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Why is taking medication a concern for pregnant and
breastfeeding women?
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Are there times when a pregnant woman must take medication?
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Are new drugs tested for their effects in pregnancy before
they are available to the public?
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How are medications monitored for their effects in pregnancy
after they are available to the public?
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What are the most common medications used by women of
childbearing age?
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Is it safe to take herbals and other dietary supplements during
pregnancy?
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Is it safe to take medications, herbals, or dietary supplements while
breastfeeding?
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What should I do if I am pregnant and have taken a medication, or need
to take a medication?
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What is CDC doing about the issues of medication use in pregnancy?
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What is FDA doing about the issues of medication use in pregnancy?
1. Why is taking medication a concern for pregnant and breastfeeding
women?
We know that taking certain medications – such as thalidomide, isotretinoin
or Accutane© - during pregnancy may cause serious birth defects in the
baby. These medications should be avoided by all pregnant women. However,
we do not have enough information about the safety of many other
medications when they are taken by pregnant women.
Women are often told not to use any medications while pregnant. But this is
not always possible. A survey in the United States in 1998-99 found that
46% of women in their childbearing years (ages 18 to 44) took a
prescription medication during the previous week.1 Many more may use
over-the-counter medications. Also, many women take medications before they
even know they are pregnant. It is important that we know more about which
medications may be harmful during pregnancy and which are not.
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2. Are there times when a pregnant woman must take medication?
Yes. Some pregnant women must take medications to treat health conditions
like asthma, epilepsy (seizures), high blood pressure, depression, and
others. If these conditions are not treated, the mother or the child could
be harmed. It is important when treating these conditions to know which
medications are safest for pregnant women.
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3. Are new drugs tested for their effects in pregnancy before they are
available to the public?
Before a prescription drug is made available to the public, it is tested in
animals – including pregnant animals – to see if there are problems. Then
it is given to people in clinical trials to see how well it treats health
conditions, and to identify any side effects. Pregnant women usually do not
take part in these clinical trials because there might be risks to the
unborn child.
While testing medications in animals can help to identify potential
problems, these tests do not always predict how medications will affect
humans. This is true for pregnant women too – they can have effects that
pregnant animals don’t have. In addition, over-the-counter drugs, vitamins,
and other dietary or herbal supplements are not regularly tested on
animals.
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4. How are medications monitored for their effects in pregnancy after
they are available to the public?
Once a medication is on the market, there are several ways to find out more
about its effects in pregnancy:
1) Adverse event reports – Drug companies are required to report any
problems with medications to the Food and Drug Administration (FDA). Health
care providers, researchers, and the public can also report problems
directly to FDA.
2) Pregnancy Registries - Drug companies sometimes conduct special
studies called pregnancy registries. They enroll pregnant women who have
taken certain medications. Then after birth, their babies are compared to
the babies of women who did not take the medication. For a list of current
pregnancy registries and how to enroll, see
http://www.fda.gov/womens/registries.
3) The Organization of Teratology Information Services (OTIS) - OTIS gives
information to health care providers and pregnancy women about the risks
and safety of taking medications during pregnancy and while breastfeeding.
They also conduct studies of pregnant women who contact them after taking
certain medications. To contact OTIS, go to
http://www.otispregnancy.org.
4) Researchers conduct special studies to identify risk factors for
birth defects and problems during pregnancy, including problems with
medications. The National Birth Defects Prevention Study is one of these.
Click here for more information about this
study.
All these resources collect a lot of information about the risks of using
medications during pregnancy. But much more needs to be learned. A more
coordinated and complete approach is needed to learn more about the effects
of medications on pregnant women and their infants.
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5. What are the most common medications used by women of childbearing
age?
A survey in the United States in 1998-99 found that women in their
childbearing years (ages 18 to 44) took over-the-counter medications more
often than prescription medications.1 Pain medications were the most common
over-the-counter drugs. Next were medications used to treat the common
cold. Many pregnant women may take these medications before they realize
they are pregnant.
Among prescription drugs, birth control pills were used most often by women
in their childbearing years. However, some women have health conditions –
like asthma, epilepsy (seizures), high blood pressure, depression, and
others – for which they must take medication. It is important that we know
whether medications used to treat these conditions could be harmful to
pregnant women, or to their unborn children.
