Obstetrics & Gynecology Email Alerts
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Obstetrics & Gynecology 2002;100:465-473
© 2002 by The American College of Obstetricians and Gynecologists
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Lo, W. Y.
Right arrow Articles by Friedman, J. M.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Lo, W. Y.
Right arrow Articles by Friedman, J. M.

ORIGINAL RESEARCH

Teratogenicity of Recently Introduced Medications in Human Pregnancy

W. Y. Lo, BSc and J. M. Friedman, MD, PhD

From the Department of Medical Genetics, University of British Columbia, Vancouver, British Columbia, Canada.

Address reprint requests to: J. M. Friedman, MD, PhD, University of British Columbia, Department of Medical Genetics, 6174 University Boulevard, Vancouver, British Columbia V6T 1Z3, Canada; E-mail: frid{at}interchange.ubc.ca.

OBJECTIVE: To determine how long it takes after a new drug is marketed to establish whether or not its use by pregnant women is likely to pose a substantial teratogenic risk.

METHODS: We used standard clinical teratology resources to assess the teratogenic risks in human pregnancy of therapeutic treatment with 468 drugs approved by the US Food and Drug Administration between 1980 and 2000. The teratogenic risk of each treatment was classified using the current online version of TERIS into one of three categories: 1) no risk, minimal risk, or unlikely to produce an increased risk; 2) associated with a small, moderate, or high risk; or 3) risk undetermined.

RESULTS: We found that the teratogenic risk in human pregnancy was still undetermined for 91.2% of drug treatments approved in the United States between 1980 and 2000. The proportion of treatments classified as having an "undetermined" teratogenic risk was more than 80% for drugs approved for marketing 0–4, 5–9, 10–14, or 15–20 years ago, but the highest proportion of drugs with an "undetermined" teratogenic risk was found among those approved 15–20 years ago. The agreement between TERIS risk ratings and Food and Drug Administration Use-in-Pregnancy Categories for 163 drugs that had been assessed by both systems was poor ({kappa} ± standard error = 0.082 ± 0.042).

CONCLUSION: We conclude that inadequate information is available for pregnant women and their physicians to determine whether the benefits exceed the teratogenic risks for most drug treatments introduced in the past 20 years.




This article has been cited by other articles:


Home page
 NeurologyHome page
L. B. Holmes, E. J. Baldwin, C. R. Smith, E. Habecker, L. Glassman, S. L. Wong, and D. F. Wyszynski
Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy
Neurology, May 27, 2008; 70(22_Part_2): 2152 - 2158.
[Abstract] [Full Text] [PDF]

Home page
 J. Am. Med. Inform. Assoc.Home page
M. A. Raebel, N. M. Carroll, J. A. Kelleher, E. A. Chester, S. Berga, and D. J. Magid
Randomized Trial to Improve Prescribing Safety During Pregnancy
J. Am. Med. Inform. Assoc., July 1, 2007; 14(4): 440 - 450.
[Abstract] [Full Text] [PDF]

Home page
 NEJMHome page
J.M. Friedman
ACE inhibitors and congenital anomalies.
N. Engl. J. Med., June 8, 2006; 354(23): 2498 - 2500.
[Full Text] [PDF]

Home page
 Diabetes CareHome page
Z. T. Bloomgarden
Aspects of type 2 diabetes and related insulin-resistant States.
Diabetes Care, March 1, 2006; 29(3): 732 - 740.
[Full Text] [PDF]

Home page
 Am. J. Public HealthHome page
S. A. Rasmussen and E. B. Hayes
Public Health Approach to Emerging Infections Among Pregnant Women
Am J Public Health, November 1, 2005; 95(11): 1942 - 1944.
[Abstract] [Full Text] [PDF]

Home page
 Obstet GynecolHome page
D. L. Covington, S. D. Conner, P. A. Doi, J. Swinson, and E. M. Daniels
Risk of Birth Defects Associated With Nelfinavir Exposure During Pregnancy
Obstet. Gynecol., June 1, 2004; 103(6): 1181 - 1189.
[Abstract] [Full Text] [PDF]

Home page
 Arch NeurolHome page
L. B. Holmes, D. F. Wyszynski, and E. Lieberman
The AED (Antiepileptic Drug) Pregnancy Registry: A 6-Year Experience
Arch Neurol, May 1, 2004; 61(5): 673 - 678.
[Abstract] [Full Text] [PDF]

Home page
 PediatricsHome page
S. M. Mone, M. W. Gillman, T. L. Miller, E. H. Herman, and S. E. Lipshultz
Effects of Environmental Exposures on the Cardiovascular System: Prenatal Period Through Adolescence
Pediatrics, April 1, 2004; 113(4/S1): 1058 - 1069.
[Abstract] [Full Text] [PDF]

Home page
 J. Med. EthicsHome page
M Spriggs and T Charles
Should HIV discordant couples have access to assisted reproductive technologies?
J. Med. Ethics, December 1, 2003; 29(6): 325 - 329.
[Abstract] [Full Text] [PDF]

Home page
 AAP NewsHome page
C. Kemp
Teratogenicity of drugs often unknown
AAP News, December 1, 2002; 21(6): 272 - 272.
[Full Text] [PDF]

Home page
 JWatch GeneralHome page
What Do We Know About the Teratogenicity of Drugs?
Journal Watch (General), September 20, 2002; 2002(920): 6 - 6.
[Full Text]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 2002 by the American College of Obstetricians and Gynecologists.