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Formoterol Pregnancy and Breastfeeding Warnings

Formoterol is also known as: Foradil Aerolizer, Perforomist

Formoterol Pregnancy Warnings

Animal reproduction studies in rats and rabbits revealed evidence of teratogenicity as well as other developmental toxic effects. Oral doses equal to or greater than 80 times the maximum recommended human adult dose (MRHD) caused delayed ossification of the fetus and doses equal to or greater than 2400 times the MRHD for adults caused decreased fetal weight. This drug has been shown to cause stillbirth and neonatal mortality at oral doses equal to or greater than 2400 times the MRHD for adults in rats receiving the drug during the late stage of pregnancy; these effects, however, were not produced at a dose equal to 80 times the MRHD. Umbilical hernia was observed in rat fetuses at oral doses equal to or greater than 1200 times the MRHD for adults. Brachygnathia, a skeletal malformation, was observed for rat fetuses at an oral dose equal to 6100 times the MRHD for adults. Subcapsular cysts on the liver were observed for rabbit fetuses at an oral dose equal to 49000 times the MRHD for adults. No teratogenic effects were observed at oral doses up to 3000 times the MRHD for adults. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comment: -Beta-agonists, including this drug, may potentially interfere with uterine contractility due to a relaxant effect on uterine smooth muscle.

See references

Formoterol Breastfeeding Warnings

Caution is recommended. Benefit should outweigh risk. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -Women should contact their physician if they are nursing while taking the inhalation solution. -The effects in the nursing infant are unknown.

This drug and its metabolites was excreted in the breast milk of lactating rats given oral doses of 50 mcg/kg, and growth and survival of the pups were decreased when lactating rats were given oral doses greater than 1 mg/kg/day. A study in rats showed increased postnatal mortality at maternal oral doses of 0.2 mg/kg/day or greater, and retardation of pup growth at 15 mg/kg/day.

See references

References for pregnancy information

  1. "Product Information. Perforomist (formoterol)." Dey Laboratories, Napa, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Foradil (formoterol)" Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Foradil (formoterol)" Novartis Pharmaceuticals, East Hanover, NJ.
  4. "Product Information. Perforomist (formoterol)." Dey Laboratories, Napa, CA.

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