- WEDNESDAY, May 28 (HealthDay News) — U.S. health officials
proposed Wednesday changes to the labels on prescription drugs that would
detail potential health effects for pregnant and breast-feeding women,
their fetuses or their newborns.

If enacted, the new system, proposed by the U.S. Food and Drug
Administration, would provide doctors and pharmacists with more
comprehensive information to guide them in their prescribing
practices.

“The most important tool the FDA has to carry out its mission to
protect and promote the health of every single American is the legal
authority we've been given to determine the content and the format of
labeling,” FDA Commissioner Dr. Andrew C. von Eschenbach said during a
teleconference.

The proposed system would replace the current system that relies on
letter designations to describe the risks of a drug when taken during
pregnancy or breast-feeding. This system was deemed confusing and
incomplete.

“The system of letter categories has led to an inaccurate and overly
simplified view of prescribing in pregnancy,” Dr. Sandra Kweder, deputy
director of FDA's Office of New Drugs, Center for Drug Evaluation and
Research, said during the teleconference. “This system also makes it very
difficult to update labeling as new information becomes available,” she
added.

There are about six million pregnancies in the United States every
year, and pregnant women take an average of three to five prescription
drugs during pregnancy. Also, women with pre-existing medical conditions,
such as asthma or high blood pressure, may need to use prescription drugs
to treat those conditions during pregnancy, the FDA noted.

Under the new proposal, drug labeling would explain the potential
benefits and risks for the mother, her fetus or her new baby, and how
these risks change over the course of pregnancy, Kweder said.

New drug labels would include three sections devoted to pregnancy and
breast-feeding. The first section, called the “Fetal Risk Summary,” would
describe what's known about the effects of a drug on the fetus and whether
the risk is based on results of animal studies or human studies.

The second section, called “Clinical Considerations,” would include
information about effects associated with the drug if it were taken before
a woman knows she is pregnant. This section would also outline risks of
the disease to the mother and baby, dosing information and how to address
complications.

The final section, called “Data,” would describe in detail the
available information about the drug's use in humans and animals studies
used in developing the “Fetal Risk Summary.”

The breast-feeding section of the label would use the same format as
the pregnancy section and provide information about using the drug while
nursing, Kweder said.

The FDA began work on redesigning labels of prescription drugs' effects
during pregnancy and breast-feeding in 1997. The proposed changes
announced Wednesday will undergo a review process, with the agency
receiving comments from various stakeholders. Once that review has been
completed, the FDA will incorporate the comments and come up with a final
version of the labels. This process could take up to one year to finish,
officials said.

Once the rule takes effect, new drugs would have to conform immediately
to the revised labeling standard, Kweder said. For older drugs, the label
requirements would be phased in over time. It will take several years for
all drugs to comply with the new label standard, she said.

More information

For more on prescription drugs and pregnancy, visit the U.S. Department
of Health & Human Services.