The
Division of Drug Information (DDI) is CDER's focal point for public
inquiries. We serve the public by providing information on human drug
products and drug product regulation by FDA.
The U.S. Food and Drug Administration today 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.
Although physician 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.
The 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 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 Risk
Summary.
The 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 women.
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.
Certain 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.
Electronic 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.
For more information, visit:
http://www.fda.gov/cder
/regulatory/pregnancy_labeling
/default.htm
1.
What is FDA announcing today?
FDA
is proposing major revisions to prescription drug labeling concerning
drug use during pregnancy and breast-feeding. FDA’s proposed rule would
require more complete information about the use of drug and biologic
products by women of childbearing age, pregnant women, and women who
choose to breast-feed.
2.
What are the major changes that are being proposed?
Today’s
proposed revisions to prescription drug labeling represent a major
milestone, because the new labeling would provide available scientific
data and information - in a clear and accessible format - about the use
of drugs by pregnant and nursing women. The new labeling format will
include a risk summary and information about available data on use of
the drug during pregnancy and while breastfeeding, to help health care
providers counsel pregnant women, nursing women, and all women of
reproductive age about the use of prescription drugs and biologics.
Among the major changes will be the elimination of the letter category
system, which frequently has been criticized as misleading and overly
simplistic. The proposed new labeling format will be based on the most
relevant scientific data available, and will provide information
specifically intended to address the special health needs of pregnant
and nursing women.
3. What drugs will be affected by this rule?
The
revised pregnancy and lactation formats would be used for drugs
approved after the final rule becomes effective, as well as for
previously approved drugs that are subject to the FDA’s recent
physician labeling rulemaking. For those previously approved drugs
subject to the physician labeling rulemaking, the revised formats would
be implemented over a period of years. In addition, the current system
of letter categories relating to use of the drug in pregnant women
would be eliminated from the labeling of all approved drugs.
4.
What is FDA's goal for the new labeling format?
FDA’s
goal is to give health care providers better information about the use
of prescription drugs during pregnancy and breast-feeding. We believe
that better information will help healthcare practitioners, in
consultation with their patients, make more informed choices about
which drugs to prescribe during pregnancy and breast-feeding. The more
detailed information that this labeling will ultimately provide should
also help health care providers counsel women who took a drug before
they knew they were pregnant.
5.
How would this proposed rule benefit women who are pregnant or breast-feeding?
Prescription drug labeling is written for doctors and other healthcare
practitioners, who use the information to counsel and advise their
patients about which drugs to use. In consultation with their
healthcare practitioners, women may use this information to make
important decisions about medicine use during pregnancy and while
breast-feeding, as well as more generally during their child-bearing
years, with the possibility that they may become pregnant in the
future. In situations when a woman becomes pregnant unexpectedly, the
more detailed labeling information that would be required by the
proposed rule would help healthcare practitioners explain what is known
about the possible effects of a drug on an early pregnancy. For women
who need to continue a medicine or start a medicine while
breastfeeding, this information would help a woman and her baby’s
pediatrician determine the possible effects of the medicine on the baby
and whether it would be better for the baby’s health overall to
breast-feed or to formula feed.
6. Where will the data in the prescribing information come from?
The
data could come from various sources, including studies published in
the medical literature about the use of prescription drugs during
pregnancy and breast-feeding. Companies would be required to include
clinically relevant information from such published studies in the
labeling. Another source of data could be from pregnancy exposure
registries, which are conducted by some companies to collect
information on the effects of their approved drugs when those drugs are
used by pregnant women to treat a medical condition
7. What is a pregnancy exposure registry?
Pregnancy
exposure registries are studies that collect and maintain data on the
effects of drugs and vaccines that are used by pregnant women. These
registries do not require women to take an experimental drug or a drug
they would not ordinarily take. Instead, the registries collect
information on the effects of already approved drugs prescribed to
pregnant women by their doctors. FDA encourages drug companies to
maintain pregnancy exposure registries, and has issued a guidance
advising drug manufacturers how to conduct a pregnancy exposure
registry. http://www.fda.gov/cder/guidance/3626fnl.htm
8. Does the proposed labeling format include information on pregnancy exposure registries?
Yes,
under the proposed rule, the pregnancy subsection of the labeling would
be required to include information on any pregnancy registry that had
been established for the drug.
9.
Where can I learn more about pregnancy exposure registries?
If
you are pregnant and want to know more about participating in a
pregnancy exposure registry, visit the Office of Women’s Health website
at: http://www.fda.gov/womens/registries/default.htm.
This page includes a list of all active pregnancy exposure registries.
Women can enroll themselves in many cases, but in some cases they may
have to work with a health care professional to enroll.
10.
What are some of the major concerns in treating pregnant women who have
chronic diseases or pregnant women who need immediate treatment for an
acute condition?
Frequently,
women with chronic diseases need to take prescription drugs to manage
their medical problems, and they may need to continue taking those
drugs when they are pregnant. Pregnant women can develop acute medical
problems that require immediate treatment, such as kidney infections,
upper respiratory infections, gastro-esophageal reflux (GERD), and
other conditions, just like individuals who are not pregnant. Pregnant
women also can develop problems directly related to their pregnancy,
such as severe nausea and vomiting, gestational diabetes or
pregnancy-induced hypertension (high blood pressure). These medical
problems often require treatment with prescription drugs.
The
major challenge when treating pregnant women is one of balance – a
balance between possible harms and benefits to both the mother and
fetus (developing baby). Although using a prescription drug may pose a
risk to the pregnant woman and her fetus, there can also be risks
associated with not treating an illness. Using a prescription drug to
treat an illness can offer benefit by preventing the harm caused by the
illness itself.
Frequently, there is little
information available about the effects of using a prescription drug
during pregnancy or while breast-feeding, and what information there is
often becomes available only after a product is approved and marketed.
It is often scattered in the medical literature and does not get
incorporated in labeling. The proposed rule would address this by
requiring that available information about the effects of a drug on
pregnancy and lactation be actively sought and, when appropriate, be
included in the labeling, in a revised format that would make that
information more useful to healthcare practitioners and their
patients. In addition, the labeling would specifically state when
there is not information available.
11.
What progress has FDA made recently in updating drug labeling with information on the use of drugs in pregnancy?
In
recent years FDA has been working to develop more comprehensive
information about pregnancy in labels for individual drugs as important
studies have appeared in the literature. For example, in 2001, when
letters containing anthrax spores were mailed to Congressional and news
media offices, the Centers for Disease Control and Prevention
recommended the use of doxycycline, ciprofloxacin, and amoxicillin for
treatment or prophylaxis following anthrax exposure. FDA received
large numbers of questions about the safety of prescribing these drugs
to pregnant women. FDA staff searched the published medical literature
for information on the use of these drugs during pregnancy and provided
that information to the public on FDA's website. Eventually, the
companies that make these three drugs added certain information about
the use of the drugs by pregnant women to the labeling for the
products. Since that time, FDA has continued to work with companies to
include human data about the use of drugs in pregnancy in drug labeling.
12.
When will this rule take effect?
The
version of the rule being published today is only a proposal. FDA
expects to receive numerous comments on the proposed rule, and those
comments will need to be considered carefully before we publish a final
rule. This process will take some time.
