Oseltamivir Pregnancy and Breastfeeding Warnings
Oseltamivir is also known as: Tamiflu
Oseltamivir Pregnancy Warnings
Oseltamivir has been assigned to pregnancy category C by the FDA. Animal data, in which doses equivalent to 2 to 100 times the maximum recommended human dose (MRHD) were given, have revealed that the drug crosses the placenta. These data have also revealed maternal toxicity (slight at lower doses, marked at higher doses) and a dose-dependent increase in the incidence of a variety of minor skeletal abnormalities and variants in the exposed offspring. There are no data (controlled or anecdotal) from human pregnancy. Oseltamivir should only be given during pregnancy when benefit outweighs risk.
Oseltamivir Breastfeeding Warnings
Oseltamivir and its active metabolite are excreted into human milk. The effects in the nursing infant are unknown. The manufacturer recommends that oseltamivir should be used only if the potential benefit for the lactating mother justifies the potential risk to the breastfed infant.
A woman who was breastfeeding her 9-month-old infant was treated with oseltamivir 75 mg twice a day for 5 days after accidentally sticking herself with a needle contaminated with 2009 H1N1 influenza virus. Breastfeeding was stopped during this time due to possible side effects in the infant. Eleven milk samples were collected twice daily over the 5-day period by completely emptying both breasts. The sample timing varied, with 8 of the samples collected 30 minutes before or after a dose. The steady-state concentration of the metabolite was reached after 3 days and averaged 37 to 39 ng/mL. The maximum relative infant dose (oseltamivir plus metabolite) was estimated to be 0.012 mg/kg/day, or about 0.5% of the mother's weight-adjusted dose (assuming 60 kg body weight). Based on this study, the concentration of the drug in breast milk appears to be clinically insignificant. Also, the potential dose for a nursing infant is much less than the pediatric dose. Additionally, the Centers for Disease Control and Prevention recommend women infected with 2009 H1N1 influenza virus breastfeed, regardless of whether they are being treated, due to the advantages of breast milk for the infant's immune system.
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.