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 2019/06/25

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.

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 2019/06/22

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.

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 2019/06/22

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.

20 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 2019/06/21

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.

20 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 2019/06/21

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.

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 2019/06/20

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.

Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.

Pharmacoepidemiol Drug Saf. 2019 Jun 17;:

Authors: Denig P, van Puijenbroek EP, Soliman N, Mol PGM, de Vries ST

Abstract
PURPOSE: Little is known about adverse drug events (ADEs) experienced over time during chronic drug use. The purpose of this study was to assess ADE patterns experienced by patients with diabetes.
METHODS: Patients who received an oral glucose-lowering drug completed a daily diary for 13 weeks. The diary asked for experienced symptoms and whether patients related these symptoms to any drug they used. Summaries of Product Characteristics were used to check whether the ADEs were known adverse drug reactions (ADRs) of the drugs used. Patterns of weekly occurring ADEs were assessed with descriptive statistics.
RESULTS: We included 78 patients. Almost half of them reported at least one ADE (N = 36; 46%). In total, 80 ADEs were reported. Of these ADEs, 71 (90%) were known ADRs. ADEs lasted less than 1 week in 27 cases (34%) and between 2 and 12 weeks in 15 cases (19%). The remaining ADEs fluctuated (16 cases; 20%) or persisted (22 cases; 28%) during the entire study period.
CONCLUSIONS: ADEs experienced by patients with diabetes can fluctuate or persist over long periods of drug use.

PMID: 31209934 [PubMed - as supplied by publisher]

Elevated neutrophil to lymphocyte ratio as an indicator of secondary erythema nodosum, a retrospective observational study

Turk J Med Sci. 2019 Apr 18;49(2):624-634

Authors: Hayran Y, Öktem A, Şahin B, İncel Uysal P, Allı N, Yalçın B

Abstract
Background/aim: Erythema nodosum (EN) is an inflammatory disorder of subcutaneous tissue. Although etiopathogenesis of the disease is unknown, many predisposing factors such as infections, systemic disease, and drugs have been identified. Neutrophil to lymphocyte ratio (NLR) has been shown to be a novel inflammatory marker in many dermatological diseases. The aim of our study is to investigate NLR in EN patients and evaluate its relation to the underlying cause of the disease.
Materials and methods: Between 2014 and 2018, clinical and laboratory data of 395 patients diagnosed with EN and 395 controls were extracted from patient files. EN patients were grouped as idiopathic EN and secondary EN (EN with an identified underlying cause). Clinical and laboratory characteristics of the two groups were compared
Results: NLR was elevated in EN patients compared to controls (median of 2.38 vs. 1.55, P < 0.001). Among EN patients, NLR was also elevated in patients with secondary EN. In multivariate logistic regression model NLR (> 2.11), RDW-CV (> 13.65), and CRP (> 5.5) were identified as risk factors for secondary EN (relative risks were 17.16, 2.69, and 2, respectively).
Conclusion: Elevated NLR (> 2.11) may be used as a parameter to discriminate secondary EN from idiopathic EN.

PMID: 30997978 [PubMed - indexed for MEDLINE]

The use of oral fosfomycin-trometamol in patients with catheter-associated urinary tract infections (CAUTI): new indications for an old antibiotic?

J Chemother. 2018 Sep;30(5):290-295

Authors: Cai T, Cocci A, Verze P, Rizzo M, Palmieri A, Liguori G, Trombetta C, Adembri C, Carini M, Bartoletti R, Wagenlehner FM, Bonkat G, Mirone V, Bjerklund Johansen TE, Novelli A

Abstract
We present the results of a multicenter retrospective study of 35 difficult-to-treat patients with urinary tract infections associated with indwelling urinary catheters (CAUTIs). All patients received oral administration of 3 g fosfomycin trometamol once a day for two days and then with a dose of 3 g every 48 h for two weeks. The most commonly isolated strains were: Escherichia coli (65.7%) and Enterococcus spp. (25.7%); prevalence of Extended-Spectrum Beta-Lactamase strains was 48.5%. Six patients (17.1%) had a clinical response after a single dose of fosfomycin trometamol, 12 (34.2%) after two doses and 13 (37.1%) patients had a clinical response after three or more doses. Four patients (11.6%) failed prolonged antibiotic treatment with fosfomycin trometamol. During the follow-up period, 30 out of 35 (85.7%) patients were without symptomatic infections. No significant side effects were reported. In conclusion, fosfomycin trometamol seems to be a valid treatment option in patients with CAUTIs.

