13 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 2018/07/10

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.

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 2018/07/07

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.

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 2018/07/07

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.

Novel mandibular advancement bite block with supplemental oxygen to both nasal and oral cavity improves oxygenation during esophagogastroduodenoscopy: a bench comparison.

J Clin Monit Comput. 2018 Jul 04;:

Authors: Teng WN, Ting CK, Wang YT, Yang KY, Tsou MY, Orr JA, Burk KM, Chiang H, Lin CL

Abstract
Drug-induced respiratory depression is a major cause of serious adverse events. Adequate oxygenation is very important during sedated esophagogastroduodenoscopy (EGD). Nasal breathing often shifts to oral breathing during open mouth EGD. A mandibular advancement bite block was developed for EGD using computer-assisted design and three-dimensional printing techniques. The mandible is advanced when using this bite block to facilitate airway opening. The device is composed of an oxygen inlet with one opening directed towards the nostril and another opening directed towards the oral cavity. The aim of this bench study was to compare the inspired oxygen concentration (FiO2) provided by the different nasal cannulas, masks, and bite blocks commonly used in sedated EGD. A manikin head was connected to one side of a two-compartment lung model by a 7.0 mm endotracheal tube with its opening in the nasopharyngeal position. The other compartment was driven by a ventilator to mimic "patient" inspiratory effort. Using this spontaneously breathing lung model, we evaluated five nasal cannulas, two face masks, and four new oral bite blocks at different oxygen flow rates and different mouth opening sizes. The respiratory rate was set at 12/min with a tidal volume of 500 mL and 8/min with a tidal volume of 300 mL. Several Pneuflo resistors of different sizes were used in the mouth of the manikin head to generate different degrees of mouth opening. FiO2 was evaluated continuously via the endotracheal tube. All parameters were evaluated using a Datex anesthesia monitoring system. The mandibular advancement bite block provided the highest FiO2 under the same supplemental oxygen flow. The FiO2 was higher for devices with oxygen flow provided via an oral bite block than that provided via the nasal route. Under the same supplemental oxygen flow, the tidal volume and respiratory rate also played an important role in the FiO2. A low respiratory rate with a smaller tidal volume has a relative high FiO2. The ratio of nasal to oral breathing played an important role in the FiO2 under hypoventilation but less role under normal ventilation. Bite blocks deliver a higher FiO2 during EGD. The ratio of nasal to oral breathing, supplemental oxygen flow, tidal volume, and respiratory rate influenced the FiO2 in most of the supplemental oxygen devices tested, which are often used for conscious sedation in patients undergoing EGD and colonoscopy.

PMID: 29974302 [PubMed - as supplied by publisher]

Analyzing research trends on drug safety using topic modeling.

Expert Opin Drug Saf. 2018 Jun;17(6):629-636

Authors: Zou C

Abstract
INTRODUCTION: Published drug safety data has evolved in the past decade due to scientific and technological advances in the relevant research fields. Considering that a vast amount of scientific literature has been published in this area, it is not easy to identify the key information. Topic modeling has emerged as a powerful tool to extract meaningful information from a large volume of unstructured texts. Areas covered: We analyzed the titles and abstracts of 4347 articles in four journals dedicated to drug safety from 2007 to 2016. We applied Latent Dirichlet allocation (LDA) model to extract 50 main topics, and conducted trend analysis to explore the temporal popularity of these topics over years. Expert Opinion/Commentary: We found that 'benefit-risk assessment and communication', 'diabetes' and 'biologic therapy for autoimmune diseases' are the top 3 most published topics. The topics relevant to the use of electronic health records/observational data for safety surveillance are becoming increasingly popular over time. Meanwhile, there is a slight decrease in research on signal detection based on spontaneous reporting, although spontaneous reporting still plays an important role in benefit-risk assessment. The topics related to medical conditions and treatment showed highly dynamic patterns over time.

PMID: 29621918 [PubMed - indexed for MEDLINE]

Deprescribing antihyperglycemic agents in older persons: Evidence-based clinical practice guideline.

