From the Guidelines
Sumatriptan should be used with caution during pregnancy, only under the strict supervision of a specialist, due to limited safety data available, as stated in the 2021 study published in Nature Reviews Neurology 1. When considering the use of sumatriptan during pregnancy, it is essential to weigh the potential benefits against the potential risks to the fetus.
- The safety data available for sumatriptan are limited and originate from post-marketing surveillance, with most data relating to its use 1.
- Paracetamol is recommended as the first-line medication for acute treatment of migraine in pregnancy, while NSAIDs can be used only during the second trimester 1.
- If sumatriptan is used, it should be under strict supervision, and the lowest effective dose for the shortest duration should be considered, ideally after the first trimester if possible.
- Women who are pregnant or planning pregnancy should discuss migraine management with their healthcare provider to develop a personalized treatment plan that balances symptom relief with minimizing potential risks to the developing fetus.
- Non-pharmacological approaches such as rest in a dark, quiet room, cold compresses, and relaxation techniques should be tried first before considering medication.
- Any woman who has taken sumatriptan while pregnant should inform her obstetrician to ensure appropriate monitoring, as preventive migraine medications are best avoided during pregnancy owing to the potential for 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 tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
- Answer: Sumatriptan is not considered safe during pregnancy, and its use should be justified by the potential benefit outweighing the potential risk to the fetus 2.
From the Research
Safety of Sumatriptan During Pregnancy
- The safety of sumatriptan during pregnancy has been evaluated in several studies, with varying conclusions 3, 4, 5, 6, 7.
- A 1998 study found that triptans, including sumatriptan, are contraindicated in women who are pregnant, due to the potential risks associated with their use 3.
- However, a 2002 study found no evidence of any specific effect of sumatriptan on pregnancy outcome, and suggested that patients inadvertently exposed to sumatriptan during an early stage of pregnancy should be reassured by these data 4.
- A 2008 review of available data on the use of serotonin 5-HT(1) agonists during pregnancy found that sumatriptan appears to be a safe treatment alternative for pregnant women who experience new-onset or worsened migraines in the first trimester, but further observation is needed prior to recommending its use in later trimesters 5.
- A 2003 review of the medical literature found that current information is not sufficient to rule out small increases in the risk for birth defects associated with sumatriptan use during pregnancy, and therefore caution should be exercised in making a positive recommendation for its use 6.
- A 1999 prospective study found no differences in pregnancy outcome between women who used sumatriptan after conception and those who did not, but the sample size was limited 7.
Key Findings
- Sumatriptan is currently labeled as pregnancy category C, meaning that it is not recommended for use during pregnancy unless the potential benefit justifies the potential risk to the fetus 4.
- The available data suggest that sumatriptan may be safe for use during the first trimester of pregnancy, but more research is needed to fully understand its effects 5, 6, 7.
- Women who are pregnant or planning to become pregnant should discuss the potential risks and benefits of sumatriptan use with their healthcare provider 3, 4, 5, 6, 7.