FDA Pregnancy
Registry Brochure

Judith K. Jones, MD, PhD, FISPE
President, CEO
The Degge Group Ltd.
Dear Health Care Providers,

Chronic hepatitis C infection is a serious worldwide medical problem which, if left untreated, may advance to end-stage liver disease, primary liver cancer, and death. Therapy with ribavirin combined with unmodified or pegylated interferon alpha has significantly increased both viral clearance, as measured by sustained virological response rates as well as liver biopsy improvement, in patients with chronic hepatitis C.

However, because ribavirin is teratogenic in all animal models tested, potential birth defects following exposure to ribavirin during pregnancy are a concern. Ribavirin is designated FDA Pregnancy Category X. Despite product label warnings against becoming pregnant if the woman or her partner is taking ribavirin, pregnancies continue to occur in women exposed to ribavirin, and insufficient data are available to counsel them regarding the risk from exposure.

The Ribavirin Pregnancy Registry is designed to gather prospective data on ribavirin exposure in pregnancy and pregnancy outcomes to evaluate the risk to pregnant women and their offspring. The Registry is a post-marketing commitment to the FDA from the manufacturers of ribavirin. The Registry enrolls pregnant women who have been inadvertently exposed to Ribavirin either directly (6 months before or during pregnancy) or indirectly (through her male sexual partner 6 months before or during pregnancy). The Registry follows the pregnancies to outcome and live births for one year to detect major congenital malformations in this population.

Because enrollment has not yet gleaned sufficient exposed cases, we need to gather more data to fully answer questions on various aspects of the safety of ribavirin in pregnancy. We urgently need the assistance of our colleagues in hepatology, gastroenterology, infectious disease, primary care medicine, obstetrics, and pediatrics to ensure the Registry’s success through encouraging enrollment of all eligible patients exposed to ribavirin. The Board strongly encourages colleagues to prospectively enroll these individuals with pregnancy exposures to ribavirin (ideally before the outcome of the pregnancy is known) in the Registry as early in pregnancy as possible. The Registry can be contacted through this website ( or by phone (800-593-2214).

My colleagues and I on the Registry Board Executive Committee and those managing and supporting the registry encourage you to use the resources on this website. Please feel free to print and distribute the Registry Announcement click here. Slides describing the Registry are available and can be downloaded for your use: click here. Finally, if you are aware of any organizations who would be interested in working with us by sending an email about the Registry to their members, please contact the registry by email ( or by phone (800-593-2214).

Thank you very much for helping to make this Registry a growing repository of important and useful information on the effects of ribavirin in pregnancy!

Judith K. Jones M.D., Ph.D.
Board Executive Committee Chair (January 2009 – present)

Copyright © 2005
All rights reserved
INC Research