A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)

Lorenzo Villa-Zapata, Ainhoa Gómez-Lumbreras, John Horn, Malinda S. Tan, Richard D. Boyce and Daniel C. Malone ()
Additional contact information
Lorenzo Villa-Zapata: Mercer University
Ainhoa Gómez-Lumbreras: University of Utah
John Horn: University of Washington
Malinda S. Tan: University of Utah
Richard D. Boyce: University of Pittsburgh
Daniel C. Malone: University of Utah

Drug Safety, 2022, vol. 45, issue 8, No 4, 863-871

Abstract: Abstract Introduction Tizanidine is primarily metabolized via cytochrome P450 (CYP) 1A2 and therefore medications that inhibit the enzyme will affect the clearance of tizanidine, leading to increased plasma concentrations of tizanidine and potentially serious adverse events. Objectives Our aim was to study the occurrence of adverse events reported in the FDA Adverse Event Reporting System (FAERS) involving the combination of tizanidine and drugs that inhibit the metabolic activity of CYP1A2. Methods A disproportionality analysis of FAERS reports from 2004 quarter 1 through 2020 quarter 3 was conducted to calculate the reporting odds ratio (ROR) of reports mentioning tizanidine in a suspect or interacting role or having any role, a CYP1A2 inhibitor, and the following adverse events: hypotension, bradycardia, syncope, shock, cardiorespiratory arrest, and fall or fracture. Results A total of 89 reports were identified mentioning tizanidine, at least one CYP1A2 inhibitor, and one of the adverse events of interest. More than half of the reports identified tizanidine as having a suspect or interacting role (n = 59, 66.3%), and the reports more frequently involved women (n = 58, 65.1%). The median age was 56.1 years (standard deviation 17.1). Some of the important safety signals included interactions between tizanidine in a suspect or interacting role and ciprofloxacin (ROR for hypotension 28.1, 95% confidence interval [CI] 19.2–41.2) or fluvoxamine (ROR for hypotension 36.9, 95% CI 13.1–103.4), and also when reported in “any role” with ciprofloxacin (ROR for hypotension 6.3, 95% CI 4.7–8.5), fluvoxamine (ROR for hypotension 11.4, 95% CI 4.5–28.8), and zafirlukast (ROR for falls 16.0, 95% CI 6.1–42.1). Conclusions Reports involving tizanidine and a CYP1A2 inhibitor have higher odds of reporting hypotension. This study suggests that concurrent use of tizanidine with CYP1A2 inhibitors may lead to serious health consequences associated with low blood pressure such as falls and fractures.

Date: 2022
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
http://link.springer.com/10.1007/s40264-022-01200-4 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:45:y:2022:i:8:d:10.1007_s40264-022-01200-4

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-022-01200-4

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().