Not all medicines are safe to take when you are pregnant. Some medicines can harm your baby. That includes over-the-counter or prescription drugs, herbs, and supplements.

Always speak with your health care provider before you start or stop any medicine. Not using medicine that you need may be more harmful to you and your baby than using the medicine. For example, many pregnant women take prescription medicines for health problems like diabetes, asthma, seizures, and heartburn. The decision about whether or not to take a medicine depends on the risks and benefits. You and your health care provider should make this choice together.

Pregnant women should not take regular vitamins. They may have too much or too little of the vitamins that you need. There are special vitamins for pregnant women. It is important to take 0.4 mg of folic acid every day before you become pregnant through the first part of your pregnancy. Folic acid helps to prevent birth defects of the baby's brain or spine.

Are you pregnant or thinking of getting pregnant? Talk to your healthcare providers before starting or stopping any medicines. Be sure to discuss the following with your healthcare providers:

1. All medicines you take, including prescriptions, over-the-counter medicines, herbal and dietary supplements, and vitamins
2. Best ways to keep any health conditions you have under control
3. Your personal goals and preferences for the health of you and your baby

What We Know About Medicine Use in Pregnancy

Almost every pregnant woman will face a decision about taking medicines before and during pregnancy. However, we know little about the effects of taking most medicines in pregnancy because pregnant women are often not included in studies that determine the safety of new medicines. We do know

• 9 in 10 women report taking some type of medicine during pregnancy, and 7 in 10 report taking at least one prescription medicine. Over the last 30 years, women’s use of prescription medicines during the first trimester (first 3 months) of pregnancy increased by more than 60%;
• Many women need to take medicines during pregnancy to control their health conditions. In some cases, avoiding or stopping a medicine during pregnancy may be more harmful than taking that medicine;
• At the same time, we know that taking certain medicines during pregnancy can increase the risk for birth defects, pregnancy loss, prematurity, infant death, or developmental disabilities; and
• The effects of medicine on you and your baby may depend on many factors, such as
  • How much medicine you take (sometimes called the dose),
  • When during the pregnancy you take the medicine,
  • Other health conditions you have, and
  • Other medicines you take.

Have a Healthy Pregnancy

Is it safe for me to take medicines before I get pregnant?

If you are trying to have a baby or are just thinking about it, it is not too early to start getting ready for pregnancy. Many women need to take medicine to stay healthy during pregnancy. If you are planning to become pregnant, you should discuss your current medicines with a healthcare provider, such as your doctor or pharmacist. Some medicines can cause birth defects very early in pregnancy, often before you even know you are pregnant. Creating a treatment plan for your health condition before you are pregnant can help keep you and your developing baby healthy.

I need to take a medicine while pregnant. What do I do?

If you are pregnant, talk with a healthcare professional about any medicines you have taken or are thinking of taking. You should go over all prescriptions, over-the-counter medicines, herbal and dietary supplements, and vitamins. Although no medicine is completely risk-free, a healthcare professional, such as a doctor or pharmacist, can help you pick a treatment plan that works for you. You should not start any new medicines or stop a current medicine without talking to a healthcare professional.

You might need to take medicines to treat a health condition. For example, if you have asthma, epilepsy, high blood pressure, or depression, you may need to take medicines to stay healthy during pregnancy. Some untreated health conditions may actually be more harmful than the medicines used to control them. However, we know that some medicines can increase the risk of birth defects, pregnancy loss, prematurity, infant death, or developmental disabilities. A healthcare professional can help you weigh the risks and benefits of each medicine and determine the safest treatment for you and your developing baby.

I took a medicine before I knew I was pregnant. What do I do?

If you took medicines before you learned you were pregnant, you may want to talk with a healthcare professional about any concerns you may have. Some medicines can be harmful when taken during pregnancy, but others are unlikely to cause harm. If you are concerned and cannot reach your doctor, you can contact an expert for free through email, text, call, or live chat on the MotherToBaby website.