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6. Is it safe to take herbals and other dietary supplements during
pregnancy?
Many herbals and other dietary supplements are made from natural
ingredients, and many people think they are safer than other medications.
However, herbals and other dietary supplements are not regulated by the
FDA. Some could have side effects or other problems. It is important that
we learn more about the effects of herbals and other dietary supplements,
especially their effects on a pregnant woman and her unborn child. You
should talk with your doctor before taking any medications – including
herbals and other dietary supplements – if you are pregnant or could become
pregnant.
Some vitamins are important to a healthy pregnancy. Folic acid is a B
vitamin. It is used by the body to make new cells. If a woman has enough
folic acid in her body before she is pregnant, some major birth defects of
her baby’s brain and spine – called neural tube defects (NTDs) – can be
prevented. Women need to take folic acid every day starting before they are
pregnant to help prevent NTDs. The CDC and the U.S. Public Health Service
urge every woman who could become pregnant to get 400 micrograms (400 mcg)
of synthetic folic acid every day. Most multivitamin preparations contain
this amount of folic acid.
Some vitamins, such as vitamin A, are important to a healthy pregnancy but
can be harmful if taken in high doses. Taking more vitamin A than the
recommended amount could be harmful to an unborn child. It is important to
talk with your doctor before taking any extra vitamins if you are pregnant
or might become pregnant.
For more information about the use of folic acid to prevent birth defects,
go to folic acid and
ABC’s of a healthy pregnancy.
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7. Is it safe to take medications, herbals, or dietary supplements while
breastfeeding?
Breast milk is the healthiest food for babies. It is important that women
do not stop breastfeeding unnecessarily, even though many prescription and
over-the-counter drugs, herbals, and dietary supplements can reach a
nursing baby through breast milk. Fortunately, most medications enter
breast milk in small amounts that won’t affect a nursing baby very much.
However, we need more information about the actual effects of most
medications on nursing babies to be certain they are safe to use while
breastfeeding.
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8. What should I do if I am pregnant and have taken a medication, or
need to take a medication?
The first thing to do is talk with your doctor. Some medications are
harmful when taken during pregnancy, but others are not. The effects depend
on many factors such as: How much was taken, and when during the pregnancy?
Do you have other health conditions? For more information, your doctor may
contact the Organization of Teratology Information Services (OTIS). Go to
http://www.otispregnancy.org.
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9. What is CDC doing about the issues of medication use in pregnancy?
CDC is working to learn more about the effects of taking medications during
pregnancy in several ways. CDC works with the FDA, drug manufacturers, and
other professionals to help conduct studies on the effects of medications
during pregnancy, and ways to prevent harmful effects. CDC funds a large
study of birth defects called the National Birth Defects Prevention Study.
This study is working to find the causes of birth defects and to answer
questions about medications taken during pregnancy. CDC has also sponsored
workshops and seminars about the risks and safety of taking medications
during pregnancy.
For more information about activities of CDC’s National Center on Birth
Defects and Developmental Disabilities related to medications in pregnancy,
go to NCBDDD Activities.
For more information about CDC’s National Birth Defects Prevention Study,
click here.
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10. What is FDA doing about the issues of medication use in pregnancy?
The Food and Drug Administration (FDA) gives information to the public
about the effects of medications, including those taken during pregnancy.
The FDA makes sure that warning labels are included in the packages for
medications, and sends letters to health care providers about possible
problems with medications. FDA also monitors problems that people have
while taking medications, including problems during pregnancy. Sometimes,
the FDA requires drug manufacturers to conduct special studies on mothers
and babies (called pregnancy registries), to monitor the effects of certain
medications after they have been made available to the public.
For more information about the FDA’s activities related to medications in
pregnancy, go to the FDA’s Center for Drug Evaluation Research website at
http://www.fda.gov/cder.
For a list of current pregnancy registries and how to enroll, go to
http://www.fda.gov/womens/registries.
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References
1. Kaufman DW, Kelly JP, Rosenberg L, Anderson TE, Mitchell AA. Recent
patterns of medication use in the ambulatory adult population of the United
States: the Slone survey. JAMA 2002;287(3):337-44.
Date: October 29, 2004
Content source: National Center on Birth Defects and Developmental
Disabilities
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