Can Fam Physician. 2017 Nov;63(11):832-843

Authors: Farrell B, Black C, Thompson W, McCarthy L, Rojas-Fernandez C, Lochnan H, Shamji S, Upshur R, Bouchard M, Welch V

Abstract
OBJECTIVE: To develop an evidence-based guideline to help clinicians make decisions about when and how to safely taper, stop, or switch antihyperglycemic agents in older adults.
METHODS: We focused on the highest level of evidence available and sought input from primary care professionals in guideline development, review, and endorsement processes. Seven clinicians (2 family physicians, 3 pharmacists, 1 nurse practitioner, and 1 endocrinologist) and a methodologist comprised the overall team; members disclosed conflicts of interest. We used a rigorous process, including the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach, for guideline development. We conducted a systematic review to assess evidence for the benefits and harms of deprescribing antihyperglycemic agents. We performed a review of reviews of the harms of continued antihyperglycemic medication use, and narrative syntheses of patient preferences and resource implications. We used these syntheses and GRADE quality-of-evidence ratings to generate recommendations. The team refined guideline content and recommendation wording through consensus and synthesized clinical considerations to address common front-line clinician questions. The draft guideline was distributed to clinicians and stakeholders for review and revisions were made at each stage. A decision-support algorithm was developed to accompany the guideline.
RECOMMENDATIONS: We recommend deprescribing antihyperglycemic medications known to contribute to hypoglycemia in older adults at risk or in situations where antihyperglycemic medications might be causing other adverse effects, and individualizing targets and deprescribing accordingly for those who are frail, have dementia, or have a limited life expectancy.
CONCLUSION: This guideline provides practical recommendations for making decisions about deprescribing antihyperglycemic agents. Recommendations are meant to assist with, not dictate, decision making in conjunction with patients.

PMID: 29138153 [PubMed - indexed for MEDLINE]

Occurrence of Multiple Sclerosis After Drug Exposure: Insights From Evidence Mapping.

Drug Saf. 2017 Sep;40(9):823-834

Authors: Antonazzo IC, Raschi E, Vignatelli L, Baldin E, Riise T, D'Alessandro R, De Ponti F, Poluzzi E

Abstract
INTRODUCTION: The role of drugs in the occurrence of multiple sclerosis (MS) is perceived to be insufficiently investigated.
OBJECTIVE: The aim of this study was to map and assess the evidence on MS occurrence after drug exposure, in order to identify possible signals of causal association.
METHODS: A search strategy was performed in MEDLINE and Embase as of July 2016; references consistent with the aim of the study were analysed to extract relevant measures of causal association between drugs and MS. The Newcastle-Ottawa Scale and appropriate guidelines from the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) were used to assess the quality of included studies.
RESULTS: After screening 832 articles, 58 were selected (of which 14 were found by checking the reference lists of reviews): 30 case reports and case series, 24 longitudinal studies and four randomized controlled trials. Seven longitudinal studies had good (at least 7 out of 9) quality scores, whereas case reports/case series presented several limitations. Half of included articles focused on immunomodulatory drugs (etanercept, infliximab and adalimumab), especially in case reports/series, suggesting an association with MS occurrence. Contraceptives and antibacterials were investigated in some population-based studies, without definite results.
CONCLUSION: A heterogeneous pharmacological profile of identified classes emerged. Low strength of evidence and conflicting results highlighted the difficulties in addressing the possible contribution of drugs in MS occurrence. Methodological advances are needed, especially to control the confounding role of underlying disease for specific drug classes.

PMID: 28597251 [PubMed - indexed for MEDLINE]

An Algorithm to Identify Generic Drugs in the FDA Adverse Event Reporting System.

