactions (ADRs) are a common problem in daily clinical practice and they may in part result from medication errors. According to the extended interpretation in the new European pharmacovigilance guideline, medication error-related reactions are classified as ADRs. Therefore, the pharmacovigilance system needs to be adjusted to record medication errors. As a partner in the German pharmacovigilance system, the Drug Commission of the German Medical Association (DCGMA) has set up a project for developing a subsystem for the recording and assessment of medication errors within the existing spontaneous reporting system for ADRs. The aim of the project was to evaluate the feasibility of recording and assessing medication errors within the existing structures and to investigate whether it is possible to deduce risk-reducing strategies from the information obtained by the case reports. In the present narrative review, the experience of the DCGMA with the recording and assessment of medication errors is described. The conclusions and recommendations from the analysis of the reports of medication errors show how they can be used to improve medication safety. The project has closed a gap in pharmacovigilance.

PMID: 30022236 [PubMed - as supplied by publisher]

Randomized, placebo-controlled trial of ADS-5102 (amantadine) extended-release capsules for levodopa-induced dyskinesia in Parkinson's disease (EASE LID 3).

Mov Disord. 2017 Dec;32(12):1701-1709

Authors: Oertel W, Eggert K, Pahwa R, Tanner CM, Hauser RA, Trenkwalder C, Ehret R, Azulay JP, Isaacson S, Felt L, Stempien MJ

Abstract
BACKGROUND: The treatment of levodopa-induced dyskinesia in Parkinson's disease (PD) is an unmet need with no approved drug therapy.
OBJECTIVE: The purpose of this study was to investigate the efficacy and safety of 274 mg ADS-5102 (amantadine) extended-release capsules (equivalent to 340-mg amantadine HCl) for levodopa-induced dyskinesia in a randomized controlled trial.
METHODS: PD patients with ≥1 hour of troublesome dyskinesia and at least mild functional impact were randomized to placebo or ADS-5102 once daily at bedtime for 13 weeks. The primary efficacy analysis was based on change from baseline to week 12 on the Unified Dyskinesia Rating Scale total score in the modified intent-to-treat population. OFF time was a key secondary measure.
RESULTS: At week 12, least-squares mean change in the Unified Dyskinesia Rating Scale was -20.7 (standard error 2.2) for ADS-5102 (n = 37) and -6.3 (standard error 2.1) for placebo (n = 38; treatment difference -14.4, 95% confidence interval -20.4 to -8.3, P < .0001), indicating improvement in levodopa-induced dyskinesia. OFF time decreased 0.5 hours (standard error 0.3) for ADS-5102 from a baseline mean of 2.6 hours and increased 0.6 hours (standard error 0.3) for placebo from a baseline mean of 2.0 hours (treatment difference -1.1 hours, 95% confidence interval -2.0 to -0.2, P = .0199). The most common adverse events (ADS-5102 versus placebo) included dry mouth (13.5% versus 2.6%), nausea (13.5% versus 2.6%), decreased appetite (10.8% versus 0%), insomnia (10.8% versus 0%), orthostatic hypotension (10.8% versus 0%), constipation (8.1% versus 0%), falls (8.1% versus 5.3%), and visual hallucinations (8.1% versus 5.3%). Adverse events led to treatment discontinuation in 19% versus 8%, respectively.
CONCLUSION: ADS-5102 274 mg is an oral pharmacotherapy demonstrating a significant decrease in levodopa-induced dyskinesia and improving OFF time. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

PMID: 28833562 [PubMed - indexed for MEDLINE]

Clinical Effects of Piribedil in Adjuvant Treatment of Parkinson's Disease: A Meta-Analysis.

