Galvao TF, Silva MT, Serruya SJ, Newman LM, Klausner JD, Pereira MG, Fescina R. Safety of benzathine penicillin for preventing congenital syphilis: a systematic review. PLoS One. 2013;8(2):e56463. doi: 10.1371/journal.pone.0056463. Epub 2013 Feb 21. PubMed PMID: 23437138; PubMed Central PMCID: PMC3578834.
To estimate the risk of serious adverse reactions to benzathine penicillin in pregnant women for preventingcongenital syphilis.
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 December 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 DerSimonian and Lairdrandom effects model in the meta-analyses.
From 2,765 retrieved studies we included 13, representing 3,466,780 patients. The studies that included pregnantwomen were conducted to demonstrate the effectiveness of benzathine penicillin: no serious adverse reactions werereported among the 1,244 pregnant women included. In the general population, among 2,028,982 patients treated, 4 diedfrom 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, penicillin treatment would be expected to result inan incidence of 0 to 3 cases of anaphylaxis per 100,000 treated. Any adverse reactions were reported in 6,377 patientsamong 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.
Studies that assessed the risk of serious adverse events due to benzathine penicillin treatment in pregnantwomen were scarce, but no reports of adverse reactions were found. The incidence of severe adverse outcomes was verylow in the general population. The risk of treating pregnant women with benzathine penicillin to prevent congenital syphilisappears very low and does not outweigh its benefits. Further research is needed to improve the quality of evidence.
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