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Medicines and Labels
Prescription Medicines
The FDA chooses a medicines letter
category based on what is known about the medicine when used in pregnant women
and animals.
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Pregnancy Category
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Definition
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Examples of Drugs
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A
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In human studies, pregnant women used the medicine and their babies did
not have any problems related to using the medicine.
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- Folic acid
- Levothyroxine (thyroid
hormone medicine)
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B
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In humans, there are no good
studies. But in animal studies, pregnant animals received the medicine,
and the babies did not show any problems related to the medicine.
Or
In animal studies, pregnant
animals received the medicine, and some babies had problems. But in human
studies, pregnant women used the medicine and their babies did not have
any problems related to using the medicine.
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- Some antibiotics like
amoxicillin.
- Zofran® (ondansetron)
for nausea
- Glucophage® (metformin)
for diabetes
- Some insulins used to
treat diabetes such as regular and NPH insulin.
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C
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In humans, there are no good
studies. In animals, pregnant animals treated with the medicine had some
babies with problems. However, sometimes the medicine may still help the
human mothers and babies more than it might harm.
Or
No animal studies have been
done, and there are no good studies in pregnant women.
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- Diflucan® (fluconazole)
for yeast infections
- Ventolin® (albuterol)
for asthma
- Zoloft® (sertraline)
and Prozac® (fluoxetine) for depression
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D
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Studies in humans and other
reports show that when pregnant women use the medicine, some babies are
born with problems related to the medicine. However, in some serious
situations, the medicine may still help the mother and the baby more than
it might harm.
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- Paxil® (paroxetine)
for depression
- Lithium for bipolar
disorder
- Dilantin® (phenytoin)
for epileptic seizures
- Some cancer chemotherapy
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X
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Studies or reports in humans
or animals show that mothers using the medicine during pregnancy may have
babies with problems related to the medicine. There are no situations
where the medicine can help the mother or baby enough to make the risk of
problems worth it. These medicines should never be used by pregnant women.
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- Accutane® (isotretinoin)
for cystic acne
- Thalomid®
(thalidomide) for a type of skin disease
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The FDA is working hard to gather
more knowledge about using medicine during pregnancy. The FDA is also trying to
make medicine labels more helpful to doctors. Medicine label information for
prescription medicines is now changing, and the pregnancy part of the label will
change over the next few years.
Over-the-Counter (OTC) Medicines
All OTC medicines have a Drug
Facts label. The Drug Facts label is arranged the same way on all OTC
medicines. This makes information about using the medicine easier to find. One
section of the Drug Facts label is for pregnant women. With OTC
medicines, the label usually tells a pregnant woman to speak with her doctor
before using the medicine. Some OTC medicines are known to cause certain
problems in pregnancy. The labels for these medicines give pregnant women facts
about why and when they should not use the medicine. Here are some examples:
- Nonsteroidal
anti-inflammatory drugs (NSAIDs) like ibuprofen (Advil®, Motrin®),
naproxen (Aleve®), and aspirin (acetylsalicylate), can cause serious blood
flow problems in the baby if used during the last third of pregnancy (after
28 weeks). Also, aspirin may increase the chance for bleeding problems in
the mother and the baby during pregnancy or at delivery.
The labels for nicotine therapy drugs, like the
nicotine patch and lozenge, remind women that smoking can harm an unborn child.
While the medicine is thought to be safer than smoking, the risks of the
medicine are not fully known. Pregnant smokers are told to try quitting without
the medicine first.
** Find out more about pregnancy and medicines from:
The National Women's Health Information Center (NWHIC)
Toll Free:(800) 994-9662
Internet Address: http://www.womenshealth.gov/pregnancy/pregnancy/
Food and Drug Administration
Phone Number(s): (888) 463-6332 (Consumer Information)
Internet Address: http://www.fda.gov
Food and Drug Administration
Office of Women's Health
General Information about Pregnancy Exposure Registries
Internet Address: http://www.fda.gov/womens/registries/default.htm
Source: The National Women's Health Information Center (NWHIC)
http://www.womenshealth.gov/pregnancy/pregnancy/
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