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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

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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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This page last updated March 19, 2004

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