FAERS DATABASE ANALYSIS REVEALS ANENCEPHALY ASSOCIATED WITH ANTIRETROVIRAL DRUG EXPOSURE
Author(s)
NAJAF FAROOQUI, Masters (Pharmacology)1, Gouri Nair, PhD1, Spandana Jagadeesh, Masters (Pharmacology)2, B. A. Bharathi, Masters (Pharmacology)2, Ummai Salma, Masters (Pharmacology)2;
1M S Ramaiah University Of Applied Sciences, Pharmacology, Bangalore, India, 2MS Ramaiah University of Applied Sciences, Pharmacology, Bangalore, India
1M S Ramaiah University Of Applied Sciences, Pharmacology, Bangalore, India, 2MS Ramaiah University of Applied Sciences, Pharmacology, Bangalore, India
OBJECTIVES: To identify potential safety signals for anencephaly associated with ARAs using disproportionality analysis of data from the FAERS database.
METHODS: A retrospective case/non-case disproportionality analysis was conducted using FAERS data using OpenVigil 2.1. Reports containing the preferred term “Anencephaly” were extracted for all ARAs and fixed-dose combinations (FDCs). Reporting Odds Ratios (RORs) with 95% confidence intervals (CIs) were calculated. A signal was considered present if the lower bound of the 95% CI exceeded 1.
RESULTS: Among 557 anencephaly reports, 79 were associated with ARAs. The median age of patients was 32 years (IQR: 24-35). Emtricitabine had the highest number of reports (n=51), followed by Ritonavir (n=32) and Tenofovir (n=28). Among FDCs, Emtricitabine/Tenofovir accounted for the highest number of reports (n=38). The overall signal strength for the ARAs class was ROR=12.229; 95% CI: 9.638-15.516. Seventeen ARAs and 2 ARA FDCs showed a potential safety signal. Tipranavir showed the strongest signal (551.688; 343.42-886.26), followed by Etravirine (97.723; 50.453-189.28) and Enfuvirtide (97.684; 48.489-196.789). Among FDCs, Lamivudine and Zidovudine (87.799; 50.529-152.56) had the highest signal. Twenty-nine other congenital abnormalities were associated with ARAs, with spina bifida (n=31), neural tube defect (n=30), and meningomyelocele (n=29) being the most frequently reported after anencephaly. Three reports each of abortion and stillbirth, with 35 (44%) deaths and 17 (22%) life-threatening outcomes reported for anencephaly.
CONCLUSIONS: This study highlights a potential safety concern regarding the association between antiretroviral agents and anencephaly. Continued pharmacovigilance and targeted epidemiological studies are warranted to further investigate and mitigate these risks in vulnerable populations.
METHODS: A retrospective case/non-case disproportionality analysis was conducted using FAERS data using OpenVigil 2.1. Reports containing the preferred term “Anencephaly” were extracted for all ARAs and fixed-dose combinations (FDCs). Reporting Odds Ratios (RORs) with 95% confidence intervals (CIs) were calculated. A signal was considered present if the lower bound of the 95% CI exceeded 1.
RESULTS: Among 557 anencephaly reports, 79 were associated with ARAs. The median age of patients was 32 years (IQR: 24-35). Emtricitabine had the highest number of reports (n=51), followed by Ritonavir (n=32) and Tenofovir (n=28). Among FDCs, Emtricitabine/Tenofovir accounted for the highest number of reports (n=38). The overall signal strength for the ARAs class was ROR=12.229; 95% CI: 9.638-15.516. Seventeen ARAs and 2 ARA FDCs showed a potential safety signal. Tipranavir showed the strongest signal (551.688; 343.42-886.26), followed by Etravirine (97.723; 50.453-189.28) and Enfuvirtide (97.684; 48.489-196.789). Among FDCs, Lamivudine and Zidovudine (87.799; 50.529-152.56) had the highest signal. Twenty-nine other congenital abnormalities were associated with ARAs, with spina bifida (n=31), neural tube defect (n=30), and meningomyelocele (n=29) being the most frequently reported after anencephaly. Three reports each of abortion and stillbirth, with 35 (44%) deaths and 17 (22%) life-threatening outcomes reported for anencephaly.
CONCLUSIONS: This study highlights a potential safety concern regarding the association between antiretroviral agents and anencephaly. Continued pharmacovigilance and targeted epidemiological studies are warranted to further investigate and mitigate these risks in vulnerable populations.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
RWD128
Topic
Real World Data & Information Systems
Disease
SDC: Pediatrics, STA: Multiple/Other Specialized Treatments