scholarly journals Adverse drug reactions in primary care: a scoping review

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
H. Khalil ◽  
C. Huang
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Patient Safety ◽  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Scoping Review ◽  
Primary Healthcare ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
The Central Nervous System

Abstract Background Medication-related adverse events, or adverse drug reactions (ADRs) are harmful events caused by medication. ADRs could have profound effects on the patients’ quality of life, as well as creating an increased burden on the healthcare system. ADRs are one of the rising causes of morbidity and mortality internationally, and will continue to be a significant public health issue with the increased complexity in medication, to treat various diseases in an aging society. This scoping review aims to provide a detailed map of the most common adverse drug reactions experienced in primary healthcare setting, the drug classes that are most commonly associated with different levels/types of adverse drug reactions, causes of ADRs, their prevalence and consequences of experiencing ADRs. Methods We systematically reviewed electronic databases Ovid MEDLINE, Embase, CINAHL Plus, Cochrane Central Register of Controlled Trials, PsycINFO and Scopus. In addition, the National Patient Safety Foundation Bibliography and the Agency for Health Care Research and Quality and Patient Safety Net Bibliography were searched. Studies published from 1990 onwards until December 7, 2018 were included as the incidence of reporting drug reactions were not prevalent before 1990. We only include studies published in English. Results The final search yielded a total of 19 citations for inclusion published over a 15-year period that primarily focused on investigating the different types of adverse drug reactions in primary healthcare. The most causes of adverse events were related to drug related and allergies. Idiosyncratic adverse reactions were not very commonly reported. The most common adverse drug reactions reported in the studies included in this review were those that are associated with the central nervous system, gastrointestinal system and cardiovascular system. Several classes of medications were reported to be associated with adverse events. Conclusion This scoping review identified that the most causes of ADRs were drug related and due to allergies. Idiosyncratic adverse reactions were not very commonly reported in the literature. This is mainly because it is hard to predict and these reactions are not associated with drug doses or routes of administration. The most common ADRs reported in the studies included in this review were those that are associated with the central nervous system, gastrointestinal system and cardiovascular system. Several classes of medications were reported to be associated with ADRs.

scholarly journals CYP2D6 in the Brain: Potential Impact on Adverse Drug Reactions in the Central Nervous System—Results From the ADRED Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Katja S. Just ◽  
Harald Dormann ◽  
Mathias Freitag ◽  
Marlen Schurig ◽  
Miriam Böhme ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Drug Metabolism ◽  
Adverse Drug Reactions ◽  
Drug Exposure ◽  
Drug Reactions ◽  
Cyp2d6 Activity ◽  
Secondary Analyses ◽  
The Central Nervous System ◽  
The Brain

Cytochrome P450 (CYP) 2D6 is a polymorphic enzyme expressed in the central nervous system (CNS), important in drug metabolism and with a potentially constitutive role in CNS function such as vigilance. This study aimed to analyze variability in CYP2D6 activity linked to vigilance-related adverse drug reactions (ADRs) in the CNS. A dataset of N = 2939 ADR cases of the prospective multicenter observational trial in emergency departments (EDs) (ADRED; trial registration: DRKS-ID: DRKS00008979) was analyzed. Dizziness as the most frequent reported CNS ADR symptom (12.7% of patients, n = 372) related to vigilance was chosen as the outcome. The association of dizziness with CYP2D6 activity markers was analyzed. The number of CYP2D6 substrates taken, a CYP2D6 saturation score (no, moderate, and strong saturation), a CYP2D6 saturation/inhibition score (no, weak, moderate, and strong), and composed CYP2D6 activity using a genotyped subsample (n = 740) calculating additive effects of genotype and CYP2D6 saturation by drug exposure were used as CYP2D6 activity markers. Effects were compared to other frequent nonvigilance-related CNS ADR symptoms (syncope and headache). Secondary analyses were conducted to control for other ADR symptoms frequently associated with dizziness (syncope, nausea, and falls). The majority of all patients (64.5%, n = 1895) took at least one drug metabolized by CYP2D6. Around a third took a CNS drug (32.5%, n = 955). The chance to present with drug-related dizziness to the ED increased with each CYP2D6 substrate taken by OR 1.11 [1.01–1.23]. Presenting with drug-related dizziness was more likely with CYP2D6 saturation and saturation/inhibition (both OR 1.27 [1.00–1.60]). The composed CYP2D6 activity was positively associated with dizziness (p = 0.028), while poorer activity affected patients more often with dizziness as an ADR. In contrast, nonvigilance-related ADR symptoms such as syncope and nausea were not consistently significantly associated with CYP2D6 activity markers. This study shows an association between the number of CYP2D6 substrates, the predicted CYP2D6 activity, and the occurrence of dizziness as a CNS ADR symptom. As dizziness is a vigilance-related CNS symptom, patients with low CYP2D6 activity might be more vulnerable to drug-related dizziness. This study underlines the need for understanding individual drug metabolism activity and individual risks for ADRs.

