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Result Summary for EPI40050

Result Summary

Protocol ID:	EPI40050
Clinical Study ID:	EPI40050
Official Title:	The Sumatriptan and Naratriptan Pregnancy Registry
Phase:	Phase 4
Study Indications or Diseases:	Migraine Disorders
Generic Name:	naratriptan
Trade/Product Name:	amerge;naramig
Approved Drug Label:	http://www.gsk.com/products.html
Results Summary:	Click here to download result summary.
Citations:	Centers for Disease Control and Prevention: Metropolitan Atlanta Congenital Defects Program Procedure Manual. July 1989 (Revised January 1998); A1-B11. To access a copy of the MACDP defect code, please go to http://www.cdc.gov/ncbddd/bd/macdp_resources.htm and click on the link to the .pdf file. Botto LD, Correa A, Erickson JD. Racial and temporal variations in the prevalence of heart defects. Pediatrics 2001;107:E32. Correa A, Cragan JD, Kucik JE, et al. Metropolitan Atlanta Congenital Defects Program 40th Anniversary Edition Surveillance Report: Reporting Birth Defects Surveillance Data 1968-2003. Birth Defects Research (Part A) 2007; 79 (2):65-186. Kallen B, Lygner PE. Delivery outcome in women who used drugs for migraine during pregnancy with special reference to Sumatriptan. Headache 2001;41:351-356. Reiff-Eldridge RR, Heffner CR, Ephross SA, Tennis PS, White AD, Andrews EB. Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment. Am J Obstet Gynaecol. 2000; 182 (1 Pt 1): 159-63. Sumatriptan and Naratriptan Pregnancy Registry. Interim Report 1 January 1996 through 31 October 2006. Issued February 2007. Available at: http://pregnancyregistry.gsk.com/index.html Correa-Villaseñor A, Cragan J, Kucik J, O’Leary L, Siffel C, Williams L. The Metropolitan Atlanta Congenital Defects Program: 35 Years of Birth Defects Surveillance at the Centers for Disease Control and Prevention. Birth Defects Research (Part A) 2003; 67:617-624. Eldridge RR, Ephross SA. Monitoring birth outcomes in the sumatriptan pregnancy registry. Prim Care Update Ob Gyns. 1998; 5(4): 190. Roguin N, Du ZD, Barak M, Nasser N, Hershkowitz S, Milgram E. High prevalence of muscular ventricular septal defect in neonates. J Am Coll Cardiol 1995;26:1545-1548. Eldridge RR, Ephross SA, Heffner CR, Tennis PS, Stender DM, White AD. Monitoring pregnancy outcomes following prenatal drug exposure through prospective pregnancy registries and passive surveillance: a pharmaceutical company commitment. Prim Care Update Ob Gyns. 1998; 5(4): 90-191.