During pregnancy, women may need medical care that
requires the use of medications or supplements,
either by prescription or over-the-counter. Giving
medications to a pregnant woman can effect the
health of her fetus. Similarly, there are times
when the fetus needs medication for some reason.
Giving medication to a fetus in the womb can also
have effects on the mother\'s health.

Despite these needs, very few of the medications
and supplements available today have been tested
in pregnant women, to determine their safety and
effectiveness for both mother and fetus. Without
evidence on drug safety in pregnant women, health
care providers can\'t be sure they\'re making safe
recommendations to their patients about
medications and supplements.

The Food and Drug Administration (FDA), the
government agency with primary responsibility for
labeling medications and supplements, has joined
the NICHD in searching for a solution to this
potentially dangerous situation.

The FDA is working to change existing drug
regulations in regard to use in pregnant women.
With these changes, drug companies will have to
provide evidence that a drug is safe for both
mother and fetus before it can receive proper
labeling.

For its part, the NICHD has started the
Obstetric-Fetal Pharmacology Research Unit program
to support new research on the safety and
effectiveness of medications used during
pregnancy.

This new research effort will rely on clinical
sites around the country to conduct clinical
trials in pregnant women to:

Find out how drugs affect pregnant women, at
different stages of pregnancy;
Figure out what effects, if any, these drugs have
on the growing fetus, at different stages;
Determine safe and effective doses for medications
used in pregnant women; and
Inform health care providers about drug testing in
pregnant women and which drugs have been proven
safe and under what circumstances.
The NICHD will sponsor a scientific workshop on
the Obstetric-Fetal Pharmacology Research Unit
program in late 2003, to develop a research plan
and discuss partnering with professional
organizations to help this research advance. The
NICHD and the FDA remain committed to this
important work.

Source: National Institute of Environmental Health Sciences, National Institutes of Health, U.S. Department of Health and Human Services.