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New Study Focuses on Effects of Prescription Medication on Pregnant Mom and Child

By Paul Napoli

December 31, 2009

The U.S. Food and Drug Administration (FDA) announced a new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP), which will fund research to study the effects of prescription medications when used during pregnancy.

An article published in the American Journal of Obstetrics and Gynecology states about two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy. Clinical data about the effects of those prescription medications are largely unknown. Pregnant women are underrepresented in clinical drug studies because of safety concerns about adverse drug effects upon the mother and child.

Researchers from the FDA, HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente's multiple research centers and Vanderbilt University will study health care data for about 1 million mothers and their babies from 2001 to 2007.

'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."

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, Tennessee State Medicaid and the FDA.

A Steering Committee composed of representatives from each participating site and the FDA will oversee MEPREP activities and provide overall scientific leadership. 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.

'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.'

Prescription drugs taken during pregnancy may cause a variety of adverse effects, including mild to severe birth defects or child development problems. If you or your child has experienced a medication-related injury or adverse drug effect related to prescription medication taken during pregnancy, you may be entitled to compensation. Attorneys at Napoli Bern Ripka, LLP are experienced in dangerous prescription drug litigation and fight for you against the big drug companies. Call 888.529.4669 today.

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on January 03, 2010 (boomark / email).