Soon we'll have more data on prescription drug safety during pregnancy. To get around the obvious problem with safety trials in pregnant women--who'd volunteer?-- the FDA is funding a retrospective analysis of data gathered on about 1 million births between 2001 and 2007, the agency says.
Researchers from Vanderbilt University, Kaiser Permanente and HMO Research Network Center for Education and Research in Therapeutics will examine information on pregnant women, the prescription drugs they used, and the children they delivered to see whether drugs are linked to any adverse outcomes.
About two-thirds of women who deliver have used at least one prescription during pregnancy, the agency says in a statement. "Results of these studies will provide valuable information for patients and physicians when making decisions about medications during pregnancy," one of the researchers says. FDA Commish Margaret Hamburg adds the new data also will guide regulatory policy.
- read the FDA statement [1]
- see the piece [2] from the Wall Street Journal Health Blog
Related Articles:
Abbott drug safety in FDA spotlight [3]
Jury: Glaxo's Paxil caused birth defects [4]
Links:
[1] http://www.fiercebiotech.com/press-releases/fda-health-organizations-study-safety-medications-taken-during-pregnancy-0
[2] http://blogs.wsj.com/health/2009/12/31/which-drugs-are-safe-to-take-during-pregnancy/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+wsj%2Fhealth%2Ffeed+%28WSJ.com%3A+Health+Blog%29&mod=smallbusiness
[3] http://www.fiercepharma.com/story/abbott-drug-safety-fda-spotlight/2009-12-04
[4] http://www.fiercepharma.com/story/jury-glaxos-paxil-caused-birth-defects/2009-10-14