Open Med (Wars). 2018;13:270-277

Authors: Peihua L, Jianqin W

Abstract
OBJECTIVE: To evaluate the clinical effects of piribedil in adjuvant treatment of Parkinson's Disease (PD) by pooling previously openly published studies.
METHODS: The related electronic databases of Medline (1960~2017.5), Cochrane central register of controlled trials (CENTRAL), EMBASE (1980~2017.5) and Wanfang (1986~20175.5) were searched by two reviewers (Lu Peihua and Wang Jianqian) independently for publications including the topic of prospective randomized controlled trials about clinical effects of piribedil in adjuvant treatment of PD. The data of each included study was extracted and pooled by Stata11.0 software (for meta-analysis). The statistical heterogeneity across the studies was evaluated by I2 test and the publication bias was calculated by begg's funnel plot and Egger's line regression test.
RESULTS: After searching the related electronic databases of Medline, CENTRAL, EMBSE and Wanfang databases, 11 clinical studies were included in this meta-analysis. The pooled RR (random effect model) of clinical efficacy was 1.29 (95%CI:1.18~1.41, P=4×10-3) indicating the clinical efficacy of piribedil group was signficat higher than those of control group. The standard mean difference (SMD) for UPDRS score changed before and after treatment was pooled by random effect model. The combined SMD was -0.41 (95%CI:-0.75~-0.06). For piribedil related side effects, the combined data indicated that there was no statistical difference for nausea and vomiting (RR=0.43, 95%CI:0.41~1.69, P=0.61), mental disorders (RR=0.85, 95%CI:0.45~1.59, P=0.61) and other toxicities (RR=0.32, 95%CI:0.09~1.16, P=0.08).
CONCLUSION: Piribedil combined with Levodopa in adjuvant treatment of PD is more effective than Levodopa alone without increasing the drug related toxicity.

PMID: 30019007 [PubMed]

Phase I study of TrasGEX, a glyco-optimised anti-HER2 monoclonal antibody, in patients with HER2-positive solid tumours.

ESMO Open. 2018;3(4):e000381

Authors: Fiedler W, Stoeger H, Perotti A, Gastl G, Weidmann J, Dietrich B, Baumeister H, Danielczyk A, Goletz S, Salzberg M, De Dosso S

Abstract
Purpose: TrasGEX is a second-generation monoclonal antibody of trastuzumab, glyco-optimised to enhance antibody-dependent cellular cytotoxicity while fully retaining trastuzumab's antigen-binding properties to human epidermal growth factor receptor 2 (HER2). A phase I dose-escalation study was conducted to establish the optimal TrasGEX dose and regimen for phase II studies and to define the safety, pharmacokinetics (PK) and preliminary antitumour activity of TrasGEX.
Patients and methods: A total of 37 patients with advanced HER2-positive carcinomas and progressive disease received TrasGEX intravenously every 3 weeks until disease progression in doses of 12-720 mg in a three-plus-three dose escalation design, including an expansion cohort at the highest dose.
Results: No dose limiting toxicity was observed, and no maximum tolerated dose was reached. Drug-related adverse events were mainly infusion-related reactions occurring during the first infusion in 51% of patients; all but two were mild-to-moderate. Compared with trastuzumab, the PK parameters were dose dependent, with a mean terminal half-life (t1/2) of 263±99 hours for the 720 mg dose. Clinical benefit in 15 out of 30 (50%) evaluable patients included one ongoing complete response, two partial remissions lasting 16 and 77 weeks and disease stabilisation (SD) in 12 patients lasting a median (range) of 17 (7-26) weeks; three of them had SD of 24, 25 and 26 weeks, respectively.
Conclusion: TrasGEX was safe, well-tolerated and showed antitumour activity in 50% of evaluable patients, all with progressive disease at study entry. Infusions at an interval of 2-3 weeks should achieve clinically relevant trough levels for future studies (NCT01409343).

PMID: 30018811 [PubMed]

Comparison of Preoperative Administration of Pregabalin and Duloxetine on Cognitive Functions and Pain Management after Spinal Surgery: A Randomized Double-blind Placebo-controlled Study.

Clin J Pain. 2018 Jul 16;:

