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https://www.readbyqxmd.com/read/28812471/effectiveness-and-tolerability-of-parenteral-testosterone-undecanoate-a-post-marketing-surveillance-study
#1
Jan Wolf, Dieter Keipert, Heiko Motazedi, Michael Ernst, Joanne Nettleship, Louis Gooren
This observational post-marketing study of parenteral testosterone undecanoate (TU) in a non-selected population aimed to: examine the effectiveness of TU as treatment of hypogonadism; record adverse drug reactions (ADR) quantitatively particularly regarding polycythemia, prostate safety and cardiovascular-related metabolic risk factors; and verify whether recommended injection intervals apply to routine clinical practice. Eight hundred and seventy subjects from 259 outpatient units scheduled to visit the clinic six times were included...
August 16, 2017: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
https://www.readbyqxmd.com/read/28811808/prevention-of-anesthesia-induced-injection-pain-of-propofol-in-pediatric-anesthesia
#2
Dabin Cheng, Lu Liu, Zheng Hu
OBJECTIVE: Propofol is a new anesthetic agent in clinical practice, but randomized double-blinded prospective studies on its role in pediatric anesthesia remain limited. We aimed to compare the preventive effects of pre-injected lidocaine or ketamine and its pre-mixture on the anesthesia-induced injection pain of propofol using a randomized double-blinded prospective method, and to compare the outcomes with those of medium-/long-chain propofol (M/LCT). METHODS: A total of 360 pediatric patients (aged 5-12 years old) who received elective surgery were randomly divided into six groups (n= 60) as follows...
May 2017: Pakistan Journal of Medical Sciences Quarterly
https://www.readbyqxmd.com/read/28810313/-efficacy-and-safety-of-tiotropium-respimat-in-the-treatment-of-chronic-obstructive-pulmonary-disease-systematic-review
#3
H D Cai, J Hou, Y N Lyu, L Xiong, M Z Lu, S L Wu
Objective: To evaluate the efficacy and safety of tiotropium Respimat in the treatment of chronic obstructive pulmonary disease (COPD) according to the Cochrane systematic evaluation. Methods: The Cochrane Library, PubMed, EMbase, CNKI, VIP and CBM, Wanfang Data were searched(from the foundation date to Jan. 2016) for the randomized controlled trials (RCTs) of tiotropium Respimat in the treatment of patients with COPD. Two reviewers independently retrieved the RCTs according to the inclusion and exclusion criteria, assessed the methodological quality of the included trials...
August 12, 2017: Chinese Journal of Tuberculosis and Respiratory Diseases
https://www.readbyqxmd.com/read/28809990/topical-desoximetasone-0-25-spray-and-its-vehicle-have-little-potential-for-irritation-or-sensitization
#4
Anish Nadkarni, Mohammed D Saleem, Steven R Feldman
<p>BACKGROUND: Topical corticosteroids are the most common dermatologic medications and are available in numerous different vehicles. Adherence is limited by traditional vehicles because they are messy and time consuming to apply. The preferred spray formulations have the advantage of being applied with ease, resulting in improved adherence and subsequently improved psoriasis. One limitation of topical treatments, especially spray vehicles, is the potential for irritation and sensitization.</p> <p>OBJECTIVE: To evaluate the irritation and sensitization potential of topical desoximetasone spray formulation...
August 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28809071/physicians-communication-of-risks-from-non-steroidal-anti-inflammatory-drugs-and-attitude-towards-providing-adverse-drug-reaction-information-to-patients
#5
Pacharaporn Phueanpinit, Juraporn Pongwecharak, Sermsak Sumanont, Janet Krska, Narumol Jarernsiripornkul
RATIONALE, AIMS, AND OBJECTIVES: Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for orthopaedic conditions, therefore this study aimed to explore orthopaedic physicians' perceptions of their role in NSAID-risk communication, their attitudes towards the necessity of informing patients about adverse drug reactions (ADR), and factors associated with these. METHODS: Self-administered questionnaires were mailed to all 206 orthopaedic physicians working at hospitals in Northeastern Thailand...
August 15, 2017: Journal of Evaluation in Clinical Practice
https://www.readbyqxmd.com/read/28808959/deaths-from-medicines-a-systematic-analysis-of-coroners-reports-to-prevent-future-deaths
#6
Robin E Ferner, Craig Easton, Anthony R Cox
INTRODUCTION: Since legislation in 2009, coroners in England and Wales must make reports in cases where they believe it is possible to prevent future deaths. We categorised the reports and examined whether they could reveal preventable medication errors or novel adverse drug reactions. METHODS: We examined 500 coroners' reports by pre-defined criteria to identify those in which medicines played a part, and to collect information on coroners' concerns. RESULTS: We identified 99 reports (100 deaths) in which medicines or a part of the medication process or both were mentioned...
