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Ribavirin Pregnancy and Breastfeeding Warnings

Ribavirin is also known as: Copegus, Moderiba, Rebetol, RibaPak, RibaTab, Ribasphere, Virazole

Ribavirin Pregnancy Warnings

Ribavirin has been assigned to pregnancy category X by the FDA. Nearly all animal studies have revealed evidence of embryolethality and teratogenicity. There are no controlled data in human pregnancies. One published case reports the uneventful use of ribavirin at 33 weeks gestation. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Female patients receiving ribavirin and the partners of male patients receiving ribavirin must avoid pregnancy, using at least two reliable forms of contraception, during treatment and for 6 months after completion of treatment. To monitor maternal-fetal outcomes of pregnant women or female partners of male patients exposed to ribavirin, a Ribavirin Pregnancy Registry has been established. Healthcare providers are encouraged to register patients by calling 1-800-593-2214 (USA).

The manufacturer recommends the use of at least two reliable forms of effective contraception during treatment with ribavirin and during the 6 months after completion of treatment. A negative pregnancy test should be obtained immediately before the planned start of therapy. Health personnel and visitors who are pregnant or trying to become pregnant should also avoid contact with aerosolized ribavirin until more information is available. In one adverse drug report, 3 nurses who worked in the same intensive care unit gave birth to babies with ventricular septal defects. However, only one mother was possibly exposed to ribavirin 5 months prior to estimated conception. A specific causal relationship has not been established.

See references

Ribavirin Breastfeeding Warnings

There are no data on the excretion of ribavirin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. Kirshon B, Faro S, Zurawin RK, Samo TC, Carpenter RJ "Favorable outcome after treatment with amantadine and ribavirin in a pregnancy complicated by influenza pneumonia: a case report." J Reprod Med 33 (1988): 399-401
  2. Hegenbarth K, Maurer U, Kroisel PM, Fickert P, Trauner M, Stauber RE "No evidence for mutagenic effects of ribavirin: Report of two normal pregnancies." Am J Gastroenterol 96 (2001): 2286-7
  3. Janai HK, Marks MI, Zaleska M, Stutman HR "Ribavirin: adverse drug reactions, 1986 to 1988." Pediatr Infect Dis J 9 (1990): 209-11
  4. Harrison R, Bwllows J, Rempel D, et al. "Assess esposures of health-care personnel to aerosols of ribavirin--California." MMWR Morb Mortal Wkly Rep 37 (1988): 560-2
  5. "Product Information. Virazole (ribavirin)." ICN Pharmaceuticals Inc, Cost Mesa, CA.

References for breastfeeding information

  1. "Product Information. Copegus (ribavirin)." Roche Laboratories, Nutley, NJ.
  2. "Product Information. Virazole (ribavirin)." ICN Pharmaceuticals Inc, Cost Mesa, CA.

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