The Adverse Drug Reactions Registered During the Postmarketing Period

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.

Keywords

• adverse reactions
• postmarketing research
• safety profile
• drugs
• instructions for medical use
• pharmacovigilance