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Abstract Details

Dihydroergotamine: A Review of Maternal Exposure during Pregnancy
Headache
P03 - (-)
108
BACKGROUND: Pregnancy risk categories are assigned to US drugs based on evidence from animal and human studies. Current formulations of DHE and ergotamine have the same pregnancy risk category (X), although DHE has fewer vascular and uterine effects.
DESIGN/METHODS: A MEDLINE/PubMed search was conducted to identify citations published from January 1945 to October 2011 and describing fetal outcomes associated with DHE or ergotamine use during pregnancy. Included were clinical research, case reports/series, database/retrospective reviews or studies, and articles identified through secondary searches of related articles and references that include primary authors. Study designs, treatment interventions, and outcomes were reviewed.
RESULTS: Of 213 potential citations, 11 met criteria for inclusion. Fetal outcome data for >350 infants with DHE exposure in utero did not show a statistically significant increased risk of major congenital malformations. An increased risk of prematurity, however, has been reported. Transient fetal bradycardia was also reported when DHE was used during labor. Increased miscarriage risk was possibly associated with high intravenous doses administered to induce labor.
CONCLUSIONS: In this literature analysis, DHE use during pregnancy was not reported to be associated with a statistically significant risk of major congenital malformations. It was however associated with a higher risk of prematurity.
Authors/Disclosures
Stephen D. Silberstein, MD, FAAN
PRESENTER 		Dr. Silberstein has received publishing royalties from a publication relating to health care.
Shashidhar Kori, MD Dr. Kori has received personal compensation for serving as an employee of Novilla Pharma. Dr. Kori has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Satsuma Pharma. Dr. Kori has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Tonix Pharma. Dr. Kori has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Exalys Pharma. Dr. Kori has received personal compensation in the range of $0-$499 for serving as a Consultant for NewBio Pharma. Dr. Kori has received personal compensation in the range of $0-$499 for serving as a Consultant for Afsci Pharma. Dr. Kori has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Trigemina Inc. Dr. Kori has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Novilla Pharma. Dr. Kori has received stock or an ownership interest from Novilla Pharma. Dr. Kori has received stock or an ownership interest from NewBio Pharma. Dr. Kori has received stock or an ownership interest from Tonix Pharma. Dr. Kori has received intellectual property interests from a discovery or technology relating to health care. Dr. Kori has received intellectual property interests from a discovery or technology relating to health care. Dr. Kori has received personal compensation in the range of $0-$499 for serving as a Reviewer of grant applications with Department of Defense.
Dawn C. Buse, PhD (Dawn C. Buse, PhD) Dr. Buse has received personal compensation for serving as an employee of Vector Psychometric Group. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranicsa. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Buse has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Reports. The institution of Dr. Buse has received research support from Amgen. The institution of Dr. Buse has received research support from FDA. The institution of Dr. Buse has received research support from National Headache Foundation.
Helena C. Chui, MD (University of Southern California) The institution of Dr. Chui has received research support from National Institute on Aging .
Dawn Marcus, MD No disclosure on file
Walter N. Korz No disclosure on file
Sheena K. Aurora, MD (Department of Neurology and Neurological Sciences) Dr. Aurora has received personal compensation for serving as an employee of Alzheimer's Association.
Gretchen E. Tietjen, MD An immediate family member of Dr. Tietjen has stock in Johnson & Johnson.
No disclosure on file
No disclosure on file
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine) Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.