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Use of tramadol in early pregnancy and congenital malformation risk.

Author

  • Bengt Källén
  • Margareta Reis

Summary, in English

Only few studies exist regarding the risk of a teratogenic effect of tramadol when used in early pregnancy. Using the Swedish Medical Birth Register, women (deliveries in 1997-2013) who had reported the use of tramadol in early pregnancy were identified. Maternal characteristics and concomitant drug use were analyzed. Among 1 682 846 women (1 797 678 infants), 1751 (1776 infants) had used tramadol, 96 of the infants had a congenital malformation and 70 of them were relatively severe. The adjusted odds ratio for a relatively severe malformation was 1.33 (95% CI 1.05-1.70). The odds ratios for cardiovascular defects (1.56, 95% CI 1.04-2.29) and for pes equinovarus (3.63, 95% CI 1.61-6.89) were significantly increased. The study suggests a teratogenic effect of tramadol but the risk increase is moderate.

Publishing year

2015

Language

English

Pages

246-251

Publication/Series

Reproductive Toxicology

Volume

58

Issue

oct 16

Document type

Journal article

Publisher

Elsevier

Topic

  • Gynaecology, Obstetrics and Reproductive Medicine

Status

Published

Research group

  • Tornblad Institute

ISBN/ISSN/Other

  • ISSN: 1873-1708