Drug Saf. 2017 Sep;40(9):799-808

Authors: Iyer G, Marimuthu SP, Segal JB, Singh S

Abstract
INTRODUCTION: Although generic drugs constitute approximately 88% of drugs prescribed in the US, there are no reliable methods to identify generic drugs in the US FDA Adverse Event Reporting System (FAERS).
OBJECTIVE: The aim of this study was to develop an algorithm for identifying generic drugs in the FAERS.
DATA SOURCE: We used 1237 adverse event reports for tamsulosin, levothyroxine, and amphetamine/dextroamphetamine from the publicly available FAERS from 2011-2013, and 277 source case narratives obtained from the FDA.
METHODS: Two reviewers independently and in duplicate used a three-item algorithm including the following criteria: manufacturer name, New Drug Application (NDA) number/abbreviated NDA (ANDA), and specific use of the term 'generic' or 'brand' to classify the focal drug of each case report as definitely generic (two of three criteria), probably generic (one of three criteria), brand, and cannot be assessed. Inter-rater reliability was estimated using kappa coefficients, and internal consistency was estimated using Cronbach's alpha. We compared the classification of the drugs as generic versus non-generic in publicly available FAERS compared with the original case reports (reference).
RESULTS: The focal drug was classified as generic (definite or probable) in 15.8% (39/234), 9% (67/742), and 16.7% (42/261) of tamsulosin, levothyroxine and amphetamine/dextroamphetamine cases, respectively (overall kappa 0.89, 95% confidence interval 0.85-0.93), while 37% of reports could not be classified due to incomplete information. Among the drugs classified as generics using the publicly available FAERS, we categorized 95.3% as generic drugs using the original case reports. Among those drugs that did not meet the algorithm-based definition of generic in the publicly available data, 20.9% were reclassified as generics using the original case reports.
CONCLUSIONS: The algorithm demonstrated high inter-rater reliability with moderate internal consistency for identifying generic drugs in the FAERS, in our sample. Future efforts should focus on improving the reliability and validity of identifying generics through improving the completeness of reporting in the FAERS.

PMID: 28593504 [PubMed - indexed for MEDLINE]

Role of Medicines of Unknown Identity in Adverse Drug Reaction-Related Hospitalizations in Developing Countries: Evidence from a Cross-Sectional Study in a Teaching Hospital in the Lao People's Democratic Republic.

Drug Saf. 2017 Sep;40(9):809-821

Authors: Caillet C, Sichanh C, Assemat G, Malet-Martino M, Sommet A, Bagheri H, Sengxeu N, Mongkhonmath N, Mayxay M, Syhakhang L, Lapeyre-Mestre M, Newton PN, Roussin A

Abstract
INTRODUCTION: The health dangers of medicines of unknown identity (MUIs) [loose pharmaceutical units repackaged in individual bags without labelling of their identity] have been suspected in L/MICs. Using visual and analytical tools to identify MUIs, we investigated the frequency of, and factors associated with, adverse drug reaction (ADR)-related hospitalizations in a central hospital in Vientiane Capital, Lao People's Democratic Republic (PDR).
METHODS: All unplanned admissions, except for acute trauma and intentional overdose, were prospectively recorded during a 7-week period in 2013, leading to include 453 adults hospitalized for ≥24 h. The patients or their relatives were interviewed to complete the study questionnaire. MUIs suspected of being involved in ADR(s) were identified through comparison of visual characteristics of tablets/capsules with that of reference medicines (photograph tool), and by proton nuclear magnetic resonance and mass spectrometry analyses. Factors associated with ADRs were identified by multivariate logistic regression.
RESULTS: The frequency of hospitalizations related to an ADR was 5.1% (23/453, 95% confidence interval [CI] 3.1-7.1). Forty-eight (12.8%) patients used MUI(s) in the last 2 weeks preceding hospitalization. They were more likely to be hospitalized because of an ADR (adjusted odds ratio 4.5, 95% CI 1.7-11.5) than patients using medicines of known identity. MUIs were mainly involved in bleeding gastroduodenal ulcers. The photograph tool led to the misidentifications because of look-alike pharmaceutical units in the medicines photograph collection.
CONCLUSION: According to the results of this study, there is a need to ensure appropriate labelling of medicines at dispensing and to provide well-suited tools to identify MUIs in clinical settings to improve drug safety and patients' care in developing countries with limited capacities for drug analysis.