scholarly journals Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

2021 ◽  
Vol 9 (1) ◽  
pp. 34-42
Author(s):  
E. Yu. Demchenkova ◽  
G. I. Gorodetskaya ◽  
I. A. Mazerkina ◽  
M. V. Zhuravleva ◽  
A. S. Kazakov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Patient Information ◽  
Adverse Reactions ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
Spontaneous Reports ◽  
Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

scholarly journals Memantine as an Augmentation Therapy for Anxiety Disorders

2012 ◽  
Vol 2012 ◽  
pp. 1-3 ◽  
Author(s):  
Thomas L. Schwartz ◽  
Umar A. Siddiqui ◽  
Shafi Raza
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Nmda Receptor ◽  
Adverse Events ◽  
Nmda Receptor Antagonist ◽  
Augmentation Therapy ◽  
Treatment Resistant ◽  
Excitatory Neurotransmitter ◽  
The Central Nervous System ◽  
Development Of Anxiety

Objective. Glutamate, an excitatory neurotransmitter in the central nervous system (CNS), may play a role in the development of anxiety. Memantine partially blocks N-methyl-D-aspartate (NMDA) receptors' glutamate channels located in the CNS. This paper evaluates memantine as an augmentation therapy for treatment of anxiety.Methods. 15 consecutive partially responding anxious patients were treated with adjunctive memantine for 10 weeks. Memantine was dosed 5–20 mg/day.Result. Memantine augmentation resulted in clinically relevant reduction in anxiety symptoms when compared to baseline. Forty percent of patients achieved remission (HAM-A ≥ 7). Memantine improved sleep quality. Mean dose was 14 mg/d (range 5–20 mg/d). Typical adverse events included nausea and headache.Conclusion. The NMDA receptor antagonist memantine may be an effective augmentation therapy in patients with treatment-resistant anxiety.

scholarly journals Ixekizumab for patients with plaque psoriasis affected by multiple sclerosis

2021 ◽  
Author(s):  
Enrique Herrera-Acosta ◽  
Gustavo Guillermo Garriga Martina ◽  
Jorge Alonso Suárez-Pérez ◽  
Eliseo Alejandro Martínez-García ◽  
Enrique Herrera-Ceballos
Keyword(s):  
Multiple Sclerosis ◽  
Central Nervous System ◽  
Monoclonal Antibody ◽  
Nervous System ◽  
Adverse Events ◽  
Plaque Psoriasis ◽  
Neurological Disease ◽  
Chronic Plaque Psoriasis ◽  
Demyelinating Disorder ◽  
The Central Nervous System

Multiple sclerosis is an autoimmune demyelinating disorder of the central nervous system that shares similar immunopathogenic mechanisms with chronic plaque psoriasis, such as the overexpression of the Th17 pathway. We report the case of a patient with multiple sclerosis and severe chronic plaque psoriasis successfully treated with ixekizumab (anti IL-17A and IL-17A/F monoclonal antibody). The treatment achieved a complete skin clearance (PASI 100 response) with no adverse events or evidence of progression of the neurological disease. Keywords: Psoriasis; Ixekizumab; Multiple sclerosis

Pharmacogenomics and pharmacokinetics of efavirenz 400 or 600 mg in 184 treatment-naive HIV-infected patients in China

2020 ◽  
Vol 21 (13) ◽  
pp. 945-956
Author(s):  
Rong Chen ◽  
Jun Chen ◽  
Jingna Xun ◽  
Zhiliang Hu ◽  
Qiong Huang ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Body Weight ◽  
Plasma Levels ◽  
Dose Group ◽  
Adverse Reactions ◽  
Standard Dose ◽  
Treatment Naïve ◽  
The Central Nervous System ◽  
To Receive

Background: The pharmacogenomics and pharmacokinetics/pharmacodynamics of 400 mg efavirenz have rarely been reported. Materials & methods: A total of 184 treatment-naive HIV-infected patients were randomly assigned (1:1) to receive a lower dose (tenofovir disoproxil 200 mg, efavirenz 400 mg and lamivudine) or a standard dose regimen. Relationships between pharmacogenomics and efavirenz pharmacokinetics/pharmacodynamics were explored at 48 weeks. Results: There was no relationship between pharmacogenomics and adverse reactions of the central nervous system and antiretoviral efficacy. CYP2B6 516G>T, 785A>G, 18492C>T and ABCB1 3435C>T T/C were associated with higher efavirenz plasma levels in the standard but not the lower dose group. No relationship was found between pharmacogenomics and antiretoviral efficacy. Patients who were <60 kg had higher efavirenz concentration compared with those with weight ≥60 kg when using 600 mg efavirenz, this was not observed with 400 mg efavirenz. Conclusion: The effect of pharmacogenomics and body weight on the efavirenz concentration was significant in the 600 mg group but not in the 400 mg group.