Should I trust online information about medicine safety in pregnancy?

Use caution when consulting online sources about medicine safety in pregnancy– instead, use this information to start a conversation with a healthcare professional. Many websites post lists of medicines that are “safe” to take during pregnancy. However, for many medicines listed, there is not enough scientific evidence of their safety during pregnancy.

Take caution when watching online videos as well. A 2015 study found that content in current YouTube videos does not accurately describe the safety of specific medicines used during pregnancy. This is an important reason for you to talk with a healthcare professional about potential risks of using medicines during pregnancy.

Can I take medicine once I’m no longer pregnant?

After pregnancy, keep you and your baby healthy by talking with a healthcare professional, such as a doctor or pharmacist, about the medicines you are thinking of taking. LactMede is an online database that provides information about specific medicines, ways they might affect you or your baby, and potential alternatives to consider. Information in this database can help guide the conversation with your healthcare professional about managing your health condition while breastfeeding.

How You Can Help

We know little about the effects of taking most medicines in pregnancy, because pregnant women are often not included in studies that determine the safety of new medicines. As a result, women and healthcare professionals have limited information about the safety of most medicines — especially newer medicines— in pregnancy.

Treating for Two and its partners are gathering new information on medicines taken during pregnancy and how medicines might affect the pregnancy.

You can help improve the evidence on medicines and pregnancy by doing the following:

• Report suspected problems. First, tell your healthcare provider about any problems you have with your medicine. You can also report suspected problems with medicines directly to the Food and Drug Administration (FDA) MedWatch Program.
• Enroll in a pregnancy registry. Pregnancy registries are systems for tracking outcomes in pregnant women who take a particular medicine. After these women give birth, researchers compare the health of their babies with the babies of women who did not take the medicine. Pregnancy registries are a useful way to study the effects of a particular medicine and gather health information during pregnancy and after delivery. For a list of current pregnancy registries and how to enroll, visit the FDA Pregnancy Registry website.
• Sign up for a research study. Help researchers find answers about the safety of medicines during pregnancy by signing up for a MotherToBaby Pregnancy Study. If you choose to join a study, you will not be asked to take any medicines or vaccines or change any part of your routine. To see if you are eligible, visit the MotherToBaby website or call (877) 311-8972 (Toll-Free).

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.

The journal Birth Defects Research (Part A) has published a study looking at the relationship between reported antibiotic use among women with kidney, bladder, or just urinary tract infections (all referred to as UTIs) just before or during the first trimester of pregnancy and birth defects. The findings showed that women who used the antibiotics trimethoprim-sulfamethoxazole, nitrofurantoin, or cephalosporins were at higher risk for one or more major birth defects, as compared to women who only took penicillin.

Untreated UTIs can cause serious problems for the mother and baby during pregnancy. Therefore, women should consult their doctors and seek treatment if they suspect they might have a UTI. Despite these study findings, it is important to remember that individual birth defects are rare, and women and their doctors should work together to make any treatment decisions.

Main Findings

• About one in 13 women reported having a doctor-diagnosed, fever-free UTI just before or during pregnancy.
• Among women with a UTI, a majority of them reported taking an antibiotic medication.

Asthma, a disease that affects the lungs, is a common disease during pregnancy, affecting about 4%–12% of pregnant women. About 3% of pregnant women use asthma medications, including bronchodilators or anti-inflammatory drugs. Currently, guidelines recommend that women with asthma continue to use medication to control their condition during pregnancy. However, the safety data on using asthma medications during pregnancy are limited.

Recently, researchers used data from the National Birth Defects Prevention Study (NBDPS) to examine maternal asthma medication use during pregnancy and the risk of certain birth defects.

