Exposure to Rizatriptan During Pregnancy: Post-Marketing Experience up to 30 June 2004

Abstract

Merck & Co., Inc. evaluates outcomes of the use of rizatriptan during pregnancy through a Pregnancy Registry in the United States (US) and spontaneous reports for pregnancies reported from sources outside the US. Review of the outcomes of 25 prospective pregnancy reports in the Pregnancy Registry and reports from other sources does not suggest that treatment with rizatriptan predisposes patients to spontaneous abortions or congenital anomalies. However, the number of reports is small. Healthcare providers in the United States are encouraged to report any prenatal exposure to rizatriptan by calling the Pregnancy Registry at +1 (800) 986 8999 or visiting the Registry's website at http://www.merckpregnancyregistries.com.

A review of the 5-HT1B/1D agonist rizatriptan: update on recent research and implications for the future

“…Although in preclinical studies rizatriptan did not induce developmental effects, it has not been formally tested in pregnant women. International post-marketing surveillance data regarding rizatriptan exposure in pregnant women were recently summarized by Fiore et al for the time period between approval of rizatriptan (1998) and 30 June 2004 [55] . The summary was based on reports of pregnancy temporally associated with rizatriptan exposure as received by the sponsor from clinicians and does not suggest that rizatriptan increased the risk of congenital birth defects.…”

“…The summary was based on reports of pregnancy temporally associated with rizatriptan exposure as received by the sponsor from clinicians and does not suggest that rizatriptan increased the risk of congenital birth defects. Nevertheless, the sample size was insufficient to allow meaningful conclusions and, therefore, the current label precautions for rizatriptan remain unchanged (pregnancy category C, for use in pregnant women only when potential maternal benefit justifies potential fetal risk) [55] .…”

Analgesics and anti-inflammatory drugs

“…There are almost 100 prospective and retrospective case reports on rizatriptan collected by the Swedish medical birth registry and the producer, and these do not indicate teratogenicity (Fiore 2005).…”

Neues zu Kopfschmerzen 2010

“…Dies galt auch, wenn Triptane während der üb-rigen Schwangerschaft verwendet wurden. Diese Ergebnisse stimmen mit den Ergebnissen anderer prospektiver Datenbanken überein [32][33][34][35] …”