August 14, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28806959/second-line-therapy-for-helicobacter-pylori-eradication-causing-antibiotic-associated-hemorrhagic-colitis
#7
Kazuyuki Tanaka, Mikihiro Fujiya, Aki Sakatani, Shugo Fujibayashi, Yoshiki Nomura, Nobuhiro Ueno, Shin Kashima, Takuma Goto, Junpei Sasajima, Kentaro Moriichi, Toshikatsu Okumura
OBJECTIVE: Helicobacter pylori (H. pylori) eradication rarely develops into antibiotic-associated hemorrhagic colitis (AAHC), in which the etiology of colitis remains unclear. We herein report a rare case of AAHC caused by second-line therapy for H. pylori eradication. RESULTS: A 65-year-old female was administered second-line therapy for H. pylori composed of 1500 mg of amoxicillin, 500 mg of metronidazole and 40 mg of vonoprazan for 7 days because of first-line therapy failure...
August 14, 2017: Annals of Clinical Microbiology and Antimicrobials
https://www.readbyqxmd.com/read/28805982/a-serious-nightmare-psychiatric-and-neurologic-adverse-reactions-to-mefloquine-are-serious-adverse-reactions
#8
Remington L Nevin
Mefloquine (originally marketed as Lariam) is a neurotoxic quinoline derivative antimalarial drug that is known to cause serious and potentially lasting neuropsychiatric adverse reactions. Since 2013, drug regulators in several jurisdictions, including the United States, the United Kingdom, Ireland, and Canada, have required their mefloquine labels be updated to warn that when used for malaria prophylaxis the drug should be discontinued at the onset of neurologic or psychiatric symptoms. These recent changes to the international labeling serve to imply that psychiatric and neurologic reactions to mefloquine prophylaxis may be an early warning of an impending more serious reaction that may further jeopardize the patient with continued use of the drug...
August 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28803520/probable-rivaroxaban-induced-full-body-rash-a-case-report
#9
Evan Sasson, Marian James, Mark Russell, Darko Todorov, Henry Cohen
INTRODUCTION: Rivaroxaban is a novel oral anticoagulant with several indications, one of which is for stroke prevention in nonvalvular atrial fibrillation. We present a case of probable rivaroxaban-induced rash. CASE SUMMARY: A 79-year-old female with a medical history of atrial fibrillation experienced a stroke, after which she was prescribed rivaroxaban 20 mg. After several days, she developed a rash requiring admission to the emergency department and several days of treatment...
January 1, 2017: Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/28803185/risk-of-allergic-reactions-to-recurrent-intravenous-penicillin-administration-in-penicillin-skin-test-negative-patients
#10
Steve M Dorman, Sharon Seth, David A Khan
BACKGROUND: Patients with a history of penicillin allergy who are found to be skin test negative to penicillin are able to tolerate repeated oral doses of penicillin with low rates of resensitization. However, the resensitization rate after repeated doses of intravenous penicillin is less clear. OBJECTIVE: We sought to evaluate the risk of allergic reactions to repeated doses of intravenous penicillin in patients who previously reported penicillin allergy and were found to be penicillin skin test and oral challenge negative...
August 9, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28801750/cutaneous-drug-reactions-in-the-elderly
#11
REVIEW
James W S Young, Neil H Shear
Cutaneous adverse drug reactions comprise a significant proportion of all adverse drug reactions. They may mimic other dermatologic or systemic illnesses and may cause significant morbidity or mortality. Seven morphologic groups encompass the most commonly encountered cutaneous drug reaction syndromes: exanthematous (maculopapular), dermatitic/eczematous, urticarial, pustular, blistering, purpuric, and erythrodermic. Drug reactions may have significant downstream consequences for the older individual.
August 11, 2017: Drugs & Aging
https://www.readbyqxmd.com/read/28799976/effect-of-gene-gene-and-gene-environment-interactions-associated-with-antituberculosis-drug-induced-hepatotoxicity
#12
Julián G Chamorro, Jorge P Castagnino, Omar Aidar, Rosa M Musella, Ana Frías, Mabel Visca, Mabel Nogueras, Lucas Costa, Alessandro Perez, Fabio Caradonna, Gabriela F de Larrañaga
OBJECTIVES: This study evaluated the association between environmental factors and genetic variations in enzymes that metabolize antituberculosis (anti-TB) drugs [arylamine N-acetyltransferase 2, cytochrome P450 2E1 (CYP2E1), glutathione S-transferase theta 1 (GSTT1), and glutathione S-transferase mu 1] with antituberculosis drug-induced hepatotoxicity (ATDH). We also investigated the potential gene-gene and gene-environment interactions as well as their association with ATDH development in a population of hospitalized TB patients from Buenos Aires...
August 9, 2017: Pharmacogenetics and Genomics
https://www.readbyqxmd.com/read/28799514/potentially-clinically-relevant-pharmacodynamic-interactions-between-antiepileptic-drugs-and-psychotropic-drugs-an-update
#13
Edoardo Spina, Jose de Leon
BACKGROUND: Prior articles paid little attention to pharmacodynamic drug interactions (DIs) between antiepileptic drugs (AEDs) and the most important psychotropic medications (antidepressants, antipsychotics, benzodiazepines and lithium) which have potential to be clinically relevant. OBJECTIVE: This article aims to provide an updated review of the potentially clinically relevant pharmacodynamic DIs between AEDs and psychotropic medications. Pharmacodynamic DIs take place directly at the site of action of a drug or indirectly by interfering with another physiological mechanism...