Authors: Altıparmak B, Güzel Ç, Gümüş Demirbilek S

Abstract
STUDY OBJECTIVE: The surgical trauma is known to induce hyperalgesia and if pain management is insufficient, it contributes to persistent pain in the postoperative period.In this study, our primary aims are to compare the effect of pregabalin and duloxetine on postoperative pain scores and cognitive functions. Our secondary aim is to determine drug-related side-effects.
DESIGN: Prospective, randomized, double-blind, placebo-controlled.
SETTINGS: Operating room, surgical ward.
PATIENTS: Nintyfour patients,18-65 years of age, ASA status I-II, scheduled for elective repair of lumbar disc herniation.
INTERVENTIONS: The patients were randomly divided into three groups; the first group orally received pregabalin 75▒mg one hour prior to the surgery and at the postoperative 12 and 24 hours. The second group orally received duloxetine 60▒mg one hour prior to the surgery. At the postoperative 12 hour, they received a placebo capsule and at the 24 hour, they received duloxetine 60▒mg again. The third group orally received placebo capsules at all timepoints.
MEASUREMENTS: Postoperative pain evaluation was conducted using visual analogue scale (VAS) at postoperative first minute, 30 minute, first hour, 12, 24 and 48 hour. The preoperative and postoperative 6 hour cognitive functions were evaluated with Montreal Cognitive Assessment (MOCA) test.
MAIN RESULTS: There was a significant reduction in mean MOCA scores postoperatively in all groups (P<0.01). The highest MOCA score reduction was in pregabalin group (1,83±1,31 point), then in duloxetine group (1,16±0,82) and least decrease was in control group (0,49±0,61). At all timepoints mean VAS scores of pregabalin and duloxetine groups were similar to each other and they were lower than control groups (P<0.05).
CONCLUSIONS: Preoperative use of duloxetine 60▒mg can be an useful alternative to pregabalin 75▒mg as it has similar analgesic effect on postoperative pain with fewer drug-related cognitive function deterioration.

PMID: 30020088 [PubMed - as supplied by publisher]

A Randomized Clinical Trial of the Efficacy and Safety of Sitagliptin Compared with Dapagliflozin in Patients with Type 2 Diabetes Mellitus and Mild Renal Insufficiency: The CompoSIT-R Study.

Diabetes Obes Metab. 2018 Jul 18;:

Authors: Scott R, Morgan J, Zimmer Z, Lam RLH, O'Neill EA, Kaufman KD, Engel SS, Raji A

Abstract
AIMS: To compare the efficacy and safety of the DPP-4 inhibitor sitagliptin with the SGLT-2 inhibitor dapagliflozin in patients with type 2 diabetes and mild renal insufficiency.
MATERIALS AND METHODS: Patients with HbA1c 7.0 to 9.5% (53 to ≤80 mmol/mol) and eGFR 60 to <90 mL/min/1.73m2 on metformin (≥1500 mg/day) ± sulfonylurea were randomized to sitagliptin 100 mg (N=307) or dapagliflozin 5 mg titrated to 10 mg (N=306) once-daily for 24 weeks. A longitudinal data analysis model was used to test the primary hypothesis that sitagliptin is non-inferior to dapagliflozin in reducing HbA1c at Week 24, with superiority to be tested if non-inferiority is met.
RESULTS: Baseline mean HbA1c (% [mmol/mol]) was 7.7 (60.9) and 7.8 (61.2), and mean eGFR (mL/min/1.73m2 ) was 79.4 and 76.9 for the sitagliptin and dapagliflozin groups, respectively. After 24 weeks, the between-group difference in LS mean (95% CI) changes from baseline in HbA1c was -0.15% (-0.26,-0.04) (-1.67 mmol/mol [-2.86,-0.48]), p=0.006, meeting the prespecified criteria for declaring both non-inferiority and superiority of sitagliptin vs. dapagliflozin. HbA1c goal of <7% (<53 mmol/mol) was met by 43% (sitagliptin) and 27% (dapagliflozin) of patients. No meaningful between-group difference was observed in a pre-specified analysis of 2-hour incremental post-prandial glucose excursion. Review of adverse events (AEs) was notable for a lower incidence of drug-related AEs with sitagliptin compared with dapagliflozin.
CONCLUSIONS: In patients with type 2 diabetes, mild renal insufficiency and inadequate glycemic control on metformin ± sulfonylurea, sitagliptin treatment resulted in greater improvement in glycemic control compared with dapagliflozin and was generally well-tolerated. This article is protected by copyright. All rights reserved.

PMID: 30019498 [PubMed - as supplied by publisher]

Effect of Fluconazole on the Pharmacokinetics Properties of Imrecoxib, a Novel NSAID: A Single-center, Open-label, Self-controlled Study in Healthy Chinese Male Volunteers.

