Skip to Content

Sumatriptan Pregnancy and Breastfeeding Warnings

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

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. Hilaire ML, Cross LB, Eichner SF "Treatment of migraine headaches with sumatriptan in pregnancy." Ann Pharmacother 38 (2004): 1726-30

References for breastfeeding information

  1. "Product Information. Imitrex (sumatriptan)." Glaxo Wellcome, Research Triangle Park, NC.
  2. "Product Information. Alsuma (SUMAtriptan)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Imitrex nasal spray (sumatriptan)." Glaxo Wellcome, Research Triangle Park, NC.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.