PMID: 28528487 [PubMed - indexed for MEDLINE]

Evaluation of the Case-Crossover (CCO) Study Design for Adverse Drug Event Detection.

Drug Saf. 2017 Sep;40(9):789-798

Authors: Burningham Z, He T, Teng CC, Zhou X, Nebeker J, Sauer BC

Abstract
INTRODUCTION: The case-crossover (CCO) design was originally intended to study exposures characterized as intermittent with acute effects. The performance of the CCO design is not well characterized under alternative exposure and outcome relationships.
OBJECTIVE: The purpose of this study was to evaluate the ability of the CCO to identify simulated treatment effects under different drug exposures and outcomes relationships while varying the duration of the 1:1 matched risk and control windows.
METHODS: The simulated data were obtained from the Observational Medical Dataset Simulator, version 2 (OSIM2). The area under the receiver operator characteristic curve (AUC) was calculated to compare CCO performance across outcome types, simulated relative risk (RR), and duration of risk and control windows.
RESULTS: The AUC for acute outcomes was higher for shorter risk and control windows and improved with higher simulated RR. For example, the AUC for the simulated RR of 4 was 0.95 for a 30-day window length and 0.78 for a 360-day window length. The AUC for the accumulative outcomes increased with longer risk and control windows and stronger simulated RR. For example, the AUC for the simulated RR of 4 was 0.85 for a 360-day window length and 0.23 for a 30-day window length. Risk and control window lengths did not appear to sufficiently alter the AUC for insidious onset outcomes.
CONCLUSIONS: The CCO performed best for acute-onset outcomes, but may be useful for exploring adverse outcomes with accumulative effects. Careful consideration must be given to the hypothesized drug exposure and outcome distribution because specification of risk and control window duration affects CCO performance.

PMID: 28474287 [PubMed - indexed for MEDLINE]

Agreement between renal prescribing references and determination of prescribing appropriateness in hospitalized patients with chronic kidney disease.

QJM. 2017 Oct 01;110(10):623-628

Authors: O'Shaughnessy M, Allen N, O'Regan J, Payne-Danson E, Mentre L, Davin D, Lavin P, Grimes T

Abstract
Background: Chronic kidney disease (CKD) is a risk factor for adverse drug events. The clinical significance of discordance between renal prescribing references is unknown.
Aim: We determined the prevalence of potentially inappropriate prescribing (PIP) in CKD, measured agreement between two prescribing references, and assessed potential for harm consequent to PIP.
Design: Single-centre observational study.
Methods: A random sample of hospitalized patients with CKD were grouped according to baseline CKD stage (3, 4, or 5). Prescriptions requiring caution in CKD were referenced against the Renal Drug Handbook (RDH) and British National Formulary (BNF) to identify PIP (non-compliance with recommendations). Inter-reference agreement was measured using percentage agreement and Kappa coefficient. Potential for harm consequent to PIP was assessed by physicians and pharmacists using a validated scale. One-year mortality was compared between patients with or without PIP during admission.
Results: Among 119 patients (median age 73 years, 50% male), 136 cases of PIP were identified in 78 (65.5%) patients. PIP prevalence, per patient, was 64.7% using the BNF and 28.6% using the RDH (fair agreement, Kappa 0.33, P <  0.001). The majority (63.2%) of PIP cases detected exclusively by the BNF carried minimal or no potential for harm. PIP was not significantly associated with one-year mortality (34.7% vs. 21.1%, P = 0.14).
Conclusions: PIP was common in hospitalized patients with CKD. Substantial discordance between renal prescribing references was apparent. The development of universally-adopted, evidence-based, prescribing guidelines for CKD might optimize medications safety in this vulnerable group.