Clin Ther. 2018 Jul 13;:

Authors: Zuo CZ, Gong Y, Hou XY, Zhang YF, Peng WX, Zhu RH, Zhong DF, Chen XY

Abstract
PURPOSE: Imrecoxib is one type of cyclooxygenase-2 inhibitor with the capability of reducing the potential cardiovascular risk caused by other NSAIDs. Co-administration with other medications can affect the cytochrome P450 (CYP) 2C9 enzyme function; thus, imrecoxib metabolism can be affected. The purpose of this research was to evaluate the effects of fluconazole, which is known to inhibit CYP2C9, on imrecoxib's pharmacokinetic (PK) parameters.
METHODS: In this single-center, single-arm, open-label, self-controlled study, 12 healthy Chinese male volunteers (mean [SD] age, 22.6 [2.43] years) received the following 2 treatments separated by a washout period of 8days under a fasting state: (1) a single oral dose of imrecoxib 100 mg; and (2) fluconazole 200mg/d over 6days followed by concurrent dosing of imrecoxib 100mg and fluconazole 200mg. Plasma concentrations of imrecoxib (M0) and its metabolites (4'-hydroxymethyl metabolite [M1] and 4'-carboxylic acid metabolite [M2]) for PK analysis were obtained at 0 (baseline) and 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, and 72hours after imrecoxib dosing. Safety and tolerability assessments were performed throughout the study.
FINDINGS: All subjects completed the study. There was 1 adverse event; drug-induced liver damage in 1 subject occurred after he received imrecoxib plus fluconazole, and the subject recovered without any sequelae. Coadministration with fluconazole resulted in much higher plasma imrecoxib concentrations, with an increase of 88% in Cmax and 72% in AUC0-t compared with only imrecoxib treatment, which showed that fluconazole may increase plasma exposure to imrecoxib. Fluconazole also caused a small, but not clinically relevant, decrease in M1 and M2 mean Cmax (13% and 14%, respectively), but there was minimal change in M1 and M2 mean AUC0-t (3% and 2%). However, there were no statistically significant differences in vital signs, clinical laboratory test results, ECGs, or adverse events between treatments.
IMPLICATIONS: Concurrent administration of imrecoxib and fluconazole did not seem to change imrecoxib's safety profile. The ratio (imrecoxib + fluconazole/imrecoxib) for AUC0-t was 1.72 (90% CI, 1.41-2.11) and for Cmax it was 1.88 (90% CI, 1.59-2.21). Hence, it is necessary to adjust the imrecoxib dose when it is concurrently used with other CYP2C9 inhibitors.

PMID: 30017171 [PubMed - as supplied by publisher]

Treatment of inherited bone marrow failure syndromes beyond transplantation.

Hematology Am Soc Hematol Educ Program. 2017 12 08;2017(1):96-101

Authors: Calado RT, Clé DV

Abstract
Despite significant progress in transplantation by the addition of alternative hematopoietic stem cell sources, many patients with inherited bone marrow failure syndromes are still not eligible for a transplant. In addition, the availability of sequencing panels has significantly improved diagnosis by identifying cryptic inherited cases. Androgens are the main nontransplant therapy for bone marrow failure in dyskeratosis congenita and Fanconi anemia, reaching responses in up to 80% of cases. Danazol and oxymetholone are more commonly used, but virilization and liver toxicity are major adverse events. Diamond-Blackfan anemia is commonly treated with corticosteroids, but most patients eventually become refractory to this treatment and toxicity is limiting. Growth factors still have a role in inherited cases, especially granulocyte colony-stimulating factor in congenital neutropenias. Novel therapies are warranted and thrombopoietin receptor agonists, leucine, quercetin, and novel gene therapy approaches may benefit inherited cases in the future.

PMID: 29222242 [PubMed - indexed for MEDLINE]

Dispensability of Annual Laboratory Follow-Up After More than 2 Years of Valproic Acid Use: A Systematic Review.