Main Findings

• Data from the study showed that using asthma medication during pregnancy
  • Did not increase the risk for most of the birth defects studied.
  • Might increase the risk for some birth defects, such as esophageal atresia (birth defect of the esophagus or food tube), anorectal atresia (birth defect of the anus), and omphalocele (birth defect of the abdominal wall).
• The most commonly reported asthma medications used during pregnancy were
  • Albuterol (2%–3% of women)
  • Fluticasone (About 1% of women)
• It was difficult to determine if asthma or other health problems related to having asthma increased the risk for these birth defects, or if the increased risk was from the medication use during pregnancy.

Please Remember

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.

A study from the Slone Epidemiology Center at Boston University, in collaboration with the Centers for Disease Control and Prevention (CDC), found that taking ondansetron during early pregnancy did not appear to increase the chance of having a baby with a birth defect. Ondansetron (Zofran®) is a medicine used to treat nausea and vomiting that may be caused by surgery, chemotherapy, or radiation therapy. Healthcare professionals also prescribe ondansetron during pregnancy to reduce symptoms of nausea and vomiting, also known as “morning sickness.”

Main Findings

• In this study:
  • About 7 in 10 mothers reported “morning sickness” during the first three months of pregnancy.
  • Use of ondansetron by pregnant women increased from about 1 in 100 before 2000 to about 1 in 10 by 2011.

• For most of the birth defects studied, researchers found that taking ondansetron during early pregnancy did not appear to increase the chance of having a baby with a birth defect.
• Women should discuss options for managing nausea and vomiting symptoms during pregnancy with their healthcare providers.

About This Study

• Researchers used data from the Slone Epidemiology Center Birth Defects Study and the National Birth Defects Prevention Study, which collect information on pregnancies affected by birth defects and babies born without birth defects in order to study what might cause or prevent birth defects.

About Birth Defects

Birth defects are common, costly, and critical conditions that affect 1 in every 33 babies born in the United States. Birth defects are structural changes present at birth that can affect almost any part or parts of the body (such as the heart, brain, face, arms, and legs). They may affect how the body looks, works, or both.

The American Journal of Obstetrics and Gynecology has published a new CDC study: “Maternal Treatment with Opioid Analgesics and Risk for Birth Defects”. The findings from this article are summarized in the following text.

Main Findings from this Study

• Treatment with opioid analgesics was linked with the following birth defects:
  • Spina bifida (a type of neural tube defect)
  • Hydrocephaly (build up of fluid in the brain)
  • Glaucoma (an eye defect)
  • Gastroschisis (a defect of the abdominal wall)
  • Congenital heart defects
    • Conoventricular septal defect
    • Atrioventricular septal defect
    • Hypoplastic left heart syndrome
    • Atrial septal defect
    • Tetralogy of Fallot
    • Pulmonary valve stenosis
• Treatment with opioid analgesics just before or during early pregnancy was reported by 2% to 3% of the mothers.
• Codeine and hydrocodone were the most frequently reported medications, representing 69% of all reported opioid analgesics used.
• Commonly reported reasons for treatment with opioid analgesics during pregnancy included surgical procedures, infections, chronic diseases, and injuries.

Treatment Decisions

When making treatment decisions just before or during pregnancy, it is important that women and their doctors weigh the benefits of opioid analgesic medications along with their potential risks for birth defects, including some types of congenital heart defects, which are important contributors to infant morbidity and mortality.

The findings related to congenital heart defects were consistent with findings of previous studies showing links between the use of codeine during the first trimester and the occurrence of some heart defects. Congenital heart defects are among the most common birth defects, affecting nearly 1% of U.S. births, and are the main contributor to infant death attributable to birth defects. As mentioned earlier, previous studies have suggested that treatment with opioid analgesics might increase the risk for cleft lip and palate. However, in this study, the occurrence of cleft lip and palate did not appear to be linked with treatment with opioid analgesics.

In this study, the findings related to some of the other birth defects were observed for the first time. For example, links between the use of opioid analgesics and the occurrence of hydrocephaly, glaucoma, or gastroschisis have not been observed in previous studies and deserve further investigation.

