Detection and analysis of signals of adverse events of memantine based on the US food and drug administration adverse event reporting system

ABSTRACT

Background

Despite its widespread use, the adverse effects (AEs) of memantine have not been well documented, and there is a need to find new ways to analyze the AEs of memantine.

Research design and methods

AEs in which the primary suspected drug was memantine were retrieved from the FAERS database. The proportional report ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM) were used to detect potential positive signals between memantine and AEs. SAS, MySQL, EXCEL, and R language software were used for data processing and statistical analysis.

Results

This study gathered a total of 5808 reports of AEs associated with memantine. Of these reports, a greater proportion of female patients (51.17%) than male patients (36.33%) had AEs. The AEs reported by FAERS were mainly in psychiatric category (n = 2157, IC025 = 2.69), various neurologic disorders (n = 1608, IC025 = 2.04), systemic disorders and various site reactions (n = 842, IC025 = 1.29). Unexpected ocular adverse events have been reported, ophthalmic vein thrombosis (n = 4, IC025 = 3.47) and scleral discolouration (n = 7, IC025 = 3.1), which may worsen glaucoma.

Conclusions

This study observed conceivable new AEs signals and may supply important assist for scientific monitoring and threat identification of memantine.

KEYWORDS:

• Adverse effects
• FAERS
• memantine
• pharmacovigilance
• signal mining

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

We are indebted to all the individuals who participated in, or helped with, our research.

Author contributions

Chun Yang, Yikuan Du, Weichui Zhang and Mianhai Chen participated in study conception and design. Xiaolin Cai, Mianda Hu and Mengting Zhang performed data analysis and interpretation. Weichui Zhang, Mianhai Chen, Xiaolin Cai, Mengting Zhang, Mianda Hu, Yanghui Hu and Yurong Yang participated in drafting and/or critical review of the manuscript. All authors gave final approval of the version to be published. All authors agree to be accountable for all aspects of this work.

Ethical consideration

Ethical approval was not required and patient data is anonymized.

Additional information

Funding

This work was supported by Natural Science Foundation of Guangdong Province [(No. 2021A1515011580; 2021B1515140012; 2023A1515010083]; Dongguan Science and Technology of Social Development Program [No. 20211800905342]; the Research and Development Fund of Dongguan People’s Hospital [No. k202005]; Guangdong Medical University Students’ Innovation Experiment Project [No. 2021ZZDS006; 2021ZCDS003; 2022ZYDS003; 2022FYDB009; 2022FCDS003]; the Guangdong Medical University students’ innovation and entrepreneurship training program [No. GDMU2021003; GDMU2021049; GDMU2022031; GDMU2022047; GDMU2022063; GDMU2022077; GDMU2022078]; the Provincial and national college students’ innovation and entrepreneurship training program [No.202210571008; No.S202210571075]; Guangdong Medical University-Southern Medical University twinning research team project [No.4SG23033G]; the Scientific Research Fund of Guangdong Medical University [No. GDMUZ2020009]; and the Cai Limin National Traditional Chinese Medicine Inheritance Studio.