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. 2022 Nov 29:13:1044744.
doi: 10.3389/fphar.2022.1044744. eCollection 2022.

Drug-induced fall risk in older patients: A pharmacovigilance study of FDA adverse event reporting system database

Shuang Zhou  1 , Boying Jia  2 , Jiahe Kong  3 , Xiaolin Zhang  4 , Lili Lei  1 , Zhenhui Tao  5 , Lingyue Ma  1 , Qian Xiang  1 , Ying Zhou  1 , Yimin Cui  1   6
Affiliations

Drug-induced fall risk in older patients: A pharmacovigilance study of FDA adverse event reporting system database

Shuang Zhou et al. Front Pharmacol. .

Abstract

Objectives: As fall events and injuries have become a growing public health problem in older patients and the causes of falls are complex, there is an emerging need to identify the risk of drug-induced falls. Methods: To mine and analyze the risk signals of drug-induced falls in older patients to provide evidence for drug safety. The FDA Adverse Event Reporting System was used to collect drug-induced fall events among older patients. Disproportionality analyses of odds ratio (ROR) and proportional reported ratio were performed to detect the adverse effects signal. Results: A total of 208,849 reports (34,840 fall events and 1,898 drugs) were considered. The average age of the included patients was 76.95 ± 7.60 years, and there were more females (64.47%) than males. A total of 258 drugs with positive signals were detected to be associated with drug-induced fall incidence in older patients. The neurological drugs (104, 44.1%) with the largest number of positive detected signals mainly included antipsychotics, antidepressants, antiparkinsonian drugs, central nervous system drugs, anticonvulsants and hypnotic sedatives. Other systems mainly included the circulatory system (25, 10.6%), digestive system (15, 6.4%), and motor system (12, 5.1%). Conclusion: Many drugs were associated with a high risk of falls in older patients. The drug is one of the critical and preventable factors for fall control, and the risk level of drug-induced falls should be considered to optimize drug therapy in clinical practice.

Keywords: ADR; FARES; older patients; pharmacovigilance; risk of drug-induced falls.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Flow chart for identification of fall reports of suspected adverse events FAERS, FDA Adverse Event Reporting System; ADEs, Adverse Drug Events.
FIGURE 2
FIGURE 2
Characteristics of patients and ADEs reports included in the analysis (A) the age and sex distribution of included patients, (B) the number of ADEs reported per year, (C) the outcomes of included patients.
FIGURE 3
FIGURE 3
The number of drugs with positive signals detected for each physiological system.
FIGURE 4
FIGURE 4
ROR for fall of each physiological system.
FIGURE 5
FIGURE 5
RORs for fall with positive signals detected drugs (A) antipsychotic drugs, (B) antidepressant drugs, (C) antiparkinsonian drugs, (D) central nervous system drugs, (E) hypnotic sedative drugs, (F) anticonvulsive drug, (G) antihypertensive drugs.
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