CNS Drugs. 2017 Nov;31(11):939-957

Authors: Meijboom RW, Grootens KP

Abstract
BACKGROUND: The necessity of annual laboratory follow-up in patients treated with valproic acid (VPA) is controversial.
OBJECTIVE: We investigated the need for annual laboratory follow-up of liver enzymes, electrolytes, and full blood count (FBC) in patients treated with VPA.
PATIENTS AND METHODS: A systematic search in Evidence-Based Medicine Reviews (EBMR), MEDLINE, and EMBASE was undertaken in December 2016 to identify all published articles investigating or citing valproic acid, liver function disorders, electrolyte disorders, and FBC deviations.
RESULTS: This review included 108 articles. As the number of participants and duration of the study was not adequate in most studies to detect rare adverse events, studies did not demonstrate a clear prevalence of hepatotoxicity. While a transient increase of transaminases is common and seldom harmful, severe hepatotoxicity is a rare phenomenon and is not prevented by routine laboratory monitoring. VPA had no relevant effect on serum calcium, sodium, potassium, and albumin. The prevalence of FBC varied from 0.6 to 27.8%, occurred mostly in the first 2 years of therapy, and was usually asymptomatic.
CONCLUSIONS: Long-term monitoring in VPA treatment is only necessary when there have been dose adjustments, co-medication switches, or co-morbidity. In uncomplicated cases, annual laboratory follow-up may be discontinued after 2 years of VPA treatment. Encouraging patients to be vigilant is more effective in the detection of hepatotoxicity than laboratory testing. Follow-up of FBC at 3-6 months, 1 year, and 2 years after start or after a dose increase of VPA or interacting medication is sufficient.

PMID: 29214384 [PubMed - indexed for MEDLINE]

Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

CNS Drugs. 2017 Nov;31(11):959-974

Authors: Kwok CS, Johnson EL, Krauss GL

Abstract
Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

PMID: 29204953 [PubMed - indexed for MEDLINE]

22 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 2018/07/18

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.

Acute Lidocaine Toxicity; a Case Series.

Emerg (Tehran). 2018;6(1):e38

Authors: Rahimi M, Elmi M, Hassanian-Moghaddam H, Zamani N, Soltaninejad K, Forouzanfar R, Shadnia S

Abstract
Introduction: Parenteral form of lidocaine is the best-known source of lidocaine poisoning. This study aimed to evaluate the characteristics of acute lidocaine toxicity .
Methods: In this retrospective cross-sectional study, demographics, clinical presentation, laboratory findings, and outcome of patients intoxicated with lidocaine (based on ICD10 codes) admitted to Loghman Hakim Hospital, during April 2007 to March 2014 were analyzed.
Results: 30 cases with the mean age of 21.83 ± 6.57 year were studied (60% male). All subjects had used either 6.5% lidocaine spray or 2% topical formulations of lidocaine. The mean consumed dose of lidocaine was 465 ± 318.17 milligrams. The most frequent clinical presentations were nausea and vomiting (50%), seizure (33.3%), and loss of consciousness (16.7%). 22 (73.3%) cases had normal sinus rhythm, 4 (13.3%) bradycardia, 2 (6.7%) ventricular tachycardia, and 2 (6.7%) had left axis deviation. 11 (36.6%) cases were intubated and admitted to intensive care unit (ICU) for 6.91 ± 7.16 days. Three patients experienced status epilepticus that led to cardiac arrest, and death (all cases with suicidal intention).
Conclusion: Based on the results of this study, most cases of topical lidocaine toxicity were among < 40-year-old patients with a male to female ratio of 1.2, with suicidal attempt in 90%, need for intensive care in 36.6%, and mortality rate of 10%.

PMID: 30009240 [PubMed]

Evaluation of preventable adverse drug reactions by implementation of the nationwide network of prospective drug utilization review program in Korea.

