ASSESSMENT OF ANENCEPHALY REPORTS ASSOCIATED WITH ANTIRETROVIRAL DRUG EXPOSURE USING THE FAERS DATABASE
Author(s)
NAJAF FAROOQUI, MPH1, Gouri Nair, PhD2, B A. Bharathi, Masters (Pharmacology)3, Ummai Salma, Masters (Pharmacology)3, Spandana Jagadeesh, Masters (Pharmacology)3.
1Postgraduate student, M S Ramaiah University Of Applied Sciences, Bangalore, India, 2M S Ramaiah University Of Applied Sciences, Bengalore, India, 3MS Ramaiah University of Applied Sciences, Bangalore, India.
1Postgraduate student, M S Ramaiah University Of Applied Sciences, Bangalore, India, 2M S Ramaiah University Of Applied Sciences, Bengalore, India, 3MS Ramaiah University of Applied Sciences, 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 preferredterm“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. Threereports 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 preferredterm“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. Threereports 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
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
RWD138
Topic
Clinical Outcomes, Patient-Centered Research, Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
Pediatrics