About Opioid Analgesics and this Study

Opioid analgesics are prescription medications that commonly are used to treat severe pain. Two common opioid medications are codeine and oxycodone. Lower doses of opioids also might be included in some cough medicines. The effects of opioids on a pregnant woman and her unborn baby are not well understood. Previous studies looking at opioid analgesics and birth defects have had inconsistent findings. However, some have suggested that these medications might increase the risk for heart defects or cleft lip and palate.

For this study, researchers aimed to see if treatment with any opioid analgesic medication just before or during early pregnancy was associated with the occurrence of certain birth defects. The study used data from the National Birth Defects Prevention Study, a population-based, case-control study to understand the causes of and risk factors for major birth defects in the United States. Population-based means that the study looked at all babies with birth defects whose mothers lived in the study region, which is important to make sure that study results apply to the U.S. population in general.

The American Journal of Obstetrics and Gynecology has published a new study: “Use of topiramate in pregnancy and risk of oral clefts.”

Main Finding from this Study

Use of topiramate during the first trimester of pregnancy was associated with an increased risk of oral clefts (i.e., cleft lip with or without cleft palate) in the offspring.

About this Study

• What is topiramate?
  Topiramate is a medication used to treat epilepsy. It is also considered for treatment of sleep and eating disorders, migraines, other psychiatric conditions, and weight loss. Topiramate is also a component of Qsymia, a medicine which was approved by the Food and Drug Administration (FDA) on 7/17/2012 for chronic weight management. For more information on this weight loss medicine, please see the FDA press release here.Topiramate is currently considered a Category D medication by the FDA. This means that potential risks of using the medicine during pregnancy have been recognized, but benefits of the medicine may warrant use despite the risks.
• What were the study results?
  This study looked at the risk of oral clefts in infants whose mothers took topiramate during the first trimester of pregnancy. It used data from two large birth defects case-control studies (Slone Epidemiology Center Birth Defects Study and National Birth Defects Prevention Study). Both studies showed an increased risk of oral clefts in infants exposed to topiramate during the first trimester compared to infants not exposed to antiepileptic medicines.
• What is currently known on this subject?
  Previous studies have shown a potential association between oral clefts and the use of topiramate during pregnancy. However, this association has been hard to evaluate because both the use of topiramate during pregnancy and the occurrence of oral clefts are rare.
• What does this study add?
  This study supports previous findings showing an increased risk of oral clefts among infants exposed to topiramate. Assuming this study is correct, this means that for any pregnancy exposed to topiramate, the risk of oral clefts in the offspring would be increased 5-fold. However, because oral clefts are a rare occurrence, it is important to keep the absolute risks in mind. Approximately 1 in 1,000 infants is born with cleft lip with or without cleft palate in the US each year, and for any topiramate-exposed pregnancy, the risk would increase to approximately 5 in 1,000 infants.

Please Remember

When making treatment decisions just before or during pregnancy, it is important that women and their doctors weigh the benefits of medications, such as topiramate, along with their potential risks for birth defects.

Fetal minoxidil syndrome is a group of symptoms that may be found in a newborn when a mother has taken minoxidil (Loniten) during pregnancy. Minoxidil is a medication that can be used to treat hypertension (increased blood pressure) and alopecia (hair loss). A few cases of maternal use of minoxidil have been published in the medical literature with findings of neonatal (newborn) hypertrichosis (excessive hair growth) that gradually resolves during the first six months of life. Other symptoms have been reported, such as congenital heart defects; neurodevelopmental anomalies; and gastrointestinal, kidney, and limb malformations. More studies are needed to determine the potential risks to the fetus during pregnancy.

Fetal hydantoin syndrome is a disorder that is caused by exposure of a fetus to phenytoin, a drug commonly prescribed for epilepsy. Not all infants exposed to phenytoin will be affected with the disorder. Symptoms in affected individuals may include abnormalities of the skull and facial features, growth deficiencies, underdeveloped nails of the fingers and toes, and/or mild developmental delays. Other findings occasionally associated with this syndrome include cleft lip and palate, having an abnormally small head (microcephaly) and brain malformations with more significant developmental delays.