Evaluation of safety and side effects in the process of anti-anxiety drug development *

1993 ◽  
Vol 8 (6) ◽  
pp. 285-291 ◽  
Author(s):  
M Bourin ◽  
A Couetoux du Tertre ◽  
R Payeur
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Side Effects ◽  
Adverse Events ◽  
Vital Signs ◽  
The Elderly ◽  
System Level ◽  
The Central Nervous System ◽  
Drug Type ◽  
Central Nervous System Level

SummaryAs with other drugs it is necessary to look for changes induced by anxiolytics on vital signs, laboratory parameters and adverse events. In return, in a more specific way for anxiolytics, we will look at side effects at the central nervous system level with psychological and physiological battery tests. We will also assess the safety of use of anxiolytics in certain specific conditions, such as overdose or withdrawal and in certain populations such as the elderly, neonates and children. The assessment of safety and side effects, whatever the drug type studied, must come early in the developing process of a drug (phases I, II and III).

scholarly journals Informal Trade of Psychoactive Herbal Products in the City of Diadema, SP, Brazil: Quality and Potential Risks

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Julino Assunção Rodrigues Soares Neto ◽  
Edna Myiake Kato ◽  
Adriana Bugno ◽  
José Carlos F. Galduróz ◽  
Luis Carlos Marques ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Drug Interactions ◽  
Adverse Reactions ◽  
Microbiological Analysis ◽  
Herbal Products ◽  
Informal Trade ◽  
The Central Nervous System ◽  
Potential Risks ◽  
The City

The present study aimed to assess the quality and risks involved in the consumption of psychoactive herbal products (PHs) that are available through informal commerce in the city of Diadema, SP, Brazil. Methods of ethnography were used to conduct the fieldwork during which four dealers were selected to record the collection, handling, packaging, types of PHs marketed, and their therapeutic purposes. In addition, lots of the PHs selected were purchased from the dealers and analyzed using microbiology and pharmacognosy techniques. 217 PHs were recorded and categorized into two main groups:stimulants(67%) anddepressants(27%) of the central nervous system; sixteen of them were selected, and their 52 lots were acquired. The deficiencies observed in handling and packaging these lots by dealers were confirmed by microbiological analysis; 80.8% of them presented risk according to the indicators defined by the Brazilian Pharmacopoeia. The pharmacognostic analysis confirmed the authenticity of only 9 to 16 PHs analyzed. In addition, descriptions of contraindications, adverse reactions, and drug interactions were found in the literature for the PHs. The results of this study allow the observation of the priorities for the sanitary adequacy of the popular trade of herbs.

scholarly journals EFFICACY OF REFLEXOTHERAPY IN COMPLEX REHABILITATION IN CHILDREN WITH CEREBRAL PALSY BY ASSESSING (of life quality)

2018 ◽  
pp. 125-128
Author(s):  
І. I. Liskevich
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Cerebral Palsy ◽  
Comparative Effectiveness ◽  
Adverse Reactions ◽  
Life Quality ◽  
Clinical Effects ◽  
Social Rehabilitation ◽  
Children With Cerebral Palsy ◽  
The Central Nervous System

The article analyzes the reflexology techniques that are used in the system of rehabilitation  in children with cerebral palsy and comparative effectiveness  in 72 children who were on treatment at the center of early medical and social rehabilitation for children with organic damage of the central nervous system. The main clinical effects are shown and the frequency of adverse reactions of reflexotherapy in this category of patients is analyzed.

scholarly journals The pharmacovigilance of psychoactive medications in Brazil

2003 ◽  
Vol 25 (4) ◽  
pp. 200-205 ◽  
Author(s):  
Elisaldo Luiz de Araújo Carlini ◽  
Solange Aparecida Nappo
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Adverse Reaction ◽  
Adverse Reactions ◽  
Medication Withdrawal ◽  
Prolonged Hospitalization ◽  
Suspected Adverse Reactions ◽  
Life Threatening ◽  
The Central Nervous System ◽  
Psychoactive Medications

OBJETIVE: The present study aimed to analyze 219 notifications of suspected adverse reactions (AR) produced by psychoactive medicaments (ARPM), notified by Brazilian psychiatrists, during a 3-month period (April 1999 up to September 2001). METHOD: A notifying card for adverse reactions possibly produced by psychoactive medications was quarterly sent to all psychiatrists affiliated to the Brazilian Association of Psychiatry. Once each notification, dully filled in, was received, the possible adverse reaction was analyzed in order to verify the causality RESULTS: The psychiatrists classified as severe 50 of the ARPMs; 150 others were not considered as severe. Among the severe ones there were 3 deaths, 12 life-threatening reactions, 26 ARPMs required or prolonged hospitalization and 9 notifications described temporary disability of the patients. Among the medications, antidepressants ranked first with 122 ARPMs being notified, followed by neuroleptics (46 ARPMs) and antiepiletic medicaments (25 ARPMs). The three main organs and systems affected by the ARs were the Central Nervous System with 102 ARs, skin and mucosa with 44 and gastrointestinal with 21 ARPMs. CONCLUSION: Considering causality, i.e., the association between the medication and the described AR, 24 cases were considered as Definite (with positive dechallenge and rechallenge, i.e., withdrawal and reintroduction of the medication) and 134 other ARPMs were classified as Probable (only dechallenge positive; only with medication withdrawal; rechallenge was not performed).

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