Drugs in pregnancy - the dilemma of labeling

Bengt Källén

Research output: Contribution to journalArticlepeer-review

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 categories.

Original languageEnglish
Pages (from-to)1135-1143
Number of pages9
JournalTherapeutic Innovation and Regulatory Science
Volume33
Issue number4
DOIs
Publication statusPublished - 1999

Subject classification (UKÄ)

  • Pharmacology and Toxicology
  • Health Care Service and Management, Health Policy and Services and Health Economy

Free keywords

  • Congenital malformations
  • Drags
  • Labeling
  • Pregnancy

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