Skip to main content
SpringerLink
Log in

Author’s Reply to Joerg Putzke et al. Comment on: “Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database”

  • Letter to the Editor
  • Published:
BioDrugs Aims and scope Submit manuscript

A Letter to the Editor to this article was published on 16 April 2021

The Original Research Article was published on 13 January 2021

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Tanni KA, Truong CB, Almahasis S, Qian J. Safety of marketed cancer supportive care biosimilars in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database. BioDrugs. 2021. https://doi.org/10.1007/s40259-020-00466-3.

    Article  PubMed  Google Scholar 

  2. Putzke J, Haughie S, Zou KH, Ranganna GM. Comment on: “Safety of marketed cancer supportive care biosimilars in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) Database”. BioDrugs. 2021. https://doi.org/10.1007/s40259-021-00476-9.

    Article  PubMed  Google Scholar 

  3. U.S. Food and Drug Administration. Questions and Answers on FDA's Adverse Event Reporting System (FAERS). https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers. Accessed 19 Feb 2021.

  4. U.S. Food and Drug Administration. FAERS Reporting by Patient Outcomes by Year. https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/faers-reporting-patient-outcomes-year. Accessed 19 Feb 2021.

  5. Fukazawa C, Hinomura Y, Kaneko M, Narukawa M. Significance of data mining in routine signal detection: analysis based on the safety signals identified by the FDA. Pharmacoepidemiol Drug Saf. 2018;27(12):1402–8. https://doi.org/10.1002/pds.4672.

    Article  PubMed  Google Scholar 

  6. Gastaldon C, Raschi E, Kane JM, Barbui C, Schoretsanitis G. Post-marketing safety concerns with esketamine: a disproportionality analysis of spontaneous reports submitted to the FDA adverse event reporting system. Psychother Psychosom. 2021;90(1):41–8. https://doi.org/10.1159/000510703.

    Article  PubMed  Google Scholar 

  7. Shalviri G, Mohammad K, Majdzadeh R, Gholami K. Applying quantitative methods for detecting new drug safety signals in pharmacovigilance national database. Pharmacoepidemiol Drug Saf. 2007;16(10):1136–40. https://doi.org/10.1002/pds.1459.

    Article  PubMed  Google Scholar 

  8. Toki T, Ono S. Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: a comparison between consumer reports and healthcare professional reports. J Clin Pharm Ther. 2020;45(3):462–9. https://doi.org/10.1111/jcpt.13086.

    Article  PubMed  Google Scholar 

  9. van der Heijden PG, van Puijenbroek EP, van Buuren S, van der Hofstede JW. On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios. Stat Med. 2002;21(14):2027–44. https://doi.org/10.1002/sim.1157.

    Article  PubMed  Google Scholar 

  10. Bate A, Lindquist M, Orre R, Edwards I, Meyboom R. Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs. Eur J Clin Pharmacol. 2002;58(7):483–90. https://doi.org/10.1007/s00228-002-0484-z.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Health Outcomes Research and Policy, Auburn University Harrison School of Pharmacy, Auburn, Alabama, USA

    Jingjing Qian, Cong Bang Truong & Kaniz Afroz Tanni

Authors
  1. Jingjing Qian
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Cong Bang Truong
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Kaniz Afroz Tanni
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Jingjing Qian.

Ethics declarations

Funding

No financial assistance was used to conduct the study described in the manuscript and/or used to assist with the preparation of the manuscript.

Conflict of interest

No conflicts of interest to report for all authors.

Ethics approval

The original study was granted exemption by the Auburn University institutional review board (IRB).

Consent

Not applicable.

Data availability

The US FDA FAERS data supporting the results reported in the article can be accessed and downloaded from https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Qian, J., Truong, C.B. & Tanni, K.A. Author’s Reply to Joerg Putzke et al. Comment on: “Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database”. BioDrugs 35, 375–377 (2021). https://doi.org/10.1007/s40259-021-00474-x

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40259-021-00474-x

Search

Navigation