PMID: 30843774 [PubMed - indexed for MEDLINE]

Intestinal dysbiosis compromises alveolar macrophage immunity to Mycobacterium tuberculosis.

Mucosal Immunol. 2019 05;12(3):772-783

Authors: Khan N, Mendonca L, Dhariwal A, Fontes G, Menzies D, Xia J, Divangahi M, King IL

Abstract
Current treatments for tuberculosis (TB) are effective in controlling Mycobacterium tuberculosis (Mtb) growth, yet have significant side effects and do not prevent reinfection. Therefore, it is critical to understand why our host defense system is unable to generate permanent immunity to Mtb despite prolonged anti-tuberculosis therapy (ATT). Here, we demonstrate that treatment of mice with the most widely used anti-TB drugs, rifampicin (RIF) or isoniazid (INH) and pyrazinamide (PYZ), significantly altered the composition of the gut microbiota. Unexpectedly, treatment of mice with the pro-Mtb drugs INH and PYZ, but not RIF, prior to Mtb infection resulted in an increased bacterial burden, an effect that was reversible by fecal transplantation from untreated animals. Mechanistically, susceptibility of INH/PYZ-treated mice was associated with impaired metabolism of alveolar macrophages and defective bactericidal activity. Collectively, these data indicate that dysbiosis induced by ATT administered to millions of individuals worldwide may have adverse effects on the anti-Mtb response of alveolar macrophages.

PMID: 30783183 [PubMed - indexed for MEDLINE]

[Medications in breastfeeding: what evidence is there?]

Cien Saude Colet. 2019 Feb;24(2):573-587

Authors: Raminelli M, Hahn SR

Abstract
Breastfeeding plays a fundamental role in the benefits for the health of the newborn child and the nursing mother. The use of medications during breastfeeding is a relevant issue, by virtue of the frequent need for pharmacological treatment in the postpartum period. The scope of this article was to conduct a review of the literature regarding the efficacy and safety of medications used during the breastfeeding period. A search was conducted in the PubMed (National Library of Medicine), ScienceDirect and Biblioteca Virtual em Saúde (BVS) databases for articles published in Portuguese, English and Spanish in the period from 1981 to 2016. This review discusses the risk of the use of medications during lactation and the effects that they may have on the breastfed infant. Few medications are contraindicated and others require care due the risk of adverse effects on breastfed infants or in the suppression of breast milk volume. Therefore, the dissemination of updated information for the health professional to adequately assess the risks and the benefits of the use of medications during breastfeeding is of vital importance, thereby contributing to avoid early weaning.

PMID: 30726389 [PubMed - indexed for MEDLINE]

Clinical tools for chemotherapy toxicity prediction and survival in geriatric cancer patients.

J Chemother. 2018 Sep;30(5):266-279

Authors: Voutsadakis IA

Abstract
Chemotherapy is one of the main treatments for cancer and is associated in many cancers with significant benefits in overall and disease-free survival. Nevertheless, it is also associated with adverse effects that make its administration difficult in patients with comorbidities or decreased general status. Older patients belong more often to these categories because of the physiologic effects of aging in organ functions but also because of longer effects of chronic conditions in different organs. As a result, the decision for administration of possibly beneficial chemotherapy to older patients becomes more problematic given that there is a requirement to balance this benefit with a higher probability of severe adverse effects that may even culminate to patient's demise. Thus, the ability to predict accurately the subset of older patients that will develop severe adverse effects with chemotherapy and, conversely, those that will tolerate it with a more acceptable adverse effect profile, is of clinical importance. This article will discuss progress made in devising predictive tools for use in older patients with cancer considered for receiving chemotherapy. A discussion of recent developments on the related but distinct subject of prediction of mortality in geriatric cancer patients with a focus on those receiving chemotherapy will also be included to provide a data-frame of the status of survival prediction tools in geriatric oncology patients.

