Many women need to take medicine while they are pregnant. Some women take medicines for health problems, like diabetes or high blood pressure, that can start or get worse when a woman is pregnant. Some women use medicine before they find out they are pregnant.

A pregnancy exposure registry is a study that collects health information from women who take prescription medicines or vaccines when they are pregnant. Information is also collected on the newborn baby. This information is compared with women who have not taken medicine during pregnancy.

Enrolling in a pregnancy exposure registry can help improve safety information for medicines used during pregnancy and can be used to update drug labeling. Learn more about how you can help.

The FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule).

The PLLR requires changes to the content and format for information presented in prescription drug labeling in the Physician Labeling Rule (PLR) format to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children. The PLLR removes pregnancy letter categories – A, B, C, D and X. The PLLR also requires the label to be updated when information becomes outdated.

Below is a comparison of the current prescription drug labeling with the new PLLR labeling requirements.

The Pregnancy subsection (8.1) includes information for a pregnancy exposure registry for the drug when one is available. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women. Information about the existence of any pregnancy registries in drug labeling has been recommended but not required until now. Information in the Pregnancy sub-section includes a Risk Summary, Clinical considerations, and Data. Information formerly found in the “Labor and delivery” subsection is now included in the “Pregnancy” subsection.

The Nursing mothers subsection was renamed, the Lactation subsection (8.2), and provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

The Females and Males of Reproductive Potential subsection (8.3), new to the labeling, includes information, when necessary, about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Labeling for over-the-counter (OTC) medicines will not change; OTC drug products are not affected by the final rule.

The National Pregnancy Registry for Antidepressants (NPRAD) is dedicated to evaluating the safety of antidepressant medications that may be taken during pregnancy to treat a wide range of mood, anxiety, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy.

TO PARTICIPATE CALL TOLL-FREE: 1-866-961-2388

All pregnant people 45 and younger with a history of psychiatric illness are eligible to enroll in the registry. If you are interested in participating in the National Pregnancy Registry, please call the toll-free number above or fill out this Participant Interest Form to be contacted by a member of our research team. All information is kept strictly confidential.

Antidepressants of interest to the National Pregnancy Registry include:

• Celexa (citalopram)
• Lexapro (escitalopram)
• Luvox (fluvoxamine)
• Paxil (paroxetine)
• Prozac (fluoxetine)
• Zoloft (sertraline)
• Cymbalta (duloxetine)
• Effexor (venlafaxine)
• Fetzima (levomilnacipran)
• Pristiq (desvenlafaxine)
• Serzone (nefazodone)
• Anafranil (clomipramine)
• Asendin (amoxapine)
• Elavil (amitriptyline)
• Ludiomil (maprotiline)
• Norpramin (desipramine)
• Pamelor (nortriptyline)
• Sinequan (doxepin)
• Surmontil (trimipramine)
• Tofranil (imipramine)
• Vivactil (protriptyline)
• Marplan (isocarboxazid)
• Nardil (phenelzine)
• Parnate (tranylcypromine)
• Brintellix (vortioxetine)
• Desyrel (trazodone)
• Remeron (mirtazapine)
• Wellbutrin (buproprion)
• Spravato (esketamine)
• Zulresso (brexanolone)

Required Sponsorship Disclosures:

Current Sponsors: Alkermes, Inc. (2016-Present); Eisai Inc. (2022 – Present); Johnson & Johnson/Janssen Pharmaceuticals, Inc (2019-Present); Otsuka America Pharmaceutical, Inc. (2008-Present); Sage Therapeutics (2019-Present); Supernus Pharmaceuticals (2021-Present); Teva Pharmaceutical Industries Ltd. (2018-Present).

Past Sponsors: Forest/Actavis/Allergan (2016-2018, declined to sponsor: 2018-Present); Aurobindo Pharma (2020-2022, declined to sponsor: 2022-Present); AstraZeneca Pharmaceuticals (2009-2014, declined to sponsor: 2014-Present); AuroMedics Pharma LLC (2021-2022, declined to sponsor: 2022-Present); Ortho-McNeil-Janssen Pharmaceuticals, Inc (2009-2014, declined to sponsor: 2015-Present); Pfizer, Inc. (2009-2011, declined to sponsor: 2012-Present); Sunovion Pharmaceuticals, Inc. (2011-2023). The Center for Women’s Mental Health participated as a site in the Sage SKYLARK 2020 clinical trial.

