Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices

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.

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Common Causes and Characteristics of Adverse Drug Reactions in Older Adults: A Retrospective Study

10.21203/rs.3.rs-58795/v3 ◽

2020 ◽

Author(s):

Seong-Dae Woo ◽

Jiwon Yoon ◽

Go-Eun Doo ◽

Youjin Park ◽

Youngsoo Lee ◽

...

Keyword(s):

Older Adults ◽

Adverse Drug Reactions ◽

Drug Reactions ◽

Younger Patients ◽

Iodinated Contrast ◽

Common Causes ◽

Aging Populations ◽

Pharmacovigilance Center ◽

Inflammatory Drugs ◽

Rate Ratios

Abstract Background: Aging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs). We sought to evaluate the causes and characteristics of ADRs in older Korean adults (≥65 years) in comparison to younger individuals (<65 years). Methods: Of 37,523 cases reported at a Korean pharmacovigilance center from 2011 to 2018, we reviewed 18,842 ADRs of certain or probable causality on the basis of WHO-UMC criteria. We estimated the number of ADRs per 1,000 patients exposed to the major culprit drugs, and incidence rate ratios were obtained to assess high- and low-risk medications in older adults. Results: In total, 4,152 (22.0%) ADRs were reported for 3,437 older adults (mean age, 74.6 years and 57.3% female). Tramadol (rate ratio, 1.32; 95% confidence interval [CI], 1.21-1.44; P <0.001) and fentanyl (1.49, 1.16-1.92, P =0.002) posed higher risks of ADRs in the older adults, whereas nonsteroidal anti-inflammatory drugs (NSAIDs) (0.35, 0.30-0.40, P <0.001) and iodinated contrast media (ICM) (0.82, 0.76-0.89, P <0.001) posed lower risks. Ratios of serious ADRs to NSAIDs (odds ratio, 2.16; 95% CI, 1.48-3.15; P <0.001) and ICM (2.09, 1.36-3.21, P= 0.001) were higher in the older adults than in the younger patients. Analgesics primarily elicited cutaneous ADRs in the younger patients and gastrointestinal reactions in the older adults. ICM more commonly led to anaphylaxis in the older adults than the younger patients (3.0% vs. 1.6%, P =0.019). Conclusion: For early detection of ADRs in older adults, better understanding of differences in the causes and characteristics thereof in comparison to the general population is needed.

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Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study

Pain Management Nursing ◽

10.1016/j.pmn.2018.01.008 ◽

2018 ◽

Vol 19 (4) ◽

pp. 333-339 ◽

Cited By ~ 2

Author(s):

Deborah Dillon McDonald ◽

Sarah Coughlin ◽

Candy Jin

Keyword(s):

Older Adults ◽

Pilot Study ◽

Adverse Drug Reactions ◽

Drug Reactions

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Study of adverse drug reactions and clinical profile of elderly in relation to polypharmacy

Asian Journal of Medical Sciences ◽

10.3126/ajms.v10i6.22757 ◽

2019 ◽

Vol 10 (6) ◽

pp. 80-84

Author(s):

Nagaraja BS ◽

Keerthana Sharma

Keyword(s):

Older Adults ◽

Adverse Drug Reactions ◽

The Elderly ◽

Control Group ◽

Case Group ◽

Drug Reactions ◽

Age Related ◽

Improve Compliance ◽

Clinical Conditions

Background: Polypharmacy is a becoming more prevalent in older adults and adverse risk increases with age-related change. Adverse drug reactions (ADRs) are common in older adults and worrisome aspect of treatment in elderly. Aims and Objective: The study aimed to identify the common clinical conditions leading to polypharmacy and to compare the adverse drug profiles of the 2 groups. Materials and Methods: This case-control study was conducted in Hospitals attached to BMCRI, where 200 patients aged 65 or more were interviewed. 100 elderly patients using 5 or more drugs were identified as cases and assessed against a control group of 100 patients. Results: Our study found that ADRs were found to be three times higher in individuals on polypharmacy compared to the control group (OR 3.4675 95% CI 1.6241 to 7.4035). The most commonly occurring ADRs were dyspepsia (OR 1.9259), drowsiness (OR 3.5926) and fatigue (OR 1.5319) with increased incidence in the case group. The most common conditions associated with polypharmacy were found to be hypertension (53%), diabetes mellitus(46%), COPD(14%) and IHD(14%). 66% of the study group had two or more of the above diseases, whereas in the control group only 32% had multiple illnesses. The most commonly prescribed medications were antihypertensives (61%), hypolipidemics (44%), antiplatelets (41%) and antibiotics(40%). Conclusion: Polypharmacy in the elderly comes with a significant increase in adverse effects. The reduced pill burden will not only decrease ADRs and improve compliance, but will also result in greater patient satisfaction and mental health, thereby improving the quality of geriatric care.

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