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Div. of Media Relations
1600 Clifton Road
MS D-14
Atlanta, GA 30333
(404) 639-3286
Fax (404) 639-7394 |
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Fact Sheet
| March 19, 2004 |
Contact: CDC Division of
Media Relations
(404) 639-3286 |
Loratadine and Hypospadias
Data from the National Birth Defects Prevention Study
MMWR Article
- The MMWR article showed no association between use of loratadine in
early pregnancy and the occurrence of the birth defect hypospadias. The
article was in response to a public health concern, raised by a scientific
study showing a possible association between the drug loratadine, also
sold under the brand name Claritin®, and hypospadias. Because loratadine
is commonly used by reproductive-aged women, inadvertent exposures would
be expected to occur among women who do not yet realize they are pregnant.
- Hypospadias is a birth defect in which the urethral opening is not at
the tip but instead is located somewhere along the length of the underside
of the penis or scrotum. Hypospadias affects approximately 4 out of every
1,000 infants in the United States and requires surgery.
- This information will be useful to any woman who took loratadine and
is worried about her pregnancy. It remains important, however, that a
woman check with her doctor before using any medication during pregnancy.
Medication Use During Pregnancy
- Exposure to medication during pregnancy is common. A woman in the
United States will fill an average of three non-vitamin prescriptions
during her pregnancy, and over-the-counter medication use is even more
frequent.
- Medications might be used in early pregnancy because a woman may not
yet know she is pregnant. In other cases, a woman might have to take
medications during pregnancy to treat an acute or a chronic disease, such
as a bladder infection or epilepsy.
- The effects of most medications on the unborn child are not well
known. This lack of information limits the counseling that can be offered
to a woman after an inadvertent exposure or in making choices about the
best medication to use to treat a serious maternal condition during
pregnancy.
- A woman who has taken medication during pregnancy might experience
stress and anxiety because the effect of the drug on her unborn child is
unknown. Alternatively, she might forgo critical medicine because of
concerns about the safety of her unborn child.
National Birth Defects Prevention Study (NBDPS)
- CDC initiated a national monitoring study capable of providing
information that will allow a response to concerns about the safety of
medications and other exposures in pregnancy in1997. Conducted in
collaboration with nine centers in different regions of the United States,
this study is called the National Birth Defects Prevention Study (NBDPS).
- The NBDPS interviews mothers of children with birth defects and
mothers of children without birth defects and compares their answers to
identify potential exposures. More than 16,000 mothers have been
interviewed to date.
- Coordinating activities into a comprehensive public health approach
will help provide the best possible information for making decisions about
the use of medications during pregnancy. This is an important CDC goal.
For more information, visit
www.cdc.gov/ncbddd.
# # #
The Centers for Disease Control and Prevention (CDC)
protects people's health and safety by preventing and controlling diseases
and injuries; enhances health decisions by providing credible information on
critical health issues; and promotes healthy living through strong
partnerships with local, national, and international organizations.
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