PMID: 28431157 [PubMed - indexed for MEDLINE]

A non-fatal intoxication and seven deaths involving the dissociative drug 3-MeO-PCP.

Forensic Sci Int. 2017 Jun;275:76-82

Authors: Johansson A, Lindstedt D, Roman M, Thelander G, Nielsen EI, Lennborn U, Sandler H, Rubertsson S, Ahlner J, Kronstrand R, Kugelberg FC

Abstract
INTRODUCTION: 3-methoxyphencyclidine (3-MeO-PCP) appeared on the illicit drug market in 2011 and is an analogue of phencyclidine, which exhibits anesthetic, analgesic and hallucinogenic properties. In this paper, we report data from a non-fatal intoxication and seven deaths involving 3-MeO-PCP in Sweden during the period March 2014 until June 2016.
CASE DESCRIPTIONS: The non-fatal intoxication case, a 19-year-old male with drug problems and a medical history of depression, was found awake but tachycardic, hypertensive, tachypnoeic and catatonic at home. After being hospitalized, his condition worsened as he developed a fever and lactic acidosis concomitant with psychomotor agitation and hallucinations. After 22h of intensive care, the patient had made a complete recovery. During his hospitalization, a total of four blood samples were collected at different time points. The seven autopsy cases, six males and one female, were all in their twenties to thirties with psychiatric problems and/or an ongoing drug abuse.
METHODS: 3-MeO-PCP was identified with liquid chromatography (LC)/time-of-flight technology and quantified using LC-tandem mass spectrometry.
RESULTS: In the clinical case, the concentration of 3-MeO-PCP was 0.14μg/g at admission, 0.08μg/g 2.5h after admission, 0.06μg/g 5h after admission and 0.04μg/g 17h after admission. The half-life of 3-MeO-PCP was estimated to 11h. In the autopsy cases, femoral blood concentrations ranged from 0.05μg/g to 0.38μg/g. 3-MeO-PCP was the sole finding in the case with the highest concentration and the cause of death was established as intoxication with 3-MeO-PCP. In the remaining six autopsy cases, other medications and drugs of abuse were present as well.
CONCLUSION: Despite being scheduled in January 2015, 3-MeO-PCP continues to be abused in Sweden. Exposure to 3-MeO-PCP may cause severe adverse events and even death, especially if the user does not receive life-supporting treatment.

PMID: 28324770 [PubMed - indexed for MEDLINE]

Autoimmune Hepatitis in the Elderly: Diagnosis and Pharmacologic Management.

Drugs Aging. 2018 Jul 04;:

Authors: Rizvi S, Gawrieh S

Abstract
Autoimmune hepatitis (AIH) may present as acute or chronic hepatitis in the elderly. Advanced hepatic fibrosis and cirrhosis are common on first presentation in this population. In this review, we discuss the presentation, approach to diagnosis and management of AIH in the elderly. As polypharmacy is common in the elderly, careful medication use history is essential for detecting drug-induced AIH-like hepatitis. Steroid-sparing or minimizing therapeutic regimens are preferred to treat AIH in the elderly. For the purpose of induction, budesonide or lower dose prednisone in combination with azathioprine (AZA) regimens are preferred over high-dose prednisone monotherapy due to the higher risk of side effects of the later in the elderly. The goal of maintenance therapy should be to achieve full biochemical and histologic remission. Bone density monitoring and interventions to prevent steroid-related bone disease should be implemented throughout the course of the disease. Liver transplantation should be considered in the elderly patient with liver failure or early hepatocellular carcinoma if there are no significant comorbidities or compromise in functional status.

PMID: 29971609 [PubMed - as supplied by publisher]

Safety and immune response after two-dose meningococcal C conjugate immunization in HIV-infected children and adolescents in Rio de Janeiro, Brazil.

