From the Guidelines
Sumatriptan (Imitrex) is not recommended as a first-line treatment for migraine headaches during pregnancy.
Safety Considerations
- The safety data for sumatriptan use during pregnancy are limited and primarily based on post-marketing surveillance 1.
- Due to the potential for harm to the fetus, paracetamol is recommended as the first-line medication for acute treatment of migraine in pregnancy.
- Triptans, including sumatriptan, should only be used under the strict supervision of a specialist if other treatment options are not effective 1.
- NSAIDs can be used during the second trimester, but their use should be carefully considered and monitored by a specialist.
Alternative Treatment Options
- Metoclopramide can be used to treat nausea associated with migraine in pregnancy.
- If preventive therapy is necessary, propranolol or amitriptyline can be used under specialist supervision, as they have the best available safety data 1.
- Topiramate, candesartan, and sodium valproate are contraindicated during pregnancy due to their potential to cause fetal harm 1.
From the FDA Drug Label
USE IN SPECIFIC POPULATIONS 8. 1 Pregnancy Teratogenic Effects Pregnancy Category C:There are no adequate and well-controlled trials in pregnant women. In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal Sumatriptan tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Key points:
- No adequate and well-controlled trials in pregnant women
- Developmental toxicity studies in rats and rabbits showed embryolethality, fetal abnormalities, and pup mortality
- Sumatriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
- Answer: Sumatriptan (Imitrex) is not considered safe to administer during pregnancy for migraine headaches without careful consideration of the potential risks and benefits 2.
From the Research
Safety of Sumatriptan During Pregnancy
The safety of sumatriptan (Imitrex) during pregnancy for migraine headaches has been studied in several research papers.
- The use of triptans, including sumatriptan, in pregnancy has not been extensively studied, but there are no data to suggest teratogenicity for any of the triptans 3.
- A study examining the use and effects of triptans in pregnancy found that preterm birth rates appear to be elevated, but there is no evidence of teratogenicity 3.
- The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry detected no signal of teratogenicity associated with major birth defects for sumatriptan, with an estimated risk of major birth defects following first-trimester sumatriptan exposure of 4.2% 4.
- Another study found that triptan use, including sumatriptan, was not associated with an increased risk of prematurity, low birth weight, major congenital malformations, or spontaneous abortions after adjusting for potential confounders, including maternal migraine 5.
- A review of the treatment of migraines during pregnancy noted that pregnancy registries have expanded in recent years, allowing for better determination of fetal safety for triptans, and that the information assists health care providers in selecting optimal therapy for women seeking pregnancy or those already pregnant 6.
- An evidence-based assessment of pregnancy outcome after sumatriptan exposure found no evidence for any specific effect of sumatriptan on pregnancy outcome, and that patients inadvertently exposed to sumatriptan during an early stage of pregnancy should be reassured by these data 7.
Key Findings
- No evidence of teratogenicity for sumatriptan 3, 4, 7
- Elevated preterm birth rates associated with triptan use 3
- No increased risk of prematurity, low birth weight, major congenital malformations, or spontaneous abortions associated with triptan use, including sumatriptan 5
- Pregnancy registries provide valuable information for determining fetal safety for triptans 6