August 9, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28799510/safety-profile-of-the-newest-antiepileptic-drugs-a-curated-literature-review
#14
Caterina Palleria, Giuseppe Cozza, Rajeshree Khengar, Vincenzo Libri, Giovambattista De Sarro
BACKGROUND: Despite the introduction of new antiepileptic drugs (AEDs), the quality of life and therapeutic response for patients with epilepsy remain unsatisfactory. In addition, whilst several antiepileptic drugs (AEDs) have been approved and consequently marketed in recent years, little is known about their long-term safety and tolerability. Availability of the newest AEDs, characterized by improved pharmacokinetic profiles, has positively impacted the treatment approach for patients with partial seizures in clinical practice...
August 9, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28797192/profiling-extractable-and-leachable-inorganic-impurities-in-ophthalmic-drug-containers-by-icp-ms
#15
Paige Solomon, Jenny Nelson
In this study, we investigated the elemental impurities present in the plastic material of ophthalmic eye drop bottles using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). Metallic contaminations, especially localized within the small cavity of the eye, can significantly perturb the ocular metallome. The concern is two-fold: first certain elements, for example heavy metals, can be toxic to humans at even trace levels, and second, these contaminations can have adverse reactions with other medicines or enzymatic processes in the eye...
August 11, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28796198/in-vitro-assays-in-severe-cutaneous-adverse-drug-reactions-are-they-still-research-tools-or-diagnostic-tests-already
#16
Grzegorz Porebski
Severe cutaneous adverse drug reactions (SCARs) represent life-threatening medical conditions and an appropriate causative diagnosis of these conditions is of the highest importance. Existing in vivo diagnostic methods are risky or are just contraindicated in these patients. Therefore, in vitro tests take on greater significance. In this survey, the studies on in vitro assays in SCARs were identified with a defined searching strategy and strict eligibility criteria. Different methods in the particular clinical manifestations and the groups of drugs were compared in respect to the diagnostic parameters obtained...
August 10, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28794551/efficacy-and-safety-of-terbinafine-500-mg-once-daily-in-patients-with-dermatophytosis
#17
P Ravindra Babu, A J S Pravin, Gaurav Deshmukh, Dhiraj Dhoot, Aniket Samant, Bhavesh Kotak
INTRODUCTION: Dermatophytosis are the most common fungal infections globally. Terbinafine is considered to have good potency against dermatophytes, but resistance to terbinafine is on the rise. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of terbinafine 500 mg given once daily in treatment of patients with superficial dermatophytosis. MATERIALS AND METHODS: It was a retrospective questionnaire-based survey...
July 2017: Indian Journal of Dermatology
https://www.readbyqxmd.com/read/28794549/ethics-of-safety-reporting-of-a-clinical-trial
#18
Amrita Sil, Nilay Kanti Das
Clinical trial related injury and serious adverse events (SAE) are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases...
July 2017: Indian Journal of Dermatology
https://www.readbyqxmd.com/read/28794532/local-anaesthetic-systemic-toxicity-following-oral-ingestion-in-a-child-revisiting-dibucaine
#19
Raylene Dias, Nandini Dave, Milind S Tullu, Chandrahas T Deshmukh
Dibucaine, a potent and toxic local anaesthetic, although currently withdrawn by the United States Food and Drug Administration for use as a spinal anaesthetic, continues to remain available in many over-the-counter topical formulations. Systemic toxicity following oral ingestion of local anaesthetics is rare. We report a case of accidental ingestion of dibucaine (ear drops) in a 7-year-old child who developed diplopia, giddiness, ventricular premature contractions and a right bundle branch block. We also present a brief discussion on the pharmacologic and toxicity profile of dibucaine, the Naranjo algorithm for assessing causality in case of adverse drug reactions and a review of current guidelines on the management of local anaesthetic systemic toxicity...
July 2017: Indian Journal of Anaesthesia
https://www.readbyqxmd.com/read/28794523/safety-monitoring-of-local-anaesthetic-drugs-from-the-perspective-of-pharmacovigilance-programme-of-india
#20
Pramod Kumar, Ismeet Kaur, Vivekanandan Kalaiselvan, Abhishank Singh
Pharmacovigilance Programme of India (PvPI) was established to promote patient safety by the Ministry of Health and Family Welfare, Government of India in July 2010. It covers various medical hospitals/institutes and National Health Programmes across the country. India is coordinating with various national and international programmes to be a part of international drug monitoring and to monitor the risk-benefit profile of medicines. At present, India has contributed more than 200,000 adverse drug reactions (ADRs) to the database and can draw signals for regulatory decisions...
July 2017: Indian Journal of Anaesthesia
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