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Drugs in pregnancy - the dilemma of labeling

Källén, Bengt LU (1999) In Therapeutic Innovation and Regulatory Science 33(4). p.1135-1143
Abstract

The paper discusses the problems with pregnancy labeling of drugs. The Swedish, United States, and Australian labeling systems are briefly summarized. Data on drug use in early pregnancy in Sweden (1996) are presented according to pregnancy labeling category and with details on drugs thought to be teratogenic or where animal data suggest hazards. The various situations when drug teratogenicity are of interest are reviewed and the difficulties in presenting detailed pregnancy warnings valid for all situations are stressed. The amount of data needed for information in the different situations is discussed and exemplified. Finally, suggestions are made on how texts referring to drug use during pregnancy can be structured for different drug... (More)

The paper discusses the problems with pregnancy labeling of drugs. The Swedish, United States, and Australian labeling systems are briefly summarized. Data on drug use in early pregnancy in Sweden (1996) are presented according to pregnancy labeling category and with details on drugs thought to be teratogenic or where animal data suggest hazards. The various situations when drug teratogenicity are of interest are reviewed and the difficulties in presenting detailed pregnancy warnings valid for all situations are stressed. The amount of data needed for information in the different situations is discussed and exemplified. Finally, suggestions are made on how texts referring to drug use during pregnancy can be structured for different drug categories. © 1999, Drug Information Association. All rights reserved.

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Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Congenital malformations, Drags, Labeling, Pregnancy
in
Therapeutic Innovation and Regulatory Science
volume
33
issue
4
pages
9 pages
publisher
Pergamon
external identifiers
  • scopus:84996262920
ISSN
2168-4790
DOI
10.1177/009286159903300418
language
English
LU publication?
yes
id
303cc73d-11e0-4a4e-a598-a0627095c309
date added to LUP
2016-12-05 11:47:32
date last changed
2017-02-22 10:46:56
@article{303cc73d-11e0-4a4e-a598-a0627095c309,
  abstract     = {<p>The paper discusses the problems with pregnancy labeling of drugs. The Swedish, United States, and Australian labeling systems are briefly summarized. Data on drug use in early pregnancy in Sweden (1996) are presented according to pregnancy labeling category and with details on drugs thought to be teratogenic or where animal data suggest hazards. The various situations when drug teratogenicity are of interest are reviewed and the difficulties in presenting detailed pregnancy warnings valid for all situations are stressed. The amount of data needed for information in the different situations is discussed and exemplified. Finally, suggestions are made on how texts referring to drug use during pregnancy can be structured for different drug categories. © 1999, Drug Information Association. All rights reserved.</p>},
  author       = {Källén, Bengt},
  issn         = {2168-4790},
  keyword      = {Congenital malformations,Drags,Labeling,Pregnancy},
  language     = {eng},
  number       = {4},
  pages        = {1135--1143},
  publisher    = {Pergamon},
  series       = {Therapeutic Innovation and Regulatory Science},
  title        = {Drugs in pregnancy - the dilemma of labeling},
  url          = {http://dx.doi.org/10.1177/009286159903300418},
  volume       = {33},
  year         = {1999},
}