Safety of Benzathine Penicillin for Preventing Congenital Syphilis: A Systematic Review

Abstract

ObjectiveTo estimate the risk of serious adverse reactions to benzathine penicillin in pregnant women for preventing congenital syphilis.MethodsWe searched for clinical trials or cohorts that assessed the incidence of serious adverse reactions to benzathine penicillin in pregnant women and the general population (indirect evidence). MEDLINE, EMBASE, Scopus and other databases were searched up to December 2012. The GRADE approach was used to assess quality of evidence. Absolute risks of each study were calculated along with their 95% confidence intervals (95% CI). We employed the DerSimonian and Laird random effects model in the meta-analyses.ResultsFrom 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 (pooled absolute risk = 0.002%; 95% CI: 0%–0.003% I2 = 12%). From that estimate, penicillin treatment 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 of evidence was very low.ConclusionStudies that assessed the risk of serious adverse events due to benzathine penicillin treatment in pregnant women were scarce, but no reports of adverse reactions were found. The incidence of severe adverse outcomes was very low in the general population. The risk of treating pregnant women with benzathine penicillin to prevent congenital syphilis appears very low and does not outweigh its benefits. Further research is needed to improve the quality of evidence.

Bipartite Topology of Treponema pallidum Repeat Proteins C/D and I

“…Of great concern, mother-to-child transmission of syphilis occurs in approximately 2 million pregnancies per year, more than any other infectious disease, including human immunodeficiency virus infection (3). These trends have taken root although T. pallidum remains exquisitely sensitive to penicillin G after 7 decades of use (4,5). The inability of epidemiological approaches to curtail the spread of syphilis underscores the need for stratagems based on better knowledge of the molecular biology of its etiologic agent (6).…”

Syphilis testing in antenatal care: Policies and practices among laboratories in the Americas

“…In these cases, sending out a blood sample to a laboratory for a non-treponemal test would support the syphilis diagnosis and the provision of additional treatment for the woman and her partner. This approach would be more cost-effective and have a higher efficacy in protecting the fetus against adverse outcomes [18] while minimizing the risks of syphilis complications for both the patient and her sexual partner [19].…”

Prevenção da sífilis congênita em Fortaleza, Ceará: uma avaliação de estrutura e processo

“…Tal situação é injustificável, uma vez que as reações anafiláticas são raras 31 . Chama a atenção o baixo percentual de unidades com profissionais capacitados em sífilis (21,3%).…”