Navigation Links
FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy
Date:12/30/2009

New collaborative research program to study effects on mothers and their babies

SILVER SPRING, Md., Dec. 30 /PRNewswire-USNewswire/ -- A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente's multiple research centers and Vanderbilt University.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child.

"This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children," said Margaret Hamburg, MD, Commissioner of Food and Drugs. "These data will guide regulatory policy and influence medical practice."

To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research program will link health care information for mothers and their babies in each of the participating research sites. Collectively, the 11 participating sites have health care information for about 1 million births over the past seven years (2001-2007). Many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network.

"This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children," said Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA's Center for Drug Evaluation and Research. "Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy."

The program blends clinical and research expertise and population-based databases from 11 health plan-affiliated research sites including Kaiser Permanente (Northern California, Southern California, Georgia,, Pacific Northwest, and Colorado regions); Harvard Pilgrim Health Care Institute, Group Health Research Institute, HealthPartners, Lovelace Clinic Foundation, the Meyers Primary Care Institute, and Tennessee State Medicaid, and the FDA. The HMO Research Network CERT Data Center at the Department of Population Medicine of Harvard Medical School and Harvard Pilgrim Health Care Institute, led by Richard Platt, M.D., M.S., is the coordinating center for the program.

Lead researchers include Susan Andrade, Sc.D. HMO Research Network William Cooper, M.D., M.P.H. (Vanderbilt); Robert Davis, M.D., M.P.H. (Kaiser Permanente Georgia); Craig Cheetham, Pharm.D.; (Kaiser Permanente Southern California); and De-Kun Li, M.D., Ph.D. (Kaiser Permanente Northern California). The investigators have collaborated on numerous studies related to medication use during pregnancy and birth outcomes, as well as studies on the effects of anti-depressant medications, antibiotics, and cardiovascular medications on birth defects and perinatal outcomes.

A Steering Committee composed of representatives from each participating site and the FDA will oversee MEPREP activities and provide overall scientific leadership. FDA epidemiologist, Pamela E. Scott, Ph.D., is the FDA project lead and chair of the Steering Committee.

Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov, Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Inverness Medical Innovations to Present at the J.P. Morgan Healthcare Conference on January 12, 2010
2. Endo to Present at J.P. Morgan 28th Annual Healthcare Conference
3. BD to Present at Investor Healthcare Conferences
4. IQAir HealthPro Plus Selected as a Top 10 Product for Parents
5. Masimo to Present at the 28th Annual J.P. Morgan Healthcare Conference
6. Hospira to Present at J.P. Morgan 28th Annual Healthcare Conference Jan. 13, 2010
7. University of Mississippi Health Care Implements Philips VISICU eICU(R) Program
8. Sigma-Aldrich to Present at the 28th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2010
9. Intermountain Healthcare Selects Craneware Revenue Integrity Solutions
10. D-M-S Holdings, Inc. Announces the Filing of a Lawsuit Against Veridian Healthcare, LLC, Steven M. Bisulca and Michael Mazza
11. Sanofi-aventis to Acquire Chattem Inc., Creating a Strong U.S. Consumer Healthcare Platform
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/5/2017)... June 5, 2017 The Cincinnati ... Diplomat Pharmacy, Inc. (NYSE: DPLO), has been awarded a ... . Results are based on an employee survey ... health and workplace improvement. The survey measures several aspects of ... ...
(Date:5/30/2017)... , May 30, 2017 DarioHealth Corp. (NASDAQ: DRIO), ... data solutions, today announced that it will be presenting at the ... 8:00 AM PT. Erez Raphael , CEO, of DarioHealth will ... conference will be held on June 6th & 7th, 2017 at ... in the small / micro-cap space. ...
(Date:5/26/2017)... 25, 2017  In response to the opioid epidemic ... Relief is working with Pfizer to make up to ... cost to community health centers, free and charitable clinics, ... "Pfizer has a long-standing commitment to improving ... patient safety through educational activities," said Caroline Roan ...
Breaking Medicine Technology:
(Date:6/27/2017)... Simi Valley, CA (PRWEB) , ... June 27, 2017 , ... ... deployed since 2001 suffer from PTSD. Yet less than 20% will receive adequate care ... of those with PTSD won't receive any care at all. And left untreated, veterans ...
(Date:6/26/2017)... (PRWEB) , ... June 26, 2017 , ... Antoine Dental Center is now ... standard in tooth replacement and act as a support for prosthetic teeth, such as crowns, ... the existing bone and becomes a sturdy, lasting new root for the tooth. , ...
(Date:6/26/2017)... Lake Tahoe, CA (PRWEB) , ... June 26, 2017 , ... ... seeking 10,000 qualified mental health professionals in every state across the country to join ... an easy and rewarding way for therapists to reach a substantially greater number of ...
(Date:6/25/2017)... ... , ... Create a feel-good lyric music video in Final Cut Pro X with ProLyric from ... write in the lyrics to any song. ProLyric flies in the text for each section ... can be added modularly for optimal control. ProLyric makes editing any music video or text-based ...
(Date:6/25/2017)... , ... June 25, 2017 , ... June is Men’s Health Month and ... most common cancer among men in the U.S. and the third most common cause of ... estimated that one man in seven will be diagnosed with prostate cancer during his lifetime. ...
Breaking Medicine News(10 mins):