Frovatriptan Pregnancy and Breastfeeding Warnings
Brand names: Frova
Medically reviewed by Drugs.com. Last updated on Aug 12, 2024.
Frovatriptan Pregnancy Warnings
Benefit should outweigh risk
Comment: Use of adequate methods of contraception should be encouraged.
US FDA pregnancy category: C
Pregnant rats administered this drug during the period of organogenesis at oral doses equivalent to 130 to 1,300 times the maximum recommended human dose had dose related increased incidences of fetuses with dilated ureters, unilateral and bilateral pelvic cavitation, hydronephrosis, and hydroureters. When pregnant rabbits were dosed throughout organogenesis at doses up to 210 times the maximum recommended human dose, no effects on fetal development were observed. There are no controlled data in human pregnancy.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Frovatriptan Breastfeeding Warnings
Breastfeeding is not recommended for 24 hours after taking this drug
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comment: If this drug is clearly needed, patients should be instructed to avoid breastfeeding for 24 hours after taking this drug.
In rats, levels of this drug and/or its metabolites were up to 4 times higher in milk than in plasma. As its half-life is longer (25 to 30 hours) than most other triptans, a shorter-acting triptan may be preferred, especially while nursing a newborn or preterm infant.
See also
References for pregnancy information
- (2001) "Product Information. Frova (frovatriptan)." Endo Laboratories LLC
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
References for breastfeeding information
- (2001) "Product Information. Frova (frovatriptan)." Endo Laboratories LLC
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.