PHARMACOVIGILANCE STUDY OF SIDE EFFECTS ASSOCIATED WITH LEVONORGESTROL -ETHINYL ESTRADIOL AND DEPOTMEDROXY PROGESTERONE ACETATE

Abstract

Background: Levonorgestrol & Ethinyl estradiol (COCs) and Depotmedroxy progesterone acetate (Depo-Provera) are commonly prescribed contraceptives by family planning centers in Pakistan and compliance to these agents is reducing day by day due to associated side effects.

 Objective: Monitoring side effects associated with the use of hormone replacement therapy in contraception.

 Method: It was a population based retrospective study of 1149 cases, maintained on these contraceptives for minor side effects (nausea, vomiting, hair loss and weight gain) and were divided into, groups receiving Drug-I i.e. COCs (n=365; 45.9%) and  Drug-II Depo-Provera (n=431; 54.1%). The occurrence of side effects were correlated with Age I (19-35 years) and Age II (36-50 years), and Duration I (6months-1 year) and Duration-II (1-2 years).

 Results: Women receiving Drug-I (n=365) were more likely to show nausea than Drug-II, [OR= 1.26; 95% CI, 1.17-1.37]. The odd of vomiting of Drug-I was 1.83 times greater than Drug-II [95% CI, 1.62-2.10], vomiting was found more related with Age I, [OR=1.46; 95% CI, 1.100-1.942] and the risk of vomiting was high in Duration-I [OR= 3.32; 95% CI, 2.46-4.48]. Drug-I showed more hair loss than Drug-II, [OR=2.36; 95% CI, 2.27-3.49], and hair loss was found more associated with Age II [OR=1.932; 95% CI, 0.776-1.371], but its relation with duration and age was insignificant (p>0.05).The likelihood of weight gain was found more with Drug-II, Age I and Duration II at 95% CI with OR of 2.36, 2.88 and 1.431 (p<0.05) respectively.

 Conclusion: The most commonly observed side effects with COCs were nausea, vomiting and hair loss, whereas weight gain was found more associated with Depo-Provera.