Vaccine. 2017 12 15;35(50):7042-7048

Authors: Frota ACC, Ferreira B, Harrison LH, Pereira GS, Pereira-Manfro W, Machado ES, de Oliveira RH, Abreu TF, Milagres LG, Hofer CB

Abstract
We aimed to evaluate immunogenicity and adverse events (AEs) after a booster dose of Meningococcal C conjugated (MCC) vaccine in HIV-infected children and adolescents, who had a previous low seroconversion rate after priming with MCC, at a reference HIV-care center in Rio de Janeiro.
METHODS: 2-18 years old HIV-infected subjects with CD4+ T-lymphocyte cell (CD4) ≥15%, without active infection or antibiotic use, were enrolled to receive 2 doses of conjugated meningococcal C oligosaccharide-CRM197 12-18 months apart. All patients were evaluated before and 1-2 months after immunization for seroprotection [defined as human serum bactericidal activity (hSBA) titer ≥1:4]. AEs were assessed at 20 min, 3 and 7 days after each dose. Factors independently associated with seroprotection were studied.
RESULTS: 156 subjects were enrolled and 137 received a booster MCC dose. 55% were female, and median age was 12 years. Eight-nine percent were receiving combined antiretroviral therapy (cART) at the booster visit (median duration of 7.7 years), 59.9% had undetectable viral load (VL) at baseline, and 56.2% at the booster visit. Seroprotection was achieved in 78.8% (108/137) subjects, with a significantly higher GMT than after the priming dose (p < 0.01). Mild AEs were experienced after a second MCC dose (38%). In logistic regression, undetectable viral load at entry [odds ratio (OR) = 7.1, 95% confidence interval (95%CI): 2.14-23.37], and probably higher CD4 percent at the booster immunization visit (OR): 1.1, 95%CI: 1.01-1.17 were associated with seroprotection after a booster dose of MCC.
CONCLUSION: A booster dose of MCC was safe and induced high seroprotection rate even 12-18 months after priming. MCC should be administered after maximum virologic suppression has been achieved. These results support the recommendation of 2-dose of MCC for primary immunization in HIV-infected children and adolescents with restored immune function.

PMID: 29100708 [PubMed - indexed for MEDLINE]

A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging.

Vaccine. 2017 12 15;35(50):6941-6948

Authors: Stockwell MS, Marchant CD, Wodi AP, Barnett ED, Broder KR, Jakob K, Lewis P, Kattan M, Rezendes AM, Barrett A, Sharma D, Fernandez N, LaRussa P

Abstract
BACKGROUND: Using text messaging for vaccine safety monitoring, particularly for non-medically attended events, would be valuable for pandemic influenza and emergency vaccination program preparedness. We assessed the feasibility and acceptability of text messaging to evaluate fever and wheezing post-influenza vaccination in a prospective, observational, multi-site pediatric study.
METHODS: Children aged 2-11 years old, with an emphasis on children with asthma, were recruited during the 2014-2015 influenza season from three community-based clinics in New York City, and during the 2014-2015 and 2015-2016 seasons from a private practice in Fall River, Massachusetts. Parents of enrolled children receiving quadrivalent live attenuated (LAIV4) or inactivated influenza vaccine (IIV4) replied to text messages assessing respiratory symptoms (day 3 and 7, then weekly through day 42), and temperature on the night of vaccination and the next seven nights (day 0-7). Missing data were collected via diary (day 0-7 only) and phone. Phone confirmation was obtained for both presence and absence of respiratory symptoms. Reporting rates, fever (T≥100.4 °F) frequency, proportion of wheezing and/or chest tightness reports captured via text message versus all sources (text, phone, diary, electronic health record) and parental satisfaction were assessed.
RESULTS: Across both seasons, 266 children were analyzed; 49.2% with asthma. Parental text message response rates were high (>70%) across sites. Overall, fever frequency was low (day 0-2: 4.1% [95% confidence interval (CI) 2.3-7.4%]; d3-7: 6.7% [95% CI 4.1-10.8%]). A third (39.2%) of parents reported a respiratory problem in their child, primarily cough. Most (88.2%) of the 52 wheezing and/or chest tightness reports were by text message. Most (88.1%) participants preferred text messaging over paper reporting.
CONCLUSIONS: Text messaging can provide information about pediatric post-vaccination fever and wheezing and was viewed positively by parents. It could be a helpful tool for rapid vaccine safety monitoring during a pandemic or other emergency vaccination program.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02295007.