PLoS One. 2018;13(4):e0195434

Authors: Lee J, Noh Y, Lee S

Abstract
BACKGROUND: A prospective Drug Utilization Review (DUR) program has been implemented in Korea to improve the quality and safety of medication use.
OBJECTIVE: To evaluate the influence of the DUR program in reducing incidence of preventable adverse drug reactions (pADRs).
METHODS: This study was performed using administrative data from the Health Insurance Review and Assessment Service (HIRA). The claims data for all adult patients with adverse drug events (ADE)-related diagnoses from 2009 to 2014 were obtained. Incidence rates of first-time and repeat pADRs prior to and after DUR program implementation were evaluated. Quarterly trends in incidence rates of overall ADE, allergic reactions, and ADRs were analyzed.
RESULTS: Data extraction covering the period from 2009 to 2014 led to the identification of 3,927,662 records. First-time pADR rates decreased gradually after implementation of the DUR program (change in slope: -0.016, p = 0.02). The program had a similar influence on repeat pADR rates (change in slope: -0.006, p≤0.01). The program did not decrease rates of first-time or repeat allergic reactions (change in slope: 0.018, p = 0.07 and 0.003, p = 0.04, respectively). In the cohort aged ≤65 years, first-time pADR rate reduction was significant (28.2% [27.1-29.3] in ≤18 years, and 19.8% [18.1-21.5] in 19-64 years). In contrast, first-time pADR rate was increased by 0.6% [-0.7-1.9] in patients ≥65 years.
CONCLUSION: Implementation of the prospective DUR program effectively reduced the number of pADRs. In the future, to reduce non-preventable ADRs such as allergic reactions, provision of clinical information including allergy history should be added to the DUR program.

PMID: 29641617 [PubMed - indexed for MEDLINE]

Drug-related problems and changes in drug utilization after medication reviews in nursing homes in Oslo, Norway.

Scand J Prim Health Care. 2017 Dec;35(4):329-335

Authors: Fog AF, Kvalvaag G, Engedal K, Straand J

Abstract
OBJECTIVE: We describe the drug-related problems (DRPs) identified during medication reviews (MRs) and the changes in drug utilization after MRs at nursing homes in Oslo, Norway. We explored predictors for the observed changes.
DESIGN: Observational before-after study.
SETTING: Forty-one nursing homes.
INTERVENTION: MRs performed by multidisciplinary teams during November 2011 to February 2014.
SUBJECTS: In all, 2465 long-term care patients.
MAIN OUTCOME MEASURES: DRPs identified by explicit criteria (STOPP/START and NORGEP) and drug-drug interaction database; interventions to resolve DRPs; drug use changes after MR.
RESULTS: A total of 6158 DRPs were identified, an average of 2.6 DRPs/patient, 2.0 for regular and 0.6 for pro re nata (prn) drugs. Of these patients, 17.3% had no DRPs. The remaining 82.7% of the patients had on average 3.0 DRPs/patient. Use of unnecessary drugs (43.5%), excess dosing (12.5%) and lack of monitoring of the drug use (11%) were the most frequent DRPs. Opioids and psychotropic drugs were involved in 34.4% of all DRPs. The mean number of drugs decreased after the MR from 6.8 to 6.3 for regular drugs and from 3.0 to 2.6 for prn drugs. Patients with DRPs experienced a decrease of 1.1 drugs after MR (0.5 for regular and 0.6 for prn drugs). The reduction was most pronounced for the regular use of antipsychotics, antidepressants, hypnotics/sedatives, diuretics, antithrombotic agents, antacid drugs; and for prn use of anxiolytics, opioids, hypnotics/sedatives, metoclopramide and NSAIDs.
CONCLUSION: The medication review resulted in less drug use, especially opioids and psychotropic drugs.

PMID: 29096573 [PubMed - indexed for MEDLINE]

Drug-, herb- and dietary supplement-induced liver injury.

Arch Argent Pediatr. 2017 Dec 01;115(6):e397-e403

Authors: Cavalieri ML, D'Agostino D

Abstract
Drug- and substance-induced liver injury accounts for approximately 20% of pediatric cases of acute liver failure. It is caused by two mechanisms: direct and idiosyncratic hepatotoxicity. Direct hepatotoxicity is the result of the administration of a drug with intrinsic toxicity and is dose-dependent (e.g., acetaminophen). Idiosyncratic hepatotoxicity is unpredictable, uncommon, variable in presentation, and doseindependent. The clinical, histological, and laboratory manifestations include hepatitis, which is generally asymptomatic but with a significant increase of liver enzymes; cholestasis, accompanied with jaundice, pruritus, prominent elevation of alkaline phosphatase, and mild elevation of aminotransferases; or mixed, with elements of both hepatitis and cholestasis. Time to recovery is variable, depending on the type of liver injury. Early detection and discontinuation of the causative drug is the most effective and important step for the fast resolution of histological and clinical changes, thus reducing severe liver injury.

PMID: 29087122 [PubMed - indexed for MEDLINE]