Declined to sponsor: AbbVie Inc.; Apotex Inc.; Eli Lilly and Company; Intra-Cellular Therapies, Inc.; Novartis Pharmaceuticals; Vanda Pharmaceuticals Inc; Arcolab Private Limited.

Funding Information: Manufacturers of psychiatric medications have been approached regarding funding of the National Pregnancy Registry. Regardless of which entities have supported this initiative, all medications in this class are studied. For more information on how to sponsor the Registry, please see the contact information below.

The National Pregnancy Registry for Atypical Antipsychotics is dedicated to evaluating the safety of atypical antipsychotic medications that may be taken during pregnancy to treat a wide range of mood, anxiety, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.

TO PARTICIPATE CALL TOLL-FREE: 1-866-961-2388

All pregnant people 45 and younger with a history of psychiatric illness are eligible to enroll in the registry. If you are interested in participating in the National Pregnancy Registry, please call the toll-free number above or fill out this Participant Interest Form to be contacted by a member of our research team. All information is kept strictly confidential.

Antipsychotics of interest to the National Pregnancy Registry include:

• Abilify (aripiprazole)
• Aristada (aripiprazole lauroxil)
• Aristada Initio (aripiprazole lauroxil)
• Geodon (ziprasidone)
• Invega (paliperidone)
• Latuda (lurasidone)
• Lybalvi (olanzapine & samidorphan)
• Rexulti (brexpiprazole)
• Risperdal (risperidone)
• Seroquel (quetiapine)
• Symbyax (olanzapine & fluoxetine)
• Zyprexa (olanzapine)

Required Sponsorship Disclosures:

Current Sponsors: Alkermes, Inc. (2016-Present); Eisai Inc. (2022 – Present); Johnson & Johnson/Janssen Pharmaceuticals, Inc (2019-Present); Otsuka America Pharmaceutical, Inc. (2008-Present); Sage Therapeutics (2019-Present); Supernus Pharmaceuticals (2021-Present); Teva Pharmaceutical Industries Ltd. (2018-Present).

Past Sponsors: Forest/Actavis/Allergan (2016-2018, declined to sponsor: 2018-Present); Aurobindo Pharma (2020-2022, declined to sponsor: 2022-Present); AstraZeneca Pharmaceuticals (2009-2014, declined to sponsor: 2014-Present); AuroMedics Pharma LLC (2021-2022, declined to sponsor: 2022-Present); Ortho-McNeil-Janssen Pharmaceuticals, Inc (2009-2014, declined to sponsor: 2015-Present); Pfizer, Inc. (2009-2011, declined to sponsor: 2012-Present); Sunovion Pharmaceuticals, Inc. (2011-2023).

Declined to sponsor: AbbVie Inc.; Apotex Inc.; Arcolab Private Limited; Eli Lilly and Company; Intra-Cellular Therapies, Inc.; Novartis Pharmaceuticals; Qilu Pharmaceutical Co., Ltd.; Vanda Pharmaceuticals Inc.

Funding Information: Manufacturers of psychiatric medications have been approached regarding funding of the National Pregnancy Registry. Regardless of which entities have supported this initiative, all medications in this class are studied. For more information on how to sponsor the Registry, please see the contact information below.

Get Involved

Share your experience with medicines. Sign up for a pregnancy exposure registry. You can help other pregnant women and doctors find out more about the safety of medicines used during pregnancy.

Pregnancy Exposure Registries gather information about how prescription drugs or vaccines affect a pregnant woman and her fetus. You will not be asked to take any new medicines to participate in the study. The pregnancy registry is only interested in medicines that you are already taking.

FDA does not run the pregnancy registry studies. The drug company that makes the medicine is usually in charge of the pregnancy registry. FDA keeps a list of ongoing registries.

How To Sign Up

1. Check the list of registries. Look for your medicine or medical condition.
2. Get the website and phone number to contact the registry to sign up. For some registries, your doctor, nurse, or midwife may need to sign you up.
3. Ask what to expect when you sign up. Each registry has its own policies. When you contact the registry, ask about their policies such as:
   • How many times will they contact you?
   • How will they keep your information private?
   • Who do you contact if you have questions?
   • How do you find out the results of the study when the registry has ended?

Other Drug Information

If you do not see your medicine on the list, then there may not be a pregnancy registry for that medicine. You may find other information about your medicine at:

• Medication Guides - Information handouts that come with some prescription medicines.
• Drug Specific Information - List of information on some FDA-approved drugs.
• Daily Med - National Library of Medicine website where you can find information from the drug labels for over 20,000 drugs.
• MotherToBaby, a service of the Organization of Teratology Information Specialists (OTIS) - Call MotherToBaby to speak with a counselor about taking medicines while you are pregnant or breastfeeding. 1-866-626-6847

Better Drug Information is Coming

Prescription drug labeling will be changing over the next few years.