PMID: 29089191 [PubMed - indexed for MEDLINE]

Immediate hypersensitivity to penicillins. Identification of a new antigenic determinant.

J Pharm Biomed Anal. 2018 Jan 30;148:17-23

Authors: Matas S, Broto M, Corominas M, Lleonart R, Babington R, Marco MP, Galve R

Abstract
The study of adverse drug reactions (ADRs) constitutes a challenge in the area of Medicine. Drugs generate a large number of the total registered hypersensitivity reactions, where penicillins are responsible for more than half of them. In vitro tests in the market are not efficient enough since they lack in sensitivity and specificity. This is the reason why in vivo tests are carried out, with the subsequent danger to the patient's life. It is essential to discover new β-lactam antigenic determinants to develop more effective detection systems and thus, obtain better explanations of the allergic mechanisms related to these drugs. We propose a strategy based on the use of "peptide probes", small labeled and chemical active peptides which have been structurally modified for reacting with the β-lactam moiety at different conditions. The probes also contain a biotin group for application in an immunoassay format. Three different amoxicillin adducts have been obtained, purified and characterized by HPLC-MS and NMR techniques. These results have helped us to elucidate and propose a new antigenic determinant for β-lactams, named the "penamidyl" epitope. All the adducts have been validated and evaluated with sera from different penicillin allergic patients by means of a Magneto-ELISA, immunochemical technique that has allowed us to detect specific IgEs in a very high percentage of the serum samples. An immunoassay has been developed, validated and applied as a diagnostic tool for the detection of specific IgEs in the sera of penicillin allergic patients using a new antigenic determinant.

PMID: 28987997 [PubMed - indexed for MEDLINE]

Prescribing cascade. A proposed new way to evaluate it.

Medicina (B Aires). 2017;77(1):13-16

Authors: Ponte ML, Wachs L, Wachs A, Serra HA

Abstract
Prescribing cascade is defined as the situation in which a first drug administered to a patient causes adverse event signs and symptoms, that are misinterpreted as a new condition, resulting in a new medication being prescribed. The cascade may have multiple steps and differ in complexity and severity. Despite being well identified, prescribing cascade is an increasingly common problem in medical practice. It constitutes a warning about irrational use of medicines that puts health at risk and increases treatment costs if it is not taken into account. In this article, representative cases taken from Hospital General de Agudos Dr. Cosme Argerich pharmacovigilance database were selected to assess a proper score and an algorithm that define the probable prescribing cascade.

PMID: 28140305 [PubMed - indexed for MEDLINE]

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 2018/07/03

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.

The Hemodynamic Effects of Intracavernosal Phenylephrine for the Treatment of Ischemic Priapism.

J Sex Med. 2018 Jul;15(7):990-996

Authors: Sidhu AS, Wayne GF, Kim BJ, Anderson AGS, Cordon BH, Caso JR, Polackwich AS

