Emtricitabine Pregnancy and Breastfeeding Warnings
Emtricitabine is also known as: Emtriva
Emtricitabine Pregnancy Warnings
Emtricitabine has been assigned to pregnancy category B by the FDA. The incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures approximately 60-fold higher and in rabbits at approximately 120-fold higher than human exposures at the recommended daily dose. There are no controlled data in human pregnancy. Emtricitabine is only recommended for use during pregnancy when benefit outweighs risk.
To monitor fetal outcomes of pregnant women exposed to emtricitabine, an antiretroviral Pregnancy Registry as been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA).
Emtricitabine Breastfeeding Warnings
Samples of breast milk obtained from 5 HIV-1 infected women showed that emtricitabine is secreted in human milk. Breastfeeding infants whose mothers are being treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown.
Emtricitabine is excreted into human milk. The effects in the nursing infant are unknown. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-1 infected women not to breast-feed to avoid postnatal transmission of HIV-1 to a child who may not yet be infected. The manufacturer recommends that due to the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should not breastfeed while taking emtricitabine.
- Emtricitabine use while Breastfeeding (in more detail)
- emtricitabine Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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 drug information 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 drug combination in no way should be construed to indicate that the drug of drug 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 in 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.