The COVID-19 pandemic had disrupted the global healthcare ecosystem. To battle this, numerous treatment methods were attempted (WHO, 2022; EMA, 2023; US FDA, 2023). Although a few new medicines were introduced, a majority of the medicines to treat COVID-19 are repurposed ones. Despite lacking adequate safety data, certain medicines were granted emergency use authorizations. Likewise, several COVID-19 vaccines have been developed and widely used globally (CDC, 2023). As the severity of the COVID-19 pandemic has now reduced globally, optimizing medication management in COVID-19 is crucial and it is necessary to discontinue the use of ineffective medicines (Abdool Karim et al., 2022). It is important to conduct a large-scale evaluation of the safety profile of COVID-19 medicines, as well as vaccines (Chiu et al., 2022). This issue has been dedicated to the safety aspects of pharmacotherapy for COVID-19.
Merino et al. aimed to investigate the potential link between the development of transient global amnesia following the administration of COVID-19 vaccines. The World Health Organization VigiBase® database was consulted for all reports of transient global amnesia. Although cerebrovascular, inflammatory, or migrainous mechanisms might underlie this association, the causality could not be ascertained. Significant disproportionality was noticed and the role of several confounding factors could not be nullified.
Jeong et al. conducted a discovery-driven data analysis using the United States Food and Drugs Administration Adverse Event Reporting System database to identify potential drug-drug interactions due to the use of multiple medications in COVID-19 patients and associated adverse events. Remdesivir was discovered to interact with the largest number of concomitant medicines, while hydroxychloroquine was detected to be associated with the most adverse events. The results warrant further large-scale pharmacoepidemiological studies.
Nishimura et al. used an international network of large-scale healthcare databases (electronic health records from Spain and the United States) to generate comprehensive real-world evidence on the role of alpha-1 blockers in preventing COVID-19 complications by minimizing cytokine storm release. Using a meta-analytic approach, the authors demonstrated that there was no evidence of the hypothesized reduction in risks of COVID-19 outcomes from the prevalent use of alpha-1 blockers.
Pineda et al. evaluated the effect of adjunct fluvoxamine treatment along with the standard of care in COVID-19 patients in a prospective observational study in Honduras. A total of 657 COVID-19 outpatients received adjunct fluvoxamine treatment and were monitored for 30 days. The results suggested that adjunct fluvoxamine lowered the relative risk of death, hospitalization, and oxygen requirement in COVID-19 patients.
Amponsah et al. reviewed the current data on the safety of anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids) in COVID-19 management. The review suggests that methylprednisolone, dexamethasone, and ibuprofen could reduce the mortality rate in hospitalized COVID-19 patients. Non-steroidal anti-inflammatory drugs and corticosteroids do not increase the risk of COVID-19 infections and are not associated with adverse outcomes in COVID-19.
Vaccines and medicines to prevent and treat COVID-19 are still evolving. Numerous studies have been completed within a short timeframe (WHO, 2022; EMA, 2023; US FDA, 2023), thereby limiting the detailed safety evaluations of investigational medicines. Hence, it is essential to collect robust short- and long-term safety data for all these medicines. Consideration of the safety concerns in the context of individual and specific stages of the disease is important to formulate a treatment plan. During the pre-clinical development stage, it is necessary to conduct mechanistic studies, develop biomarkers, and perform toxicokinetic modeling of COVID-19 medicines. Likewise, in the vaccine landscape, ensuring an effective and safe vaccination strategy for COVID-19 could be an ideal way to achieve herd immunity (Poland et al., 2020). Hence, it is also important to investigate short- and long-term adverse effects after COVID-19 vaccination. After regulatory approval, a real-world pragmatic approach is required to address the safety aspects of COVID-19 medicines and vaccines. Randomized database studies, chart reviews, claims data, administrative data analyses, computer monitoring, direct care observations, and other pharmacovigilance studies can serve the purpose.
Statements
Author contributions
SD has drafted the whole article.
Conflict of interest
The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
References
1
Abdool KarimS. S.DevnarainN. (2022). Time to stop using ineffective covid-19 drugs. N. Engl. J. Med.387 (7), 654–655. 10.1056/NEJMe2209017
2
Centers for Disease Control and Prevention (2023). Centers for disease control and prevention. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html (accessed February 21, 2023).
3
ChiuM. N.BhardwajM.SahS. P. (2022). Safety profile of COVID-19 drugs in a real clinical setting. Eur. J. Clin. Pharmacol.78 (5), 733–753. 10.1007/s00228-021-03270-2
4
European Medicines Agency (EMA) (2022). Treatments and vaccines for COVID-19. Available at: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines-covid-19 (accessed February 21, 2023).
5
PolandG. A.OvsyannikovaI. G.KennedyR. B. (2020). SARS-CoV-2 immunity: Review and applications to phase 3 vaccine candidates. Lancet396 (10262), 1595–1606. 10.1016/S0140-6736(20)32137-1
6
United States Food and Drugs Administration (US FDA) (2023). Coronavirus (COVID-19) | drugs (2022). Available at: https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs (accessed February 21, 2023).
7
World Health Organization (WHO). Therapeutics and COVID-19, (2022). Available at: https://www.who.int/publications/i/item/WHO-2019-nCoV-therapeutics-2022.3 (accessed 21 February 2023).
Summary
Keywords
COVID-19, medication, pharmacovigilance, safety, vaccine
Citation
Das S (2023) Editorial: Medication safety in COVID-19 management, Volume II. Front. Pharmacol. 14:1175152. doi: 10.3389/fphar.2023.1175152
Received
27 February 2023
Accepted
03 March 2023
Published
09 March 2023
Volume
14 - 2023
Edited and reviewed by
Anick Bérard, Montreal University, Canada
Updates
Copyright
© 2023 Das.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Saibal Das, saibal.das@icmr.gov.in
This article was submitted to Pharmacoepidemiology, a section of the journal Frontiers in Pharmacology
Disclaimer
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.