COLLECTION AND ANALYSIS OF DRUG SAFETY DATA IN PREGNANCY

Main Article Content

Myla Moretti

Keywords

DRUG SAFETY DATA

Abstract

Much of what I will touch on will be taken from the perspective of Motherisk, where we as service providers speak to patients and practitioners on a day to day basis. Why do we want to collect and analyze drug safety data in pregnancy? The most important reason is to discover possible adverse pregnancy outcomes associated with drugs and other exposures during pregnancy. We also want to be able to identify signals and establish risks early in the life span of a drug release; and finally, to disseminate this information back to patients and health care providers so that rational choices about disease management in pregnancy can be made. We therefore need to collect the information, analyze it, and report it back in a way that is scientifically valid but also makes sense to the clinician and patient who needs the information.

Abstract 128 | PDF Downloads 69

References

1. Moretti M, Koren G. Motherisk: The Toronto Model for Counseling in Reproductive Toxicology. 2004: 767-789.
2. Bonati M, Bortolus R, Marchetti F, Romero M, Tognoni G. Drug use in pregnancy: an overview of epidemiological (drug utilization) studies. Eur J Clin Pharmacol 1990;38:325-328.
3. Reiff-Eldridge R, Heffner CR, Ephross SA, Tennis PS, White AD, Andrews EB. Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment. Am J Obstet Gynecol 2000;182:159-163.
4. US Food and Drug Administration. Guidance for industry establishing pregnancy exposure registries. Rockville (MD): US Department of Health and Human Services; 2002.
5. Rosa F. Databases in the assessment of the effects of drugs during pregnancy. J Allergy Clin Immunol 1999;103:S360-S361.
6. Axelsson O. The Swedish medical birth register. Acta Obstet Gynecol Scand 2003;82:491-492.
7. Moretti ME, Caprara D, Coutinho CJ et al . Fetal safety of loratadine use in the first trimester of pregnancy: a multicenter study. J Allergy Clin Immunol 2003;111:479-483.