Treatment may include surgery for cleft lip and palate and special education and related services for children with learning delays. Other treatment is symptomatic and supportive.

Taking an oral corticosteroid like prednisone long-term during pregnancy has been associated with an increased chance for delivering a baby that is premature (born before 37 weeks of pregnancy) and/or has a lower birth weight than expected.

Older studies have suggested a small increased chance of oral clefts when oral corticosteroids like prednisone are used in the first trimester. However, a number of other studies have not shown an increase in the chance for birth defects (including oral clefts) with first trimester exposure. If there is a risk from first trimester exposure to prednisone, it is thought to be very small.

There have also been concerns that some of the toxicity associated with glucocorticoids in adults might affect exposed fetuses. However, long-term follow-up of children of mothers who received prednisone as an immunosuppressant during pregnancy did not identify adverse physical, immunologic, or neurodevelopmental effects of exposure. A follow-up study in pre-pubertal children of mothers receiving prednisone during pregnancy found higher daytime cortisol concentrations in the children, but no associated adverse effects. To our knowledge, no effects on fertility in humans has been reported.

Women who are pregnant, or planning to become pregnant, should speak with their healthcare provider about their treatment plan. In many cases, the decision to begin or continue a medication during pregnancy is made on a case-by-case basis, after careful consideration of the benefits and risks.

Fetal retinoid syndrome is a characteristic pattern of physical birth defects in a baby that has been exposed to retinoids during pregnancy. The best-known retinoid is isotretinoin (Accutane), a drug used to treat severe cystic acne.

Babies exposed to retinoids during pregnancy may have a wide variety of symptoms. Some may have no symptoms at all, others may have only intellectual and learning problems, while others will have very severe symptoms.

Birth defects associated with retinoid exposure include:

• Growth delay
• Excess fluid around the brain (hydrocephalus)
• Abnormally small head size (microcephaly)
• Intellectual and learning disabilities
• Ear and eye abnormalities
• A split in the roof of the mouth (cleft palate) and other facial differences
• Heart defects.

It is thought that 20-35% of fetuses exposed to retinoids during pregnancy will develop some of these birth defects.

Retinoids can cause these birth defects in the early weeks of pregnancy, even before a woman knows that she is pregnant. Some of the birth defects associated with fetal retinoid syndrome may be diagnosed by ultrasound during pregnancy.

No treatment exists for fetal retinoid syndrome. Babies born with this condition are treated based on their symptoms. Currently, public health programs exist to help reduce the chance that a woman will use retinoids if she is considering getting pregnant.

Fetal valproate syndrome (FVS) may occur if a developing baby is exposed to valproic acid during pregnancy. Valproic acid, also known as valproate, is a medication that is often used to treat epilepsy, bipolar disorder, and migraines. Many babies who are exposed to this medication during pregnancy are born healthy with normal growth and development. However, studies have found that women who take valproate during pregnancy have a greater chance of having a baby with a major birth defect or other health problem. Symptoms of FVS vary but may include characteristic facial features, spina bifida, congenital heart defects, cleft lip and/or cleft palate, genital abnormalities, skeletal abnormalities, and developmental delay. A child exposed to valproic acid may be at a higher risk for learning and behavioral problems. Although there is no cure for FVS, many of the possible signs and symptoms of FVS do have treatments or therapies available. Early intervention programs may also be helpful.

The U.S. Food and Drug Administration (FDA) advises that valproate and related products should not be taken by women for the prevention of migraine headaches during pregancy. With regard to valproate use in pregnant women with epilepsy or bipolar disorder, valproate products should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable. However, it is important to note that women who are pregnant and taking a valproate medication should not stop their medication but should talk to their doctor or other trusted medical professional immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby. For example, the sudden discontinuation of valproate in pregnant women with seizures can result in persistent seizures, which can cause harm, including death, to the mother and/or the unborn baby.

