Drugs in pregnancy - the dilemma of labeling
(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.
(Less)
- author
- Källén, Bengt LU
- organization
- publishing date
- 1999
- 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
- Springer
- 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
- 2022-01-30 08:06:03
@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.</p>}},
author = {{Källén, Bengt}},
issn = {{2168-4790}},
keywords = {{Congenital malformations; Drags; Labeling; Pregnancy}},
language = {{eng}},
number = {{4}},
pages = {{1135--1143}},
publisher = {{Springer}},
series = {{Therapeutic Innovation and Regulatory Science}},
title = {{Drugs in pregnancy - the dilemma of labeling}},
url = {{http://dx.doi.org/10.1177/009286159903300418}},
doi = {{10.1177/009286159903300418}},
volume = {{33}},
year = {{1999}},
}