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Frovatriptan Pregnancy and Breastfeeding Warnings

Frovatriptan is also known as: Frova

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.

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Frovatriptan Breastfeeding Warnings

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.

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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Frova (frovatriptan)." Endo Laboratories LLC, Chadds Ford, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Frova (frovatriptan)." Endo Laboratories LLC, Chadds Ford, PA.

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