In my husband's trial were we made to sign a consent agreeing to use 2 forms of birth control throughout the duration of the trial and for six months afterward. They are serious about this, because ribavirin causes birth defects.
******This in no way indicates that I think it is in anyway wise to try and conceive while either partner is on ribavirin. It is a profoundle BAD idea. It is only professional experience*******
Yes and the baby is healthy and beautiful. With regards to ribavrin and sperm, in some respects, the jury is still out. Ribavirin can cause changes in the actual structure of the sperm. The drug is also found in semen. It is unsure whether or not the drug is present within the sperm cell or not. There is a registry of paternal ribavirin pregnancies carried to term and there have been results of successful presnancies.
I'd really love more help on this area. I have 4 months left of treatment (I'm a 30 yr old male) and my wife and I want to have kids soon. We will wait the 6 months to be safe, but I'd love to get some help or examples of other paternal experiences. Has anyone had a bad or good result from pregnancy? First hand experience?
I just found out I am pregnant and my boyfriend only has one month left of ribovarin/pegintron treatment. I want the baby but Im am terrified. can you explain a little more to me about this? Did you get someone pregnant on treatment? I see it says the baby is healthy but it doesnt say whether it was yours and if the father was on treatment or the mother? Please help me to understand. Lindsay.
Here is the information from the package insert for Ribavirin:
Warnings and Precautions
Ribavirin Capsules may cause birth defects and death of the unborn child. Ribavirin therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Patients should use at least two forms of contraception and have monthly pregnancy tests during treatment and during the 6-month period after treatment has been stopped. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin has demonstrated significant teratogenic and embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of ribavirin. Ribavirin therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy [see BOXED WARNING, CONTRAINDICATIONS (4), USE IN SPECIFIC POPULATIONS (8.1), and PATIENT COUNSELING INFORMATION (17.2)].
USE IN SPECIFIC POPULATIONS
Pregnancy Category X
[See CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), and NONCLINICAL TOXICOLOGY (13.1)].
Treatment and Posttreatment
Potential Risk to the Fetus
Ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. It is not known whether ribavirin contained in sperm will exert a potential teratogenic effect upon fertilization of the ova. In a study in rats, it was concluded that dominant lethality was not induced by ribavirin at doses up to 200 mg/kg for 5 days (estimated human equivalent doses of 7.14 to 28.6 mg/kg, based on body surface area adjustment for a 60 kg adult; up to 1.7 times the maximum recommended human dose of ribavirin). However, because of the potential human teratogenic effects of ribavirin, male patients should be advised to take every precaution to avoid risk of pregnancy for their female partners.
Women of childbearing potential should not receive ribavirin unless they are using effective contraception (two reliable forms) during the therapy period. In addition, effective contraception should be utilized for 6 months post-therapy based on a multiple-dose half-life (t1/2) of ribavirin of 12 days.
Male patients and their female partners must practice effective contraception (two reliable forms) during treatment with ribavirin and for the 6 months post-therapy period (e.g., 15 half-lives for ribavirin clearance from the body).
A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Ribavirin may cause Birth Defects or Death of your unborn baby. Do Not Take Ribavirin if you or your sexual partner is pregnant, or plan to become pregnant. Do Not become Pregnant within 6 months after discontinuing ribavirin therapy. You must use 2 forms of birth control when you take ribavirin and for the 6 months after treatment.
Females must have a pregnancy test before starting ribavirin, every month while taking ribavirin, and every month for the 6 months after the last dose of ribavirin.
If you or your female sexual partner becomes pregnant while taking ribavirin, tell your healthcare provider right away. You or your healthcare provider should contact the ribavirin pregnancy registry by calling 1-800-593-2214. The ribavirin pregnancy registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.
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