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Sumatriptan Pregnancy and Breastfeeding Warnings

Sumatriptan is also known as: Alsuma, Imitrex, Imitrex Nasal, Imitrex Statdose, Onzetra Xsail, Sumavel DosePro, Zecuity, Zembrace SymTouch

Medically reviewed on Aug 22, 2018

Sumatriptan Pregnancy Warnings

Animal studies have revealed evidence of embryolethality, fetal abnormalities (decreased ossification, skeletal abnormalities, cervicothoracic vascular defects), decreased fetal body weight, and pup mortality. Embryolethality was most commonly reported in studies with rabbits at doses at or near those producing maternal toxicity. There are no controlled data in human pregnancy.

The first trimester use of sumatriptan in 1000 women has been reported during postmarketing surveillance. An increased risk of congenital defects was not observed; however, the data are insufficient to be conclusive. There are limited data on its use during the second and third trimesters.

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 only be given during pregnancy when benefit outweighs risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

See references

Sumatriptan Breastfeeding Warnings

Use with caution

Excreted into human milk: Yes (subcutaneous injection)

Comments:
-The effects in the nursing infant are unknown.
-Infant exposure can be minimized by avoiding breastfeeding for at least 8 to 12 hours after treatment with this drug.

Sumatriptan has poor oral bioavailability, decreasing infant exposure to the drug. Because of the low levels of sumatriptan in breastmilk, amounts ingested by the infant are small. Sumatriptan would not be expected to cause any adverse effects in most breastfed infants.

Peak milk level of sumatriptan averaged 87.2 mcg/L and occurred 2.5 hours after a single subcutaneous dose in 5 women who had been breastfeeding for 11 to 28 weeks. The mean half-life in milk was reported as 2.2 hours.

See references

References for pregnancy information

  1. "Product Information. Imitrex injection (sumatriptan)." Cerenex Pharmaceuticals, Research Triangle Pk, NC.
  2. "Product Information. Imitrex (sumatriptan)." Glaxo Wellcome, Research Triangle Park, NC.
  3. "Product Information. Alsuma (SUMAtriptan)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Hilaire ML, Cross LB, Eichner SF "Treatment of migraine headaches with sumatriptan in pregnancy." Ann Pharmacother 38 (2004): 1726-30
  6. "Product Information. Imitrex nasal spray (sumatriptan)." Glaxo Wellcome, Research Triangle Park, NC.

References for breastfeeding information

  1. "Product Information. Imitrex (sumatriptan)." Glaxo Wellcome, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Alsuma (SUMAtriptan)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  4. "Product Information. Imitrex nasal spray (sumatriptan)." Glaxo Wellcome, Research Triangle Park, NC.
  5. "Product Information. Zecuity (SUMAtriptan)." Teva Pharmaceuticals USA, North Wales, PA.
  6. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  7. "Product Information. Imitrex injection (sumatriptan)." Cerenex Pharmaceuticals, Research Triangle Pk, NC.
  8. "Product Information. Onzetra Xsail (SUMAtriptan)." Avanir Pharmaceuticals, Inc, Aliso Viejo, CA.
  9. Cerner Multum, Inc. "Australian Product Information." O 0
  10. "Product Information. SUMAtriptan Succinate (SUMAtriptan)." Bedford Laboratories, Bedford, OH.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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