Assessing ribavirin exposure during pregnancy: the Ribavirin Pregnancy Registry.
Ribavirin, used in combination with an interferon, is used for the treatment of chronic hepatitis C. Ribavirin is a Federal Drug Administration Pregnancy Category X product, indicating that its use is contraindicated in women who are pregnant. The package insert also states that ribavirin is contraindicated in men whose partners may become pregnant. The Ribavirin Pregnancy Registry operates in the United States and actively monitors pregnancy exposures to ribavirin. The registry evaluates the association between ribavirin exposures during pregnancy or within 6 months after treatment is stopped. Participation in the registry is voluntary. The registry relies on patients and healthcare providers to provide exposure and pregnancy outcome data to the registry. Despite patient education and counseling, ribavirin-exposed pregnancies occur. Understanding more about the risk of ribavirin exposure in human pregnancy is critical. Nurses are vital to the success of the registry. Until the registry enrolls adequate numbers of patients, obtaining answers to questions about the safety of ribavirin in pregnancy will be delayed. Every exposed pregnancy that is not enrolled in the registry is a missed opportunity to further our knowledge about the risk of ribavirin exposure during pregnancy.
Roberts
Susan Sinclair
SS
Ribavirin Pregnancy Registry Coordinating Center at Kendle International, Inc., Wilmington, NC, USA. robertss@uncw.edu
D000328:Adult; D000818:Animals; D005260:Female; D005865:Gestational Age; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D024802:Nurse's Role; D010353:Patient Education as Topic / Q000379:methods*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control*; D018566:Pregnancy, High-Risk; D011295:Prenatal Care / Q000379:methods; D012042:Registries; D012254:Ribavirin / Q000009:adverse effects* / Q000627:therapeutic use; D014481:United States; D055815:Young Adult
D012254:Ribavirin