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Safety and Risk of Pharmacotherapy

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The Adverse Drug Reactions Registered During the Postmarketing Period

https://doi.org/10.30895/2312-7821-2019-7-1-15-22

Abstract

Efficacy, safety and biotransformation features of any drug are fully revealed during widely using. Therefore, postmarketing studies of the pharmacological properties of drugs are an integral component of pharmacovigilance. The aim of this study was to evaluate the nature and frequency of drugs adverse reactions that have been reported in the post-marketing period, as well as a review of measures taken by foreign regulatory authorities to ensure the safety of use of these drugs. The results of monitoring the drug safety in the post-marketing period used in clinical practice during various time intervals are presented: from several years (atelizumab, daclizumab) to several decades (valproate, retinoids). The review included data from decisions of regulatory authorities, published in 2018. Recommendations from foreign sources on the rational use of drugs, ways to increase the benefit/risk ratio of adverse reactions when using drugs from different therapeutic groups and/or the need for changes in the instructions on their medical use due to changes in the safety profile are considered. These recommendations will be helpful to healthcare professionals, as well as persons authorized for pharmacovigilance by pharmaceutical companies. Particularly, this information may be of interest to rheumatologists, oncologists, neurologists, psychiatrists, as well as other physicians who use atezolizumab, tocilisumab, daclizumab, pomalidomide, valproate sodium and valproic acid, retinoids, clarithromycin, cotrimaxozol, cefalexine, hydroxycarbamide, ritonavir.

About the Authors

E. V. Shubnikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Cand. Sci. (Med.), Senior Analyst of the Department of Expert Analysis Methodology of the Division for Evaluation of Medicinal Products’ Safety

8/2 Petrovsky Blvd, Moscow 127051


M. A. Darmostukova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Senior Analyst of the Department for Evaluation of MIBPs Side Effects of the Division for Evaluation of Medicinal Products’ Safety

8/2 Petrovsky Blvd, Moscow 127051


T. M. Bukatina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Cand. Sci. (Med.), Senior Analyst of the Department of Expert Analysis Methodology of the Division for Evaluation of Medicinal Products’ Safety

8/2 Petrovsky Blvd, Moscow 127051


D. A. Kaperko
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Senior Analyst of Department of Expert Analysis Methodology of the Division for Evaluation of Medicinal Products’ Safety

8/2 Petrovsky Blvd, Moscow 127051


N. Y. Velts
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Cand. Sci. (Biol.), Assistant Professor, Senior Analyst of the Department of Expert Analysis Methodology of theDivision for Evaluation of Medicinal Products’ Safety

8/2 Petrovsky Blvd, Moscow 127051


A. S. Kazakov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Cand. Sci. (Med.), Leading Analyst of the Department of Expert Analysis Methodology of the Division for Evaluation of Medicinal Products’ Safety

8/2 Petrovsky Blvd, Moscow 127051


I. I. Snegireva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Cand. Sci. (Med.), Head of the Department for Evaluation of MIBPs Side Effects of the Division for Evaluation of Medicinal Products’ Safety

 


E. O. Zhuravleva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Head of the Department for Expert Analysis of Medicinal Products’ Safety of the Division for Evaluation of Medicinal Products’ Safety

8/2 Petrovsky Blvd, Moscow 127051


G. V. Kutekhova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Analyst of the 1st category of the Department for Expert Analysis of Medicinal Products’ Safety of theDivision for Evaluation of Medicinal Products’ Safety

8/2 Petrovsky Blvd, Moscow 127051


References

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Review

For citations:

Shubnikova E.V., Darmostukova M.A., Bukatina T.M., Kaperko D.A., Velts N.Y., Kazakov A.S., Snegireva I.I., Zhuravleva E.O., Kutekhova G.V. The Adverse Drug Reactions Registered During the Postmarketing Period. Safety and Risk of Pharmacotherapy. 2019;7(1):15-22. (In Russ.) https://doi.org/10.30895/2312-7821-2019-7-1-15-22

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This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2312-7821 (Print)
ISSN 2619-1164 (Online)

Publisher: Scientific Centre for Expert Evaluation of Medicinal Products

 

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