Tamiflu Use In Pregnancy & Lactation

Females & Males of Reproductive Potential: Fertility: Fertility studies have been conducted in rats. There was no evidence of an effect on male or female fertility at any dose of oseltamivir studied. See Pharmacology: Toxicology: Nonclinical Safety: Impairment of Fertility under Actions.
Pregnancy: Risks to the Developing Embryo/Fetus and to the Mother: In animal reproductive studies in rats and rabbits, no teratogenic effect was observed. Foetal exposure in rats and rabbits was approximately 15-20% of that of the mother.
No controlled clinical trials have been conducted on the use of oseltamivir in pregnant women; however, there is evidence from post-marketing and observational studies showing benefit of the current dosing regimen in this patient population. Results from pharmacokinetic analyses indicate a lower exposure to the active metabolite, however dose adjustments are not recommended for pregnant women in the treatment or prophylaxis of influenza (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions). A large amount of data from pregnant women exposed to oseltamivir (more than 1000 exposed outcomes during the first trimester) from post-marketing reports and observational studies in conjunction with animal studies (see Pharmacology: Toxicology: Nonclinical Safety under Actions) indicate no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal or postnatal development. Pregnant women may receive Tamiflu, after considering the available safety and benefit information, the pathogenicity of the circulating influenza virus strain and the underlying condition of the pregnant woman.
Labor and Delivery: The safe use of oseltamivir during labor and delivery has not been established.
Lactation: In lactating rats, oseltamivir and the active metabolite are excreted in the milk. Very limited information is available on children breast-fed by mothers taking oseltamivir and on excretion of oseltamivir in breast milk. Limited data demonstrated that oseltamivir and the active metabolite were detected in breast milk; however, the levels were low, which would result in a sub-therapeutic dose to the infant. Based on this information, the pathogenicity of the circulating influenza virus strain and the underlying condition of the lactating woman, administration of oseltamivir may be considered.