Ribavirin Pregnancy and Breastfeeding Warnings

Ribavirin is also known as: Copegus, 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.

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 Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web1)