(P-443) Teratogenicity Associated with Antibiotic Therapy; A Disproportionality Analysis in Spontaneous Reporting Database

Location: Poster Gallery-Pharmacovigilance

Presenting Author(s)

Siyad Kalamveettil, MPharm, BPharm

Siyad K V
KOZHIKODE, Kerala, India

Co-Author(s)

VS

Viswam Subeesh

Assistant Professor, Department of Pharmacy Practice, Faculty of Pharmacy, Ramaiah University of Applied Sciences, Bengaluru, India, India

Background: Teratogens can halt the pregnancy or produce a congenital malformation. Teratogenicity drugs can cause abnormal fetal development which is a major health issue. This study aims to detect the possible teratogenicity associated with the antibiotic therapy through disproportionality analysis in FDA Adverse Event Reporting System (FAERS) Database.

Objectives: This study aims to detect the possible teratogenicity associated with the antibiotic therapy through disproportionality analysis in FDA Adverse Event Reporting System (FAERS) Database.

Methods: The case/non-case retrospective observational study design was adopted for this analysis. The publicly available FAERS data was obtained for the analysis of association between teratogenicity and antibiotic therapy. “Exposure During Pregnancy” was the term used to extract reports related to teratogenicity. Reporting odds ratio (ROR) and Proportional Reporting Ratio (PRR) are used as data mining algorithm (DMA) for this analysis. A value of ROR-1.96SE >1 (SE-standard error) and PRR≥2, with an associated χ2 value of 4 or more was considered as threshold for signal. Open vigil 2.1 was used for data extraction and curation.

Results: FAERS Database had a total of 33825 reports for teratogenicity associated with antibiotics. PRR and ROR value for amoxicillin were 3.784 and 3.809 respectively. Similarly, for Ampicillin PRR and ROR were 4.012 and 4.042 respectively. Chloramphenicol had PRR and ROR values of 4.9 and 4.947 respectively. ROR and PRR values for Streptomycin, Kanamycin and Ciprofloxacin were (2.368 and 2,36), (2.44 and 2.452) and (2.643 and 2.653) respectively.

Conclusions: The results showed an association between teratogenicity and 6 Antibiotics. Although a causal relation cannot be proved, the number of cases reported and a significant signal strength of drug-event combination suggests that there might be an association. The findings of this study should be investigated using superior study designs prior to clinical application.