Abstract
AIM: We sought to evaluate whether the administration of phenylephrine (PE) at concentrations higher than those described in guidelines resulted in any significant changes in vital signs or impacted outcomes.
METHODS: After receiving institutional review board approval, we retrospectively reviewed the charts of patients presenting to our emergency department between May 1, 2014, and August 15, 2016, using International Classification of Diseases, Ninth Edition and Internation Classification of Disease, Tenth Edition diagnosis codes for priapism. Treatment was reviewed, including corporal aspiration/irrigation, injection of PE, and shunt procedures. Vital signs were compared before and after treatment with PE. Baseline variables were explored with categorical data analysis (chi-squared tests, t-tests, and Mann-Whitney nonparametric tests). Where feasible, linear regression was used to evaluate outcomes.
MAIN OUTCOME MEASURE: Detumescence and changes in blood pressure and heart rate.
RESULTS: We identified 74 different patient encounters of acute priapism. The median age was 36.5 years (interquartile range [IQR] = 27-47), and the median time to presentation was 5.4 hours (IQR = 4.0-9.6). 62 percent of cases were due to drug-induced priapism. In 58 (74%) encounters, patients received PE. The median dose of PE given was 1000 μg (IQR 500-2,000). Univariate regression found no association between PE dose and change in patient heart rate or blood pressure. A statistically significant decrease in heart rate (HR) (-4.2 BPM), systolic blood pressure (BP) (-1.8 mm Hg), and diastolic BP (-5.4 mm Hg) was noted. Fifty-three of 58 (91%) patients receiving PE experienced detumescence at the bedside, 2 required shunting in operating room, and 3 refused treatment and left against medical advice. No adverse events occurred.
CONCLUSION: We frequently treat patients with high doses of PE and seldom notice adverse effects, typically resulting in resolution of priapism without any additional procedures. Careful administration of high doses of intracavernosal PE in patients presenting with priapism does not appear to significantly affect heart rate or blood pressure and may help prevent further ischemic damage and achieve detumescence effectively and efficiently. Sidhu AS, Wayne GF, Kim BJ, et al. The hemodynamic effects of intracavernosal phenylephrine for the treatment of ischemic priapism. J Sex Med 2018;15:990-996.

PMID: 29960632 [PubMed - in process]

Glycoprotein IIb/IIIa receptor imaging with 18F-GP1 positron emission tomography for acute venous thromboembolism: an open-label, non-randomized, first-in-human phase 1 study.

J Nucl Med. 2018 Jun 29;:

Authors: Kim C, Lee JS, Han Y, Chae SY, Jin S, Sung C, Son HJ, Oh SJ, Lee SJ, Oh JS, Cho YP, Kwon TW, Lee DH, Jang S, Kim B, Koglin N, Berndt M, Stephens AW, Moon DH

Abstract
18F-GP1 is a derivative of elarofiban with a high affinity to activated platelet glycoprotein IIb/IIIa (GPIIb/IIIa) and favorable in vivo characteristics for thrombus imaging in preclinical models. We aimed to explore the detection rate of thromboembolic foci with 18F-GP1 positron emission tomography/computed tomography (PET/CT) in patients with acute venous thromboembolism (VTE), and to evaluate the safety, biodistribution, pharmacokinetics, and metabolism of 18F-GP1. Methods: We studied patients who had signs or symptoms of acute deep vein thrombosis (DVT) of the leg or acute pulmonary embolism (PE) within 14 days prior to 18F-GP1 PET/CT, and had thromboembolic foci confirmed by conventional imaging (n = 10 for DVT and n = 10 for PE). Dynamic whole-body PET/CT images were acquired for up to 140 minutes after injection of 250 MBq of 18F-GP1. Results:18F-GP1 PET/CT was well tolerated without any drug-related adverse events, and showed high initial uptake in spleen, kidney, and blood pool, followed by rapid clearance. The overall image quality was excellent and allowed interpretation in all patients. 18F-GP1 PET/CT identified thromboembolic foci in all 20 patients with either DVT or PE. Vessel-level analysis revealed that 18F-GP1 PET/CT detected 89% (68/76) of vessels with DVT, and 60% (146/245) for PE. Importantly, 18F-GP1 PET/CT showed increased uptake in 32 vessels that were not detected by conventional imaging, of which 25 were located in distal veins of the lower extremity in 12 patients. A positive correlation was found between 18F-GP1 uptake and P-selectin-positive circulating platelets (r = 0.656, P = 0.002). Conclusion:18F-GP1 is a promising PET tracer for imaging acute VTE in patients. 18F-GP1 PET/CT may identify thrombi in distal veins of the leg, where conventional imaging has limitations.

PMID: 29959214 [PubMed - as supplied by publisher]