We searched for clinical trials or cohorts that assessed the incidence of serious adverse reactions to benzathinepenicillin in pregnant women and the general population (indirect evidence). MEDLINE, EMBASE, Scopus and otherdatabases were searched up to Dec 2012. The GRADE approach was used to assess quality of evidence. Absolute risksof each study were calculated along with their 95% confidence intervals (95% CI). We employed the Der Simonian and Laird random effects model in the meta-analyses.
Results:
From 2,765 retrieved studies we included 13, representing 3,466,780 patients. The studies that included pregnant women were conducted to demonstrate the effectiveness of benzathine penicillin no serious adverse reactions were reported among the 1,244 pregnant women included. In the general population, among 2,028,982 patients treated, 4 died from an adverse reaction. The pooled risk of death was virtually zero. Fifty-four cases of anaphylaxis were reported (pooledabsolute risk = 0.002%; 95% CI 0%0.003% I2 = 12%). From that estimate, penicillintreatment would be expected to result in an incidence of 0 to 3 cases of anaphylaxis per 100,000 treated. Any adverse reactions were reported in 6,377 patients among 3,465,322 treated with penicillin (pooled absolute risk = 0.169%; 95% CI 0.073%0.265% I2 = 97%). The quality ofevidence was very low.