The FDA suggests a pregnant woman taking valproate or other anti-seizure medication should talk to her doctor or other trusted medical professional about registering with the North American Antiepileptic Drug Pregnancy Registry. The purpose of this registry is to collect information about the safety of anti-seizure medications during pregnancy. A pregnant woman taking anti-seizure medication can enroll in this registry by calling 1-888-233-2334.

When deciding whether or not to use a medicine in pregnancy, you and your doctor need to talk about the medicine's benefits and risks. Before you start or stop any medicine while you are pregnant, it is always best to speak with your doctor. Read on to learn about deciding to use medicine while pregnant.

Is it safe to use medicine while I am pregnant?

There is no clear-cut answer to this question. Before you start or stop any medicine, it is always best to speak with the doctor who is caring for you while you are pregnant. Read on to learn about deciding to use medicine while pregnant.

How should I decide whether to use a medicine while I am pregnant?

When deciding whether or not to use a medicine in pregnancy, you and your doctor need to talk about the medicine's benefits and risks.

• Benefits: what are the good things the medicine can do for me and my growing baby (fetus)?
• Risks: what are the ways the medicine might harm me or my growing baby (fetus)?

There may be times during pregnancy when using medicine is a choice. Some of the medicine choices you and your doctor make while you are pregnant may differ from the choices you make when you are not pregnant. For example, if you get a cold, you may decide to "live with" your stuffy nose instead of using the "stuffy nose" medicine you use when you are not pregnant.

Other times, using medicine is not a choice — it is needed. Some women need to use medicines while they are pregnant. Sometimes, women need medicine for a few days or a couple of weeks to treat a problem like a bladder infection or strep throat. Other women need to use medicine every day to control long-term health problems like asthma, diabetes, depression, or seizures. Also, some women have a pregnancy problem that needs treatment with medicine. These problems might include severe nausea and vomiting, earlier pregnancy losses, or preterm labor.

Where do doctors and nurses find out about using medicines during pregnancy?

Doctors and nurses get information from medicine labels and packages, textbooks, and research journals. They also share knowledge with other doctors and nurses and talk to the people who make and sell medicines.

The Food and Drug Administration (FDA) is the part of our country's government that controls the medicines that can and can't be sold in the United States. The FDA lets a company sell a medicine in the United States if it is safe to use and works for a certain health problem. Companies that make medicines usually have to show FDA doctors and scientists whether birth defects or other problems occur in baby animals when the medicine is given to pregnant animals. Most of the time, drugs are not studied in pregnant women.

The FDA works with the drug companies to make clear and complete medicine labels. But in most cases, there is not much information about how a medicine affects pregnant women and their growing babies. Many prescription medicine labels include the results of studies done in pregnant animals. But a medicine does not always affect growing humans and animals in the same way. Here is an example:

A medicine is given to pregnant rats. If the medicine causes problems in some of the rat babies, it may or may not cause problems in human babies. If there are no problems in the rat babies, it does not prove that the medicine will not cause problems in human babies.

The FDA asks for studies in two different kinds of animals. This improves the chance that the studies can predict what may happen in pregnant women and their babies.

There is a lot that FDA doctors and scientists do not know about using medicine during pregnancy. In a perfect world, every medicine label would include helpful information about the medicine's effects on pregnant women and their growing babies. Unfortunately, this is not the case.

How do prescription and over-the-counter (OTC) medicine labels help my doctor choose the right medicine for me when I am pregnant?

Doctors use information from many sources when they choose medicine for a patient, including medicine labels. To help doctors, the FDA created pregnancy letter categories to help explain what is known about using medicine during pregnancy. This system assigns letter categories to all prescription medicines. The letter category is listed in the label of a prescription medicine. The label states whether studies were done in pregnant women or pregnant animals and if so, what happened. Over-the-counter (OTC) medicines do not have a pregnancy letter category. Some OTC medicines were prescription medicines first and used to have a letter category. Talk to your doctor and follow the instructions on the label before taking OTC medicines.

