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DOI: 10.1055/s-0031-1297974
Do Drug Warnings and Market Withdrawals Have an Impact on the Number of Calls to Teratogen Information Services?
Publikationsverlauf
received 24. August 2011
revised 11. November 2011
accepted 16. November 2011
Publikationsdatum:
30. Januar 2012 (online)
Abstract
Background:
IMAGe provides information on risks and benefits of medication use during pregnancy and lactation
Objective:
The aim of this study was to determine the impact of Health Canada warnings on the number of calls received at IMAGe.
Methods:
We analyzed calls received between January 2003 and March 2008. The impact of the following warning/withdrawal were studied: paroxetine and risk of cardiac malformations (09/29/2005), selective serotonin reuptake inhibitors (SSRIs) and risk of persistent pulmonary hypertension of the newborn (PPHN) (03/10/2006), and impact of rofecoxib market withdrawal (09/30/2004). Interrupted auto-regressive integrated moving average (ARIMA) analyses were used to test the impact of each warning on the number of calls received to IMAGe.
Results:
61 505 calls were analyzed. The paroxetine warning had a temporary impact increasing the overall number of calls to IMAGe, and an abrupt permanent effect on the number of calls related to antidepressant exposures. The PPHN warning had no impact but we observed a significant increase in the number of calls following rofecoxib market withdrawal.
Conclusion:
Health Canada needs to consider the increase in the demand of information to IMAGe following warnings on the risk of medication use during pregnancy.
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References
- 1 Andrade SE, Gurwitz JH, Davis RL et al. Prescription drug use in pregnancy. Am J Obstet Gynecol 2004; 191: 398-407
- 2 Headley J, Northstone K, Simmons H et al. Medication use during pregnancy: data from the Avon longitudinal study of parents and children. Eur J Clin Pharmacol 2004; 60: 355-361
- 3 Matheson I, Kristensen K, Lunde PK. Drug utilization in breast-feeding women. A survey in Oslo Eur J Clin Pharmacol 1990; 38: 453-459
- 4 Schirm E, Schwagermann MP, Tobi H et al. Drug use during breastfeeding. A survey from the Netherlands. Eur J Clin Nutr 2004; 58: 386-390
- 5 Breart G. Delayed childbearing. Eur J Obstet Gynecol Reprod Biol 1997; 75: 71-73
- 6 Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect 1998; 30: 24-29 46
- 7 Zajicek A, Giacoia GP. Obstetric clinical pharmacology: coming of age. Clin Pharmacol Ther 2007; 81: 481-482
- 8 Mattison D, Zajicek A. Gaps in knowledge in treating pregnant women. Gend Med 2006; 3: 169-182
- 9 Einarson A, Park A, Koren G. How physicians perceive and utilize information from a teratogen information service: the Motherisk Program. BMC Med Educ 2004; 4: 6
- 10 Hancock RL, Koren G, Einarson A et al. The effectiveness of Teratology Information Services (TIS). Reprod Toxicol 2007; 23: 125-132
- 11 Gendron MP, Martin B, Oraichi D et al. Health care providers’ requests to Teratogen Information Services on medication use during pregnancy and lactation. Eur J Clin Pharmacol 2009; 65: 523-531
- 12 Sanz E, Gomez-Lopez T, Martinez-Quintas MJ. Perception of teratogenic risk of common medicines. Eur J Obstet Gynecol Reprod Biol 2001; 95: 127-131
- 13 MSSO. MedDRA terminology. http://www.meddramsso.com 2008 (last accessed December 18 2008)
- 14 GlaxoSmithKline. New safety information regarding paroxetine: Findings suggest increased risk over antidepressants, of congenital malformations, following first trimester exposure to paroxetine. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/medeff/paxil_3_hpc-cps-eng.pdf 2005 (last accessed November 05 2008)
- 15 Health Canada, Advisory. Newer antidepressants linked to serious lung disorder in newborns. www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2006/2006_11-eng.php 2006 (last accessed February 12 2009)
- 16 Health Canada. Merck Sharp & Dohme (MSD) Annouces Voluntary Worldwide Withdrawal of VIOXX (rofecoxib). www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2004/vioxx_2_hpc-cps-eng.php 2004 (last accessed November 28 2008)
- 17 Gillings D, Makuc D, Siegel E. Analysis of interrupted time series mortality trends: an example to evaluate regionalized perinatal care. Am J Public Health 1981; 71: 38-46
- 18 Wagner AK, Soumerai SB, Zhang F et al. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther 2002; 27: 299-309
- 19 Box GEP, Jenkins G. Time Series Analysis: Forecasting and Control. San Francisco: 1976
- 20 Héon D. Qu’est-ce qui génère les avis de Santé Canada concernant les femmes enceintes?. 2e Symposium Medications and Pregancy. April 17th. 2008
- 21 Kurdyak PA, Juurlink DN, Mamdani MM. The effect of antidepressant warnings on prescribing trends in Ontario, Canada. Am J Public Health 2007; 97: 750-754
- 22 Einarson A, Schachtschneider AK, Halil R et al. SSRI’S and other antidepressant use during pregnancy and potential neonatal adverse effects: impact of a public health advisory and subsequent reports in the news media. BMC Pregnancy Childbirt 2005; 5: 11
- 23 Health Canada. Health Canada Drug Product Database (DPD). http://webprod.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp 2008 (last accessed December 07 2008)
- 24 World Health Organization (WHO). Anatomical Therapeutic Chemical (ATC). http://www.whocc.no/atcddd/atcsystem.html 2008 (last accessed December 20 2008)