Nancy A. Melville

November 20, 2017

SCOTTSDALE, Arizona — Triptans to treat migraine during pregnancy appear to have no major teratogenic effects, new research shows.

"Our findings support the evidence that triptans are not major teratogens. When compellingly needed during pregnancy, sumatriptan as the best studied triptan appears an acceptable treatment option," the authors, led by Christof Schaefer, MD, Charité Universitätsmedizin, Berlin, Germany, write.

The study, published online July 31 in Cephalagia,  was highlighted here at American Headache Society (AHS) 2017 Scottsdale Headache Symposium.

"There has been some mixed literature suggesting that triptans can cause low birthweight infants, spontaneous abortion and preterm labor, but at least in this study, which was a carefully conducted, prospective study, there was no evidence of that," said David W. Dodick, the former editor of Cephalagia and a professor of neurology at the Mayo Clinic in Scottsdale.

Use of antimigraine medication is common in women of childbearing age, and with up to 50% of pregnancies unplanned, unintended fetal exposure to the drugs may be common.

Meanwhile, with nonsteroidal anti-inflammatory drugs and other medications more commonly used during pregnancy, evidence on the safety of triptans has been lacking.

Most evidence on the drug class involves the drug sumatriptan, but a few smaller studies have suggested a possible link with sporadic adverse outcomes involving the drugs eletriptan and frovatriptan, including spontaneous abortion, preterm delivery, and low birthweight.

For the prospective observational study, 432 pregnant women who were enrolled in the German Embryotox system and had been exposed to triptans were compared with comparison cohorts of pregnant women without migraine disorder (n = 1733) and pregnant women with migraine disorders who were not taking triptans (n = 475).

No Major Birth Defects

After adjustment for such factors as maternal age, body mass index, smoking habits, alcohol consumption, number of previous abortions and previous parities, and number of previous children with birth defects, results showed that those treated with triptans had no significant increases in outcomes, including rates of major birth defects (odds ratio [OR], 0.84; 95% confidence interval [CI], 0.4 - 1.9), spontaneous abortions (OR, 1.20; 95% CI, 0.9 - 1.7), preterm delivery (OR, 1.01; 95% CI, 0.7 - 1.5), or preeclampsia (OR, 1.33; 95% CI, 0.7 - 2.5).

Sumatriptan was the most commonly used triptan (n = 253), followed by zolmitriptan (n = 75) and rizatriptan (n = 65).

The highest rates of birth defects were calculated for the drugs eletriptan (5.6%) and frovatriptan (5.3%), but those were based on one case of birth defects each.

Of nine major birth defects overall in the triptan-exposed cohort, two infants had been co-exposed to known teratogens, including carbamazepine and isotretinoin.

The authors note that three of the nine major birth defects were limb defects, for a prevalence of 0.8% compared with lower prevalence rates in comparison cohorts (0.5% and 0.3%); however, because of the small number of cases (n = 3), the finding may be due to chance, they write.

Most women who took triptans in pregnancy (75.2%) were exposed during the first trimester, a period in which fetuses are particularly vulnerable to drug toxicity. Very few (2.3%) had a total exposure of more than 50 days.

While the odds ratios suggest no teratogenic effects of the drugs, the authors recommend precautions with some triptans in pregnancy.

"A detailed fetal ultrasound should be offered in cases of first trimester exposure to less well-studied triptans," they note.

Good News for Women

Elizabeth W. Loder, MD, MPH, associate professor of neurology at Harvard Medical School and chief, Division of Headache and Pain in the Department of Neurology at Brigham and Women's Hospital, Boston, Massachusetts, who moderated the session, said the findings were reassuring — with some caveats.

"It is nice to see yet another study that provides information on the safety of triptans when used during pregnancy," she told Medscape Medical News.

"The point estimate for fetal malformations following pregnancy exposure was not elevated, although the confidence interval is wide and some elevation of risk cannot be completely excluded based on this study alone," she noted.

However, data from other sources are consistent with the finding, Dr Loder said.

"For example, the sumatriptan pregnancy registry that was maintained by Glaxo following the introduction of sumatriptan likewise did not show any strong signal of teratogenicity, although again the confidence interval could not completely exclude some elevation in risk," she said.

"Taken as a whole, this is good news for women who need to treat severe migraine during pregnancy."

The study authors and Dr Loder have disclosed no relevant financial relationships. Dr Dodick's disclosures include consulting for Acorda, Allergan, Amgen, Alder, Promius, eNeura, Eli Lilly & Company, Insys therapeutics, Autonomic Technologies, Teva, Xenon, Tonix, Trigemina, Nocira, Colucid, Zosano, Laydenburg Thalmann, Biocentric, Biohaven, Magellan, Charleston Laboratories. He has stock options with Nocira, Epien, Healint, Theranica, and Mobile Health and board positions with King-Devick and Epien.

American Headache Society (AHS) 2017 Scottsdale Headache Symposium. Presented November 18, 2017.

Cephalalgia. Published July 31, 2017. Abstract

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