Prescription medicines

The FDA chooses a medicine's letter category based on what is known about the medicine when used in pregnant women and animals.

The FDA is working hard to gather more knowledge about using medicine during pregnancy. The FDA is also trying to make medicine labels more helpful to doctors. Medicine label information for prescription medicines is now changing, and the pregnancy part of the label will change over the next few years. As this prescription information is updated, it is added to an online information clearinghouse called DailyMed that gives up-to-date, free information to consumers and health care providers.

OTC medicines

All OTC medicines have a drug facts label. The Drug Facts label is arranged the same way on all OTC medicines. This makes information about using the medicine easier to find. One section of the Drug Facts label is for pregnant women. With OTC medicines, the label usually tells a pregnant woman to speak with her doctor before using the medicine. Some OTC medicines are known to cause certain problems in pregnancy. The labels for these medicines give pregnant women facts about why and when they should not use the medicine. Here are some examples:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Advil, Motrin), naproxen (Aleve), and aspirin (acetylsalicylate), can cause serious blood flow problems in the baby if used during the last 3 months of pregnancy (after 28 weeks). Also, aspirin may increase the chance for bleeding problems in the mother and the baby during pregnancy or at delivery.
• The labels for nicotine therapy drugs, like the nicotine patch and lozenge, remind women that smoking can harm an unborn child. While the medicine is thought to be safer than smoking, the risks of the medicine are not fully known. Pregnant smokers are told to try quitting without the medicine first.

What if I'm thinking about getting pregnant?

If you are not pregnant yet, you can help your chances for having a healthy baby by planning ahead. Schedule a pre-pregnancy checkup. At this visit, you can talk to your doctor about the medicines, vitamins, and herbs you use. It is very important that you keep treating your health problems while you are pregnant. Your doctor can tell you if you need to switch your medicine. Ask about vitamins for women who are trying to get pregnant. All women who can get pregnant should take a daily vitamin with folic acid (a B vitamin) to prevent birth defects of the brain and spinal cord. You should begin taking these vitamins before you become pregnant or if you could become pregnant. It is also a good idea to discuss caffeine, alcohol, and smoking with your doctor at this time.

Is it safe to use medicine while I am trying to become pregnant?

It is hard to know exactly when you will get pregnant. Once you do get pregnant, you may not know you are pregnant for 10 to 14 days or longer. Before you start trying to get pregnant, it is wise to schedule a meeting with your doctor to discuss medicines that you use daily or every now and then. Sometimes, medicines should be changed, and sometimes they can be stopped before a woman gets pregnant. Each woman is different. So you should discuss your medicines with your doctor rather than making medicine changes on your own.

If you are pregnant or thinking about getting pregnant:

• Do not stop any prescribed medicines without first talking to your doctor.
• Talk to your doctor before using any over-the-counter medicine.

What if I get sick and need to use medicine while I am pregnant?

Whether or not you should use medicine during pregnancy is a serious question to discuss with your doctor. Some health problems need treatment. Not using a medicine that you need could harm you and your baby. For example, a urinary tract infection (UTI) that is not treated may become a kidney infection. Kidney infections can cause preterm labor and low birth weight. You need an antibiotic to cure a UTI. Ask your doctor whether the benefits of taking a certain medicine outweigh the risks for you and your baby.

I have a health problem. Should I stop using my medicine while I am pregnant?

If you are pregnant or thinking about becoming pregnant, you should talk to your doctor about your medicines. Do not stop or change them on your own. This includes medicines for depression, asthma, diabetes, seizures (epilepsy), and other health problems. Not using medicine that you need may be more harmful to you and your baby than using the medicine.

For women living with HIV, the Centers for Disease Control and Prevention (CDC) recommends using zidovudine (AZT) during pregnancy. Studies show that HIV positive women who use AZT during pregnancy greatly lower the risk of passing HIV to their babies. If a diabetic woman does not use her medicine during pregnancy, she raises her risk for miscarriage, stillbirth, and some birth defects. If asthma and high blood pressure are not controlled during pregnancy, problems with the fetus may result.

