Study to look into impact of medications taken during pregnancy
Reported January 01, 2010
New York, January 1 — A lot is said and discussed about the advantages of refraining from common medications during pregnancy.
However, very little concrete information is documented as to whether the moms-to-be should miss out on helpful medicines in those critical nine months.
For all those who suffer due to paucity of such information, reliable help is expected soon, for the U.S. Food and Drug Administration has decided to initiate various studies that will look into the safe use of medications in pregnant women.
Joint effort The research program will be known as Medication Exposure in Pregnancy Risk Evaluation Program or MEPREP.
The studies will be conducted by the FDA in collaboration with Kaiser Permanente, Vanderbilt University and a consortium of HMOs called the HMO Research Network Center for Education and Research in Therapeutics or CERT that is managed by Harvard University.
“These data will guide regulatory policy and influence medical practice,” FDA Commissioner Margaret Hamburg said of the studies to be undertaken.
According to the information available, nearly 66 percent of the expecting women take a prescription drug during their pregnancy.
However, only a few formal research studies establish that these medications are innocuous.
The research design The FDA now intends to assess and examine close to one million births that occurred in 2001 through 2007. The investigators will make use of data from 11 research sites in the U.S. affiliated with large health plans.
The medical records for the mothers as well as the babies will be scrutinized for medication use and the resultant consequences.
The studies that cover such a huge database are likely to reveal if the drugs are really safe or dangerous as they are thought to be or is the reality different.
“Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy,” maintains Gerald Dal Pan, MD, director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research.
Till the time the findings of MEPREP are published, physicians will have to rely on the scarce information and their own judgment as to weather the benefits of the prescribed drug outweigh the possible risks.
The FDA has not given a time frame as to when the MEPREP will be completed.
Source : themedguru.com