Medication Use During Pregnancy

The safety of most medications taken by pregnant women is unknown and dependent on many factors. Talk with your doctor if you are pregnant or planning a pregnancy.

Talk with your doctor if you are pregnant and you have taken any medication or are thinking of taking any medication. This includes prescription and over-the-counter medications, as well as dietary or herbal products. Pregnant women should not stop or start taking any type of medication that they need without first talking with a doctor. Women who are planning to become pregnant should discuss the need for any medication with their doctor before becoming pregnant and ensure they are taking only medications that are necessary.

What Medications Can Cause Birth Defects?

We know that taking certain medications during pregnancy can cause serious birth defects. Examples are thalidomide (also known as Thalamid®) and isotretinoin (also known as Accutane®). Such medications should be avoided by all women who are or might become pregnant. While some medications are known to be harmful when taken during pregnancy, the safety of most medications taken by pregnant women has been difficult to determine. The effects depend on many factors, such as:

• How much medication was taken.
• When during the pregnancy the medication was taken.
• Other health conditions a woman might have.
• Other medications a woman takes.

The Centers for Disease Control and Prevention’s (CDC) National Birth Defects Prevention Study (NBDPS) works to identify possible risk factors for birth defects, including the effects of taking certain medications during pregnancy. For more information about the NBDPS, visit the NBDPS website.

Talk With Your Doctor

Some pregnant women must take medications to treat health conditions such as asthma, epilepsy (seizures), high blood pressure, and depression. If these conditions are not treated, a pregnant woman or her unborn baby could be harmed. It is important that women discuss with their doctor which medications are needed during pregnancy and which are likely to be the safest to take during pregnancy. It is important to balance the possible risks and benefits of any medication being considered.

In addition, women sometimes take medications before they realize that they are pregnant. When this happens, they may worry about the effects of these medications on their unborn child. The first thing a woman who is pregnant or who is planning on becoming pregnant should do is talk with her doctor. Some medications are harmful when taken during pregnancy, but others are not.

Where Can I Find Information About the Effects of Medication Use During Pregnancy?

The U.S. Food and Drug Administration (FDA) regulates medications to ensure their general safety and effectiveness. All prescription and over-the-counter medications are tested to see if they are safe and effective before they become available to the public. Pregnant women usually are not included in these tests because of the possible risks to the unborn child. As a result, little information is available about the safety of most medications during pregnancy—including those available over the counter—when they first become available. It is important to know that dietary and herbal products also could be harmful to an unborn baby or have other side effects when used during pregnancy.

Pregnant animals sometimes are studied to help identify harmful medications. But animal studies do not always show how medications will work in humans. They might miss some harmful effects that medications have. And, over-the-counter medications, vitamins, and dietary or herbal products are not always tested in animals.

There are several ways to find out more about the effects a medication might have when taken during pregnancy:

The Organization of Teratology Information Specialists (OTIS)

The Organization of Teratology Information Specialists (also known as OTIS) gives information to health care providers and pregnant women about the risks and safety of taking medications during pregnancy and while breastfeeding. OTIS also conducts studies of pregnant women who contact them after having taken certain medications.

Adverse Event Reports

Drug companies are required to report any problems with medications to the FDA. Health care providers, researchers, and the public, including pregnant women, also can report problems directly to the FDA MedWatch Program.

Pregnancy Registries

Drug companies sometimes conduct special studies using pregnancy registries. They enroll pregnant women who have taken a certain medication. Then, after these women give birth, the health of their babies is compared with the health of the babies of women who did not take the medication. For a list of current pregnancy registries and how to enroll, individuals may visit the FDA Pregnancy Registry website.

National Birth Defects Prevention Study: Medications and Birth Defects

The Centers for Disease Control and Prevention’s (CDC) National Birth Defects Prevention Study (NBDPS) works to identify possible risk factors for birth defects, including the effects of taking certain medications during pregnancy. For more information about the NBDPS, visit the NBDPS website.