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