PMID: 29943680 [PubMed - indexed for MEDLINE]

NASH in Nondiabetic Endocrine Disorders.

Metab Syndr Relat Disord. 2018 09;16(7):315-320

Authors: Wang T, Yang W, Karakas S, Sarkar S

Abstract
Nonalcoholic fatty liver disease (NAFLD) encompasses a spectrum of disease, including hepatic steatosis, inflammation, and fibrosis. NAFLD carries the risk of progression to cirrhosis with its associated complications and hepatocellular carcinoma. It is now the most common liver disease in the Western world and its prevalence is increasing. While the association between NAFLD and type 2 diabetes has been well documented, there is significantly less understanding of the pathophysiology and progression of NAFLD in patients with other endocrine disorders affecting metabolism in various ways. Some of the more common endocrine disorders such as polycystic ovarian syndrome, growth hormone deficiency, hypothyroidism, and hypogonadism are known in clinical practice to be associated with NAFLD. Medications that alter the endocrine system such as tamoxifen and adrenal steroids have also been attributed to significant NAFLD. The key to management of NAFLD at this time are dietary changes and exercise to achieve weight loss. Unfortunately, a large proportion of the patients with these endocrine disorders are unable to achieve either. This review aims to examine and summarize the current published literature that have evaluated the association between NAFLD and the above endocrine disorders and potential therapeutic interventions in each case.

PMID: 29873585 [PubMed - indexed for MEDLINE]

Methodological problems in the method used by IQWiG within early benefit assessment of new pharmaceuticals in Germany.

Eur J Health Econ. 2019 Feb;20(1):45-57

Authors: Herpers M, Dintsios CM

Abstract
BACKGROUND: The decision matrix applied by the Institute for Quality and Efficiency in Health Care (IQWiG) for the quantification of added benefit within the early benefit assessment of new pharmaceuticals in Germany with its nine fields is quite complex and could be simplified. Furthermore, the method used by IQWiG is subject to manifold criticism: (1) it is implicitly weighting endpoints differently in its assessments favoring overall survival and, thereby, drug interventions in fatal diseases, (2) it is assuming that two pivotal trials are available when assessing the dossiers submitted by the pharmaceutical manufacturers, leading to far-reaching implications with respect to the quantification of added benefit, and, (3) it is basing the evaluation primarily on dichotomous endpoints and consequently leading to an information loss of usable evidence.
OBJECTIVE: To investigate if criticism is justified and to propose methodological adaptations.
METHODS: Analysis of the available dossiers up to the end of 2016 using statistical tests and multinomial logistic regression and simulations.
RESULTS: It was shown that due to power losses, the method does not ensure that results are statistically valid and outcomes of the early benefit assessment may be compromised, though evidence on favoring overall survival remains unclear. Modifications, however, of the IQWiG method are possible to address the identified problems.
CONCLUSION: By converging with the approach of approval authorities for confirmatory endpoints, the decision matrix could be simplified and the analysis method could be improved, to put the results on a more valid statistical basis.

PMID: 29696458 [PubMed - indexed for MEDLINE]

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 2019/06/18

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.

Low-dose ritonavir-boosted darunavir once daily versus ritonavir-boosted lopinavir for participants with less than 50 HIV RNA copies per mL (WRHI 052): a randomised, open-label, phase 3, non-inferiority trial.

