The Safety of Sumatriptan and Naratriptan in Pregnancy: What Have We Learned?
Marianne Cunnington, PhD; Sara Ephross, PhD; Paige Churchill, BA

Posted: 02/08/2010; Headache. 2009;49(10):1414-1422. © 2009


CONCLUSIONS.—The risk of all major birth defects following first-trimester exposure to sumatriptan was 4.6% (95% CI 2.9–7.2%). This coupled with a consistent failure of additional epidemiological studies to observe a signal for major teratogenicity gives a level of reassurance concerning the safety of sumatriptan in pregnancy. There are too few data on naratriptan to draw definitive conclusions, and the sample size for sumatriptan remains too small to detect any but very large increases in specific birth defects.
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Ann Pharmacother. 2004 Oct;38(10):1726-30. Epub 2004 Aug 17.   


Treatment of migraine headaches with sumatriptan in pregnancy.

Hilaire ML, Cross LB, Eichner SF.

University of Tennessee Family Practice Center, Memphis, TN, USA. mhilaire@utmem.edu

OBJECTIVE: To review the literature for treatment of migraine headaches with sumatriptan during pregnancy. DATA SOURCES: Studies and reports were located in International Pharmaceutical Abstracts (1970-September 2003) and MEDLINE (1966-week 3 September 2003). DATA SYNTHESIS: Research has been performed to evaluate the risk of teratogenesis after sumatriptan exposure in pregnant patients. Data have been collected in areas including placental transmission of sumatriptan, prospective pregnancy registries, open-labeled and controlled prospective studies, and a retrospective prescription-linked study. As of August 6, 2004, no randomized controlled trials have been conducted with exposure to sumatriptan during pregnancy. CONCLUSIONS: Teratogenesis occurs in approximately 150 000 births per year which represents an incidence of 3-5%. Available literature to date indicates that exposure to sumatriptan during pregnancy has no additional risk of birth defects compared with the incidence in the general population.

Publication Types:
Review

PMID: 15316107 
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CNS Drugs. 2003;17(1):1-7.   


Safety of sumatriptan in pregnancy: a review of the data so far.

Loder E.

Harvard Medical School, Boston, Massachusetts, USA. eloder@partners.org

The high prevalence of migraine in women during their reproductive years means that new drug treatments for migraine, such as the serotonin 5-HT(1B/1D) receptor agonists (the 'triptans'), are likely to be widely used by women of childbearing potential. Scrutiny of these agents in an effort to detect any signal of teratogenicity is thus important. A systematic review of the medical literature was conducted to identify information regarding the safety of sumatriptan during pregnancy. This agent was chosen to be investigated because it has been available for the longest and is the most widely used of the triptan class. Information was obtained regarding the impact of migraine on pregnancy outcome, and data on sumatriptan use in pregnancy were obtained from animal studies, preclinical drug trials, postmarketing surveillance efforts, prospective pregnancy registries, national birth registries and teratogen information services. Synthesis of information from these sources is sufficient to rule out a large increase in birth defects from sumatriptan use during pregnancy and is reassuring for cases where inadvertent exposure to sumatriptan during pregnancy has occurred. However, current information is not sufficient to rule out small increases in the risk for birth defects. For this reason, caution should be exercised in making a positive recommendation for the use of sumatriptan during pregnancy.

Publication Types:
Review
Review, Tutorial

PMID: 12467489