Until now, FDA categorized the risks of taking a drug or biological product during pregnancy under a five-letter system (A, B, C, D and X) based on what was known about that product. But comments received by FDA showed that the letter system was often confusing because it was overly simplistic, and did not reflect the available information. This system could lead to false assumptions about medications based on their category.

The revised labeling will replace the old five-letter system with more helpful information about a medication’s risks to the expectant mother, the developing fetus and the breastfed infant. In addition, the labeling will include contact information for pregnancy exposure registries that collect and maintain data on the effects of medications used by pregnant women.

Are you pregnant and taking medicines? You are not alone. Many women need to take medicines when they are pregnant. There are about six million pregnancies in the U.S. each year, and 50% of pregnant women say that they take at least one medicine. Some women take medicines for health problems, like diabetes, morning sickness or high blood pressure that can start or get worse when a woman is pregnant. Others take medicines before they realize they are pregnant.

Pregnancy can be an exciting time. However, this time can also make you feel uneasy if you are not sure how your medicines will affect your baby. Not all medicines are safe to take when you are pregnant. Even headache or pain medicine may not be safe during certain times in your pregnancy.

Here are tips to help you learn more about how prescription and over-the-counter medicines might affect you and your baby.

1. Ask Questions.

Always talk to your healthcare provider before you take any medicines, herbs, or vitamins. Don't stop taking your medicines until your healthcare provider says that it is OK.

Use these questions to help you talk to your doctor, nurse, or pharmacist:

• Will I need to change my medicines if I want to get pregnant?Before you get pregnant, work with your healthcare provider to make a plan to help you safely use your medicines.
• How might this medicine affect my baby? Ask about the benefits and risks for you and your baby.
• What medicines and herbs should I avoid? Some drugs can harm your baby during different stages of your pregnancy. At these times, your healthcare provider may have you take something else.
• Will I need to take more or less of my medicine? Your heart and kidneys work harder when you are pregnant. This makes medicines pass through your body faster than usual.
• Can I keep taking this medicine when I start breastfeeding? Some drugs can get into your breast milk and affect your baby.
• What kind of vitamins should I take? Ask about special vitamins for pregnant women called pre-natal vitamins.

Pre-Natal Vitamins

Some dietary supplements may have too much or too little of the vitamins that you need. Talk to your healthcare provider about what kind of pre-natal vitamins you should take.

What is folic acid? Folic acid helps to prevent birth defects of the baby’s brain or spine. Ask about how much folic acid you should take before you become pregnant and through the first part of your pregnancy.

2. Read the Label

Check the drug label and other information you get with your medicine to learn about the possible risks for women who are pregnant or breastfeeding. The labeling tells you what is known about how the drugs might affect pregnant women. Your healthcare provider can help you decide if you should take the medicine.

New Prescription Drug Information

The prescription drug labels are changing. The new labels will replace the old A, B, C, D and X categories with more helpful information about a medicine's risks. The labels will also have more information on whether the medicine gets into breast milk and how it can possibly affect the baby.

3. Be Smart Online

Ask your doctor, nurse, or pharmacist about the information you get online. Some websites say that drugs are safe to take during pregnancy, but you should check with your healthcare provider first. Every woman's body is different. It may not be safe for you.

• Do not trust that a product is safe just because it says 'natural'.
• Check with your healthcare provider before you use a product that you heard about in a chat room or group.

4. Report Problems.

First, tell your healthcare provider about any problems you have with your medicine. Also, tell FDA about any serious problems you have after taking a medicine.

• Call 1-800-FDA-1088 to get a reporting form sent to you by mail.
• Report problems online.

What to Report to FDA

You should report problems like serious side effects, product quality problems and product use errors. Report problems with these products:

• human drugs
• medical devices
• blood products and other biologics (except vaccines)
• medical foods

Sign Up for a Pregnancy Registry

Pregnancy Exposure Registries are research studies that get information from women who take prescription medicines or vaccines during pregnancy. Pregnancy registries help women and their doctors learn more about how medicines can be safely used during pregnancy.

• Help other pregnant women. Share your experiences with medicines.
• You will not be asked to take any new medicines.
• You will provide information about your health and your baby's health.