Are vitamins safe for me while I am pregnant?

Women who are pregnant should not take regular vitamins. They can contain doses that are too high. Ask about special vitamins for pregnant women that can help keep you and your baby healthy. These prenatal vitamins should contain at least 400 - 800 micrograms (µg) of folic acid. It is best to start taking these vitamins before you become pregnant or if you could become pregnant. Folic acid reduces the chance of a baby having a neural tube defect, like spina bifida, where the spine or brain does not form the right way. See our information on folic acid. Iron can help prevent a low red blood cell count (anemia). It's important to take the vitamin dose prescribed by your doctor. Too many vitamins can harm your baby. For example, very high levels of vitamin A have been linked with severe birth defects.

Are herbs, minerals, or amino acids safe for me while I am pregnant?

No one is sure if these are safe for pregnant women, so it's best not to use them. Even some "natural" products may not be good for women who are pregnant or breastfeeding. Except for some vitamins, little is known about using dietary supplements while pregnant. Some herbal remedy labels claim that they will help with pregnancy. But, most often there are no good studies to show if these claims are true or if the herb can cause harm to you or your baby. Talk with your doctor before using any herbal product or dietary supplement. These products may contain things that could harm you or your growing baby during your pregnancy.

In the United States, there are different laws for medicines and for dietary supplements. The part of the FDA that controls dietary supplements is the same part that controls foods sold in the United States. Only dietary supplements containing new dietary ingredients that were not marketed before October 15, 1994 submit safety information for review by the FDA. However, unlike medicines, the FDA does not approve herbal remedies and "natural products" for safety or for what they say they will do. Most have not even been evaluated for their potential to cause harm to you or the growing fetus, let alone shown to be safe for use in pregnancy. Before a company can sell a medicine, the company must complete many studies and send the results to the FDA. Many scientists and doctors at the FDA check the study results. The FDA allows the medicine to be sold only if the studies show that the medicine works and is safe to use.

Are vaccines safe for me while I am pregnant?

Vaccines protect your body against dangerous diseases. Some vaccines are not safe to receive during pregnancy. For some vaccines, the decision to use it during pregnancy depends on the woman's own situation. Her doctor may consider these questions before giving a vaccine:

1. Is there a high chance she will be exposed to the disease?
2. Would the infection pose a risk to the mother or fetus?
3. Is the vaccine unlikely to cause harm?

The Advisory Committee on Immunization Practices recommends that Hepatitis B vaccination should be considered when women are at risk for developing Hepatitis B during pregnancy, and inactivated influenza vaccine should be considered for women who are pregnant during flu season. On the other hand, a pregnant woman who is not immune to rubella (German measles) is not given a rubella vaccine until after pregnancy. Talk with your doctor to make sure you are fully protected. The Centers for Disease Control and Prevention (CDC) provides vaccine guidelines for pregnant women.

In the future, will there be better ways to know if medicines are safe to use during pregnancy?

At this time, drugs are rarely tested for safety in pregnant women for fear of harming the unborn baby. Until this changes, pregnancy exposure registries help doctors and researchers learn how medicines affect pregnant mothers and their growing babies. A pregnancy exposure registry is a study that enrolls pregnant women who are using a certain medicine. The women sign up for the study while pregnant and are followed for a certain length of time after the baby is born. Researchers compare babies of mothers who used the medicine while pregnant to babies of mothers who did not use the medicine. This type of study compares large groups of pregnant mothers and babies to look for medicine effects. A woman and her doctor can use registry results to make more informed choices about using medicine while pregnant.

If you are pregnant and are using a medicine or were using one when you got pregnant, check to see if there is a pregnancy exposure registry for that medicine. The Food and Drug Administration has a list of pregnancy exposure registries that pregnant women can join.