FDA to study effects of medication during pregnancy

pharmafile | January 20, 2010 | News story | Research and Development, Sales and Marketing |  FDA, paediatric 

A new US-based collaborative research programme to study the effects of medication on mothers and their babies has been launched.

The Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy.

The collaboration brings together the FDA and researchers at the HMO Research Network Centre for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centres and Vanderbilt University.

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

Advertisement

To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research will link health care information for mothers and their babies in each of the 11 participating research sites.

About two-thirds of women who give birth take at least one prescription medication during pregnancy but very few clinical trials test the safety of medications in pregnancy due to concerns about the health of the mother and child.

Related Content

FDA grants De Novo authorisation to light-filtering device for migraine

The US Food and Drug Administration (FDA) has granted De Novo marketing authorisation to Avulux, …

EndoCyclic New Drug application approved by US FDA for endometriosis treatment

EndoCyclic Therapeutics’ Investigational New Drug (IND) application for its lead programme, ENDO-205, has been approved …

MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance

Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …

The Gateway to Local Adoption Series

Latest content