Nonmenstrual adverse events associated with subdermal contraceptive implants containing normegestrel and Ievonorgestrel

Abstract

To improve counselling information to Nigerian family planning clients, we compared non-menstrual events reported by 248 Norplant"*' users and 214 Uniplant(R) users. Women using Norplant were significantly older and of higher parity and greater contraceptive experience than Uniplant users. Other admission characteristics of the two groups were similar. The total women - months of use of Norplant was 2,946 (mean 11.9 + 0.6 SE) months while that for Uniplant was 2,315 (mean 10.8 ± 0.2 SE) months. About 36% of Norplant users and 15% of Uniplant users reported non-menstrual adverse events, the commonest ones being pain/itching at the insertion site, unexplained low abdominal pains and clinically diagnosed pelvic inflammatory disease (PID). The numbers of women reporting drug-related adverse events were 61 (24.6%) and 23 (10.8%), respectively, among Norplant and Uniplant users. Drug-related serious adverse events were reported by 3 (1.2%) Norplant users and 5 (2%) Uniplant users. The adverse events leading to Uniplant removal were severe urticaria, breast lumps, pruritus vulvae, headache with raised blood pressure, adnexal pains and ovarian cysts, and static weight while those leading to Norplant removal were breast lump and headache with raised blood pressure. Weight gain was reported by only 7 (3%) of Norplant users. Although of no serious clinical consequences, drug-related adverse events should be added to the counselling information to prospective users.