Lancet HIV. 2019 Jun 12;:

Authors: Venter WDF, Moorhouse M, Sokhela S, Serenata C, Akpomiemie G, Qavi A, Mashabane N, Arulappan N, Sim JW, Sinxadi PZ, Wiesner L, Maharaj E, Wallis C, Boyles T, Ripin D, Stacey S, Chitauri G, Hill A

Abstract
BACKGROUND: Pilot studies suggest that ritonavir-boosted darunavir could show high efficacy at doses below those currently approved. We investigated whether switch to 400 mg of darunavir boosted with 100 mg ritonavir once daily could show equivalent efficacy to continuation of ritonavir-boosted lopinavir (a protease inhibitor commonly used in low-income and middle-income countries) for individuals with HIV RNA suppression.
METHODS: In the WRHI 052 study, a randomised, parallel-group, open-label, non-inferiority phase 3 trial, adults who were HIV-1 positive were enrolled in Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa. Eligible participants were 18 years or older, who tolerated ritonavir-boosted lopinavir in combination with two nucleoside analogues (standard of care) for 6 months or more, and had plasma HIV-1 RNA of less than 50 copies per mL within 60 days of enrolment. We randomly assigned participants (1:1), using a computer-generated randomisation plan, to switch to darunavir (400 mg) boosted with ritonavir (100 mg) once daily or remain on ritonavir-boosted lopinavir (800 mg [plus 200 mg ritonavir]), with nucleoside analogues left unchanged. The primary endpoint was the proportion of patients with less than 50 HIV-1 RNA copies per mL at week 48 (US Food and Drug Administration snapshot algorithm; non-inferiority margin -4%). Primary and safety analyses included participants receiving at least one dose of darunavir boosted with ritonavir. This trial is registered with ClinicalTrials.gov, number NCT02671383.
FINDINGS: Between June 30, 2016, and June 15, 2017, 148 participants were assigned to ritonavir-boosted darunavir 400 mg and 152 continued on their lopinavir-containing regimen. Four (3%) patients in the darunavir group and three (2%) in the lopinavir group discontinued before week 48. At week 48, darunavir was non-inferior to lopinavir for the primary outcome (142 [96%] of 148 participants on darunavir had <50 HIV-1 RNA copies per mL vs 143 [94%] of 152 participants on lopinavir; difference 1·9% [95% CI -3·4 to 7·3]), with a predefined margin of -4%. More participants taking darunavir (30 [20%] participants) had drug-related adverse events than those on lopinavir (eight [5%]), but the adverse events were generally asymptomatic and resolved when switching back to lopinavir. Elevated liver transaminase in three (1%; one symptomatic) darunavir participants led to study withdrawal; all transaminase elevations resolved on restarting lopinavir.
INTERPRETATION: Low-dose ritonavir-boosted darunavir might be a safe and efficacious switch option to maintain HIV suppression for patients on lopinavir. However, an adequately powered and designed study in viraemic participants is needed.
FUNDING: South African Medical Research Council, United States Agency for International Development, and US National Institute of Allergy and Infectious Diseases.

PMID: 31202690 [PubMed - as supplied by publisher]

Adalimumab in juvenile-idiopathic arthritis-associated uveitis (JIA-U): 5-year follow-up of the Bristol participants of the SYCAMORE trial.

Am J Ophthalmol. 2019 Jun 12;:

Authors: Horton S, Jones AP, Guly CM, Hardwick B, Beresford MW, Lee RWJ, Dick AD, Ramanan AV

Abstract
PURPOSE: To determine longer-term outcomes of participants enrolled from a single center in the SYCAMORE trial, a randomized placebo-controlled trial of adalimumab versus placebo in children with juvenile idiopathic arthritis-associated uveitis (JIA-U) uncontrolled on methotrexate.
DESIGN: Retrospective interventional case series.
METHODS: Medical records of all 28 SYCAMORE participants recruited at the Bristol Eye Hospital were reviewed at approximately 3-monthly intervals up to 5 years from the trial randomization date. Uveitis activity, treatment course, visual outcomes, ocular complications and adverse events were recorded. Data are presented using summary statistics.
RESULTS: Following withdrawal of the investigational medicinal product (IMP), 25 of the 28 participants were started on adalimumab for active juvenile idiopathic arthritis-associated uveitis (JIA-U). Of the 12 participants in the active treatment arm of the SYCAMORE study, 11 (92%) were restarted on adalimumab after withdrawal of the IMP for active JIA-U (median time to flare 188 days (range 42-413)). Two participants stopped adalimumab for uncontrolled JIA-U. One participant had a reduction in vision to 0.3 due to cataract. Mean visual acuity for the remaining 27 participants was -0.04 (right eye) and -0.05 (left eye).
CONCLUSIONS: Drug-induced remission of JIA-U did not persist when adalimumab was withdrawn after 1-2 years treatment. Adalimumab was well tolerated and visual acuity outcomes were excellent.

