FDA Pregnancy
Registry Brochure
• Patient Confidentiality and Privacy
The Registry is very concerned with protection of patient confidentiality and privacy. This Registry was established with the collaboration of FDA as a post-marketing commitment and has received IRB (Institutional Review Board) approval for its protocol. The Registry is an extension of safety surveillance of ribavirin exposures in pregnancy.
• Who May Provide Information to the Registry
The Registry collects information from patients and health care providers, i.e.,
• From pregnant patients who have received ribavirin while pregnant or during 6 months after treatment has stopped, or who were exposed to ribavirin through their male sexual partner treated with ribavirin while she was pregnant or during 6 months after he had stopped treatment
• From male sexual partners who have been treated with ribavirin and whose pregnant partner was exposed while he was on treatment or during the 6 months after treatment was stopped
• From providers who prescribed ribavirin, obstetric providers, or genetic counselors who become aware of a pregnancy exposure to ribavirin
• Pediatric providers who can provide information on the live born infant following an in-utero exposure to ribavirin
• How Can Information be Provided
• Information can be provided by phone or the data forms may be completed.
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