Paternal Exposure to Ribavirin: Pregnancy and Neonatal Outcome

M, De Santis; Carducci, Brigida; Af, Cavaliere; L, De Santis; Lucchese, Angela; Straface, Gianluca; Caruso, Alessandro

doi:10.1177/135965350300800110

Cited by 17 publications

(1 citation statement)

References 12 publications

(10 reference statements)

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“…15 pregnancies exposed through male sexual contact during clinical trials of ribavirin resulted in two healthy live born infants, four miscarriages, two terminations, and seven with unknown outcome (Maddrey, 1999). A case series of seven cases of peri-conception male exposure resulted in six normal birth outcomes and one miscarriage (De Santis et al, 2003). Two cases of male partner exposure occurring at 5 and 11 months prior to conception resulted in live born infants with no reported birth defects (Hegenbarth et al, 2001), and another case was reported of an infant with no adverse fetal effects following an indirect peri-conception ribavirin exposure (Bianca & Ettore, 2003).…”

Section: Exposure Through Male Sexual Contactmentioning

confidence: 99%

Final results from the ribavirin pregnancy registry, 2004–2020

Sinclair

Jones

Miller

et al. 2022

Birth Defects Research

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Introduction: Significant teratogenic effects have been demonstrated for ribavirin in animal studies. Ribavirin is prescribed for chronic hepatitis C and is contraindicated in pregnant women and their male sexual partners. Both are advised to avoid pregnancy for 6 months after exposure. The registry monitored pregnancy exposures to oral formulations of ribavirin for hepatitis C for signals of possible human teratogenicity from 2004 to 2020. Methods: Pregnant women were voluntarily enrolled following direct exposure (ribavirin use during pregnancy or the 6 months prior) or indirect exposure (through sexual contact during pregnancy or 6 months prior, with a man who has taken ribavirin within 6 months). Women were followed until the end of pregnancy. Infants were followed until 1 year of age. Birth defect rates were compared with the published rate of 2.67 per 100 live births from the Metropolitan Atlanta Congenital Defects Program (MACDP). Results: The registry enrolled 280 pregnancies resulting in 186 live births: eight birth defect cases among 88 directly exposed [9.09% (8/88, 95% CI: 4.01, 17.13)], and six birth defect cases among 98 indirectly exposed [6.12% (6/98, 95% CI: 2.28, 12.85)]. The 95% CI around the birth defect rate among directly exposed pregnancies exceeds the MACDP rate; however, no patterns suggestive of a teratogenic mechanism or safety signal were detected. Conclusion: Based on the patterns of birth defects reported, the final results from this registry do not suggest a clear signal of human teratogenicity for ribavirin. The registry did not meet sample size requirements; therefore, caution should be exercised when interpreting the results.

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Section: Exposure Through Male Sexual Contactmentioning

confidence: 99%

Final results from the ribavirin pregnancy registry, 2004–2020

Sinclair

Jones

Miller

et al. 2022

Birth Defects Research

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The Ribavirin Pregnancy Registry: Findings after 5 years of enrollment, 2003–2009

Roberts

Miller

Jones

et al. 2010

Birth Defects Research

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Current awareness: Pharmacoepidemiology and drug safety

2003

Pharmacoepidemiology and Drug

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of pharmacoepidemiology and drug safety. Each bibliography is divided into 19 sections: 1 Books, Reviews & Symposia; 2 General; 3 Anti‐infective Agents; 4 Cardiovascular System Agents; 5 CNS Depressive Agents; 6 Non‐steroidal Anti‐inflammatory Agents; 7 CNS Agents; 8 Anti‐neoplastic Agents; 9 Haematological Agents; 10 Neuroregulator‐Blocking Agents; 11 Dermatological Agents; 12 Immunosuppressive Agents; 13 Autonomic Agents; 14 Respiratory System Agents; 15 Neuromuscular Agents; 16 Reproductive System Agents; 17 Gastrointestinal System Agents; 18 Anti‐inflammatory Agents ‐ Steroidal; 19 Others. Within each section, articles are listed in alphabetical order with respect to author. If, in the preceding period, no publications are located relevant to any one of these headings, that section will be omitted.

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Paternal Exposure to Ribavirin: Pregnancy and Neonatal Outcome

Abstract: We report seven cases of newborns conceived within 6 months from the end or during paternal ribavirin exposure.

Cited by 17 publications

References 12 publications

Final results from the ribavirin pregnancy registry, 2004–2020

Final results from the ribavirin pregnancy registry, 2004–2020

The Ribavirin Pregnancy Registry: Findings after 5 years of enrollment, 2003–2009

Current awareness: Pharmacoepidemiology and drug safety

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