PMID: 31201796 [PubMed - as supplied by publisher]

Safety of parenteral ketorolac use for analgesia in geriatric emergency department patients.

Am J Emerg Med. 2019 Jun 06;:

Authors: Anderson GL, Mattson AE, Brown CS, Cabrera D, Mara KC, Bellolio MF

Abstract
OBJECTIVE: To assess the safety of a single dose of parenteral ketorolac for analgesia management in geriatric emergency department (ED) patients.
METHODS: This was a retrospective study of all administrations of parenteral ketorolac to adults ≥65 years of age and matched controls. The primary outcome was the occurrence of any of the following adverse events within 30 days of the ED visit: gastrointestinal bleeding, intracranial bleeding, acute decompensated heart failure, acute coronary syndrome, dialysis, transfusion, and death. The secondary outcome was the occurrence of an increase in serum creatinine of ≥1.5 times baseline within 7 and 30 days of the ED visit.
RESULTS: There were 480 patients included in the final analysis, of which 120 received ketorolac (3: 1 matching). The primary outcome occurred in 14 of 360 patients who did not receive ketorolac and 2 of 120 ketorolac patients (3.9% vs 1.7%, p = 0.38; OR 2.39, 95% CI 0.54-10.66). There was no occurrence of dialysis or death in either group. The secondary outcome occurred in 1 of 13 and 1 of 23 ketorolac patients with both a baseline serum creatinine and a measure within 7 and 30 days, respectively, but did not occur in patients who did not receive ketorolac (7 days: 7.7% vs 0.0%, p = 0.29; 30 days: 4.4% vs 0.0%, p = 0.22).
CONCLUSION: The use of single doses of parenteral ketorolac for analgesia management was not associated with an increased incidence of adverse cardiovascular, gastrointestinal, or renal adverse outcomes in a select group of older adults.

PMID: 31201117 [PubMed - as supplied by publisher]

Nonsteroidal FXR Ligands: Current Status and Clinical Applications.

Handb Exp Pharmacol. 2019 Jun 14;:

Authors: Gege C, Hambruch E, Hambruch N, Kinzel O, Kremoser C

Abstract
FXR agonists have demonstrated very promising clinical results in the treatment of liver disorders such as primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH). NASH, in particular, is one of the last uncharted white territories in the pharma landscape, and there is a huge medical need and a large potential pharmaceutical market for a NASH pharmacotherapy. Clinical efficacy superior to most other treatment options was shown by FXR agonists such as obeticholic acid (OCA) as they improved various metabolic features including liver steatosis as well as liver inflammation and fibrosis. But OCA's clinical success comes with some major liabilities such as pruritus, high-density lipoprotein cholesterol (HDLc) lowering, low-density lipoprotein cholesterol (LDLc) increase, and a potential for drug-induced liver toxicity. Some of these effects can be attributed to on-target effects exerted by FXR, but with others it is not clear whether it is FXR- or OCA-related. Therefore a quest for novel, proprietary FXR agonists is ongoing with the aim to increase FXR potency and selectivity over other proteins and to overcome at least some of the OCA-associated clinical side effects through an improved pharmacology. In this chapter we will discuss the historical and ongoing efforts in the identification and development of nonsteroidal, which largely means non-bile acid-type, FXR agonists for clinical use.

PMID: 31197565 [PubMed - as supplied by publisher]

[Is serious dermal reaction to drugs avoidable?]

Ann Dermatol Venereol. 2018 Nov;145(11):728-729

Authors: Schmutz JL

PMID: 30340771 [PubMed - indexed for MEDLINE]