Safety Profile of Levonorgestrel: A Disproportionality Analysis of Food and Drug Administration Adverse Event Reporting System (Faers) Database.

Background: Levonorgestrel is most commonly utilized as an emergency oral contraceptive. Little is known and/or studied about the adverse effects of levonorgestrel, therefore, current investigation was aimed to generate signal for unreported adverse drug reactions of levonorgestrel using disproportionality analysis in food and drug administration adverse events reporting system database.

Methods: In FDA Adverse Events Reporting System (FAERS) database, all adverse event reports for levonorgestrel between January 2006 to June 2015 were identified and disproportionality analysis was conducted for selected adverse events of levonorgestrel using Reporting Odds Ratio, Proportional Reporting Ratio and Information Component with 95% confidence interval.

Results: A disproportionality analysis was done for 15 adverse events of levonorgestrel; out of these, signal for 10 adverse events was found and among them menstruation delayed was reported maximum (1791), followed by pregnancy after post-coital contraception (942), breast tenderness (901), metrorrhagia (899), dysmenorrhea (822), menorrhagia (541), nipple disorder (141), breast enlargement (77), ectopic pregnancy (61) and premenstrual syndrome (35). Pregnancy after post-coital contraception showed the highest signal having the Information Component value of 129.2, Reporting Odds Ratio value of 6.51 and Proportional Reporting Ratio value of 6.49.

Conclusion: In this paper, ten novel AEs were identified that were disproportionately reported with the use of LNG by using data mining techniques. Although a causal relationship cannot be established, the number of cases reported suggests that there might be an association. If confirmed by epidemiologic studies, the findings from this study would have potential implications for the use of LNG and patient management in clinical practice.