Adverse drug reactions and off-label prescribing for paediatric outpatients: a one-year survey of spontaneous reports in Sweden

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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An assessment of pattern of adverse drug reactions of cardiovascular drugs in a tertiary care institute

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20180097 ◽

2018 ◽

Vol 7 (2) ◽

pp. 273 ◽

Cited By ~ 1

Author(s):

Smita Y. Wankhede ◽

Milind L. Pardeshi ◽

Vishal V. Ghorpade ◽

Balasaheb B. Ghongane

Keyword(s):

Adverse Drug Reactions ◽

Demographic Data ◽

Tertiary Care ◽

Cardiovascular Drugs ◽

Care Hospital ◽

Drug Reactions ◽

Microsoft Excel ◽

Entire Study ◽

Cardiovascular Medications ◽

One Year

Background: Cardiovascular disease is very prevalent in India. So, use of cardiovascular drugs is also more. So, it is very important to keep watch on adverse drug reactions. Aim of this study was to assess the pattern of adverse drug reactions (ADRs) reported with cardiovascular drugs in a tertiary care institute.Methods: The study was carried out in medicine department of a tertiary care hospital over a period of one year. Each ADR was analysed for demographic data, causality, relationship between frequency of ADRs and the number of drugs used etc. In statistical analysis Microsoft excel 2013, SPSS software was used.Results: A total of 136 patients, 58 (43%) men and 78 (57%) women, using cardiovascular medications reported ADRs during the entire study period. Total 168 ADRs were reported out of which, Amlodipine (causing headache and edema feet) was the most common drug with 51 (30.3%) ADR’s followed by Enalapril, Aspirin and Isosorbide Dinitrate with 37 (22%), 24 (14.2%), 23 (13.6%) ADRs respectively. Most common ADR was headache (due to amlodipine and Isosorbide di nitrate) affecting 38 (22.62%) cases followed by dry cough 37 (22.02%) cases, edema feet 36 (21.43%), gastritis 24 (14.29%) and 10 (5.95%) of nausea.Conclusions: Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines are mostly used as multidrug therapy and always prone for ADRs.

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