Taking Psychiatric Drugs During Pregnancy Can Cause Birth Defects and Deaths

FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy
by Sheila Sullivan on January 6, 2010

The FDA has finally ordered the first test ever done on the effect of drugs on mothers and their babies during and following births. This is a seven year study that will mostly validate what women who have lost babies and had babies born with heart defects already know – that all drugs taken during pregnancy pose a risk to the mother and the baby and it’s been a well known fact for years that psychiatric drugs do cause birth defects and deaths.

Although this study comes too late for many unborn babies and those who have been through heart surgeries and other birth defects known for years to be caused especially by psychiatric drugs, this is a beginning. The greatest challenge in this study is that they have never done a single study to determine the effect that psychiatric drugs have on the mothers’ or babies’ brains and how this could lead to a drug dependency dependency and neurological damage for the babies.

It’s a bit shocking to hear so many pregnant women are taking drugs during pregnancy. We can thank those psychologists and psychiatrists who have made women feel falsely safe about taking psychiatric drug during pregnancy.

This should be a wake up call for those psychologists and psychiatrists and bloggers who write books and posts that promote the use of psychiatric drugs during pregnancy when there has never been a study done.


For Immediate Release: Dec. 30, 2009

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

FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy
New collaborative research program to study effects on mothers and their babies

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.

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.


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