Proposes New Rule to Provide Updated Information on Use of Prescription Drugs
and Biological Products during Pregnancy and Breast-feeding|
U.S. Food and Drug Administration has recently proposed major revisions to the
physician labeling for prescription drugs (including biological products) to provide
better information about the effects of medicines used during pregnancy and breast-feeding.
The proposed changes
to prescription drug labeling would give health care professionals more comprehensive
information for making prescribing decisions and for counseling women who are
pregnant, breast-feeding, or of child-bearing age about using prescription medications.
labeling is directed to health care professionals, it is sometimes adapted for
use in consumer-directed labeling such as patient package inserts or medication
guides when such labeling is approved for a prescription drug.
this proposal, FDA's goal is to help women, their physicians and their pharmacists
have better information about the effects of prescription medicines so that pregnant
women, nursing mothers, and breast-feeding infants will benefit," said Rear
Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. "This
proposal would help make drug labeling a better communication tool, and would
potentially have a huge impact on public health and well being for women."
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. Additionally,
women with pre-existing medical conditions, such as asthma or high blood pressure,
may need to continue to use prescription drugs to treat those conditions during
proposed rule outlines what important information about the use of medicines during
pregnancy and breast-feeding would be required to be added to product labeling
for newly approved drugs. Under the proposal, drug labeling would explain, based
on available information, the potential benefits and risks for the mother and
the fetus, and how these risks may change during the course of pregnancy.
the 1990s, the FDA recognized the shortcomings of pregnancy and breastfeeding
information in prescription drug labeling and began reviewing ways to improve
the information. The agency held public meetings and focus groups to obtain comment
on the current labeling from health care professionals and scientific experts.
Current labeling uses a letter category system to describe the risks of drug use
during pregnancy. Stakeholders have said the letter category system leads to an
inaccurate and overly simplified view of these risks, and does not facilitate
updating of labeling as new information becomes available.
proposed rule would remove the letter categories from the pregnancy section of
prescription drug labeling. The newly designed format, for the pregnancy section
of the labeling would have three sections:
The first section, called the "Fetal Risk Summary," would describe what
is known about the effects of the drug on the fetus, and if there is a risk, whether
this risk is based on information from animals or humans. The proposal calls for
a risk conclusion based on the available data and provides a number of examples
depending on the quality and quantity of that data. For example, one risk conclusion
might be: "Human data indicate that (name of drug) increases the risk of
cardiac abnormalities." This would be followed by a summary of the most important
data on the drug's effects.
Another section, called "Clinical Considerations,"
would include information about the effects of the use of the drug if it is taken
before a woman knows she is pregnant. This section also would feature discussions
about the risks of the disease to the mother and the baby, dosing information,
and tell how to address complications.
The third section, under the heading
"Data," would describe in more detail the available data regarding use
of the drug in humans and from animal studies that were used to develop the Fetal
pregnancy section would also include information about whether there is a pregnancy
exposure registry for the drug. Pregnancy exposure registries collect and maintain
data on the effects of approved drugs that are prescribed to and used by pregnant
The lactation (breastfeeding) section of prescription drug labeling
would use the same format as the pregnancy section. The lactation section would
provide information about using the drug while breastfeeding, such as the amount
of drug in breast milk and potential effects on the breastfed infant.
newly approved drugs would use the new pregnancy and lactation labeling format,
while labeling for previously approved drugs will be phased in gradually under
FDA's recent Physician Labeling Rulemaking.
comments can be submitted within 90 days via the Federal Documents Management
System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider
the comments in preparing a final rule.
Food and Drug Administration. FDA Proposes New Rule to Provide Updated Information
on the Use of Prescription Drugs and Biological Products during Pregnancy and
Breast-feeding. Press release. May 28, 2008.