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FDA Safety Rating | The Role of Teratology Specialists | Chronic Conditions | Risks and Benefits | Herbs

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When planning to start a family, you may question the safety of over-the-counter or prescription drugs. It is important to know the risks of taking certain medications to you and the fetus.

When possible, think ahead. It is best to address questions about medicines and vitamins before you are pregnant. Ask your doctor first about the over-the-counter medicines you currently use. These include drugs for everyday conditions, such as heartburn, allergies, or headaches. In addition, check with your doctor about any prescription medicines you are taking. Both types of medicines may need to be either discontinued or changed before you get pregnant.

FDA Safety Rating

Because of fear of harming unborn baby, drug companies cannot test new medication on pregnant women. Currently, the United States Food and Drug Administration (FDA) requires that drugs be categorized according to their risk to pregnant women.

The FDA uses Pregnancy Exposure Registries to help women and health professionals learn about the effects of medications on pregnancy. These registries record reported incidents of negative or positive reaction of medications in pregnant women. You can register and find information at the FDA website.

The Role of Teratology Specialists

What is teratology? It is the study of birth defects and abnormal development of the fetus during pregnancy. The Organization of Teratology Information Services (OTIS) provides expert information about prenatal exposures to medicines, chemicals, and other substances. OTIS member organizations do not prescribe or recommend treatments; they provide objective information about the following:

  • Medicines a woman took before she realized she was pregnant
  • Medicines prescribed for an illness that occurs during pregnancy
  • Medicines for chronic conditions

Chronic Conditions

Do not stop taking any medications, herbs, or vitamins until your doctor says that it is okay. Stopping medication may be more harmful than taking them. Some chronic conditions that require regular medications include:

Not long ago, many women with chronic conditions, such as lupus or diabetes, considered pregnancy to be too risky. However, because of advances in the fields of high risk obstetrics and internal medicine, many of these women now deliver healthy babies.

In some cases, such as when women have asthma, depression, diabetes, high blood pressure, or HIV, stopping medicine may be significantly more harmful to the fetus than taking the drugs during pregnancy. In these types of cases, OTIS can provide information about a specific drug and the risk to the fetus, based on timing during the pregnancy. Some drugs are potentially harmful early in the pregnancy, but not later on. Conversely, others present a greater risk around the time of delivery. OTIS can also inform you about the risk/benefit profile of medicines that can help you manage your condition during pregnancy.

It may be a good idea to work with a teratology specialist who can help you coordinate a healthcare team to help you manage your medical condition along with your pregnancy.

Members of the team may include:

  • An obstetric care provider who specializes in high risk pregnancies
  • The doctor managing the chronic condition
  • The primary care provider (if not managing the chronic condition or the pregnancy)
  • A genetic counselor

Risks and Benefits

There are several common medications that do not cause birth defects. Others may involve risk, but there is no evidence to support it. Keep in mind that the benefits of taking some medications outweigh the risk of potential harm to the fetus. The FDA classifies risk to pregnancy on the following scale based on fetal harm:

  • A—controlled studies show no risk
  • B—risk unlikely
  • C—risk cannot be ruled out
  • D—positive evidence of risk (maternal benefit may outweigh fetal risk in serious or life threatening situations)
  • X—contraindicated in pregnancy (positive evidence of serious fetal harm)

Here are some of the medications that involve high risk

  • C—Methamphetamine
  • C—Streptomycin
  • D—ACE inhibitors
  • D—Aspirin (not recommended except for certain conditions.)
  • D—Lithium
  • D—Propylthiouracil
  • D—Tetracycline
  • D—Warfarin
  • X—Accutane
  • X—Methotrexate
  • X—Soriatane
  • X—Thalidomide

Non-steroidal anti-inflammatory (NSAIDs) medicines should be avoided in the third trimester. It is best to stop using alcohol, tobacco products, and illicit drugs if you plan on becoming pregnant, suspect pregnancy, or are already pregnant.

If you are taking prescription or over the counter medications, or need to start new ones, check with your doctor to see what options you have available.


Most medical professionals warn pregnant women not to take herbal remedies because there are no reliable studies about their effects during pregnancy. Since they are not regulated the way conventional medicines are, there is no way to gauge the purity or actual dose of the substance you are taking. There may be many alternative and complementary therapies that are safe and/or helpful in pregnancy. Nevertheless, you need to do your research to find out if there is information about their safety in pregnancy, and doctors recommend that you discuss this with them, as well.

Medications and pregnancy are a complicated pair. If you are pregnant, or thinking about it, have a talk with your doctor so you know what is safe for you and your baby.


Organization of Teratology Information Services (OTIS)



US Department of Health & Human Services



Canadian Association of Family Physicians



About Us. Organization of Teratology Information Specialists website. Available at: http://www.otispregnancy.org/faq's-about-otis-s13032#2. Accessed November 28, 2012.

Black R, Hill DA. Over-the Counter Medications in Pregnancy. Am Fam Physician. 2003;67(12):2517-2524.

Medication and Drug Exposure in Pregnancy. EBSCO DynaMed website. Available at: http://www.ebscohost.com/dynamed/what.php. Updated November 2, 2012. Accessed November 28, 2012.

Medicine and Pregnancy. US Food and Drug Administration website. Available at: http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118567.htm. Updated August 23, 2012. Accessed November 28, 2012.

Natural Herbs & Vitamins During Pregnancy. American Pregnancy Association website. http://www.americanpregnancy.org/pregnancyhealth/naturalherbsvitamins.html. Updated July 2011. Accessed November 28, 2012.

Pregnancy Registries. US Food and Drug Administration website. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm251314.htm. July 22, 2011. Accessed November 28, 2012.

Treatments and Discomforts During Pregnancy. EBSCO DynaMed website. Available at: http://www.ebscohost.com/dynamed/what.php. Updated November 2, 2012. Accessed November 28, 2012.

Last reviewed November 2012 by Brian Randall, MD

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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