Posts Tagged ‘medications during pregnancy’

Pregnancy Exposure Registries Help Moms-To-Be Share Their Experiences with Medicines

Monday, January 29th, 2018

Are you pregnant and taking medicines? FDA encourages women like you to participate in pregnancy exposure registry studies that track the outcomes of pregnancies in which medicines were taken during pregnancy.

We are joined today by Dr. Marjorie Jenkins, Director of Scientific Engagement and Medical Initiatives for FDA’s Office of Women’s Health. Dr Jenkins joined the FDA Office of Women’s Health (OWH) in 2015. In her role as OWH Director of Medical Initiatives and Scientific Engagement, Dr. Jenkins provides sex and gender-specific women’s health scientific expertise within research, health education, and communications initiatives.  Dr. Jenkins will tell us why pregnancy exposure registries are so important.

What are pregnancy exposure registries?

A pregnancy exposure registry is a study that collects health information from women who take prescription medicines or vaccines when they are pregnant. The study also collects information on the health of the newborn baby. This information is compared with women who have not taken medicine during pregnancy. The information is used to learn more about the effects of medicines and vaccines taken during pregnancy.

Why are pregnancy exposure registries important?

About half of all pregnant women report taking at least one medication during pregnancy. Many women have health problems like high blood pressure, arthritis or epilepsy, and they need to continue to take prescription medicine when they are pregnant. Other women take medicine before they realize they are pregnant.

Pregnancy exposure registries are one way that we can learn more about the safety of medicines and vaccines.

By enrolling in a pregnancy exposure registry, you can help other pregnant women and doctors find out more about medicines’ and vaccines’ safety in pregnancy. The safety information collected in the registry may be used to update medical product labeling.

Does FDA conduct pregnancy exposure registries?

No. FDA does not run the pregnancy exposure registry studies. The drug company that makes the medicine/vaccine or a research institution is usually in charge of the pregnancy exposure registry.

FDA keeps a list of ongoing registries on the FDA Pregnancy Registry website. The website may not represent a comprehensive list of all available pregnancy exposure registries. FDA does not endorse any registry and is not responsible for the content of registries listed.

Where can a pregnant woman find more information about a registry and how to participate?

It is a requirement that prescription medicine and vaccine labeling include information about the existence of a pregnancy registry. The Pregnancy subsection includes the contact information for the pregnancy exposure registry.

The FDA Office of Women’s Health created a website to help connect pregnant women and health professionals to pregnancy registries. The website includes a list of registries with the contact information that you can use to sign up for each registry.

There are instructions on the website to help you find out if there is a registry for your medicine or vaccine. You can search for a registry using the name of the medicine or vaccine or your medical condition.

What happens when you sign up for a registry?

Each registry has its own procedures about how they contact you and what you need to do to participate. The registry may contact you a few times during pregnancy and after you have had your baby to ask questions about you and your baby’s health. The calls can be as short as 10-15 minutes.

You will not be asked to take any new medicines to participate in the registry. The pregnancy exposure registry is only interested in medicines that you are already taking.

Thank you for the opportunity to talk about pregnancy exposure registries. I hope that you will visit www.fda.gov/pregnancyregistries to learn more about how you can sign up to share your experiences.

“Spread Prevention, Not the Infection” during Pregnancy: Syphilis

Thursday, January 25th, 2018

This year the theme of  National Birth Defects Prevention Month is Prevent to Protect. This week we will be posting a series of guest posts from MotherToBaby’s Kirstie Perrotta, MPH, Lorrie Harris-Sagaribay, MPH, Robert Felix and Susan Sherman of the Organization of Teratology Information Specialists (OTIS) Zika Task Force. Each day they will respond to one of the top five questions they receive about preventable infectious diseases and what you can do to prevent exposure during pregnancy.

“It’s 2018! I didn’t even know you could get syphilis nowadays!” Yes, I mentioned the stats about syphilis and other infections that can affect pregnancy to the caller who had contacted me through our free MotherToBaby helpline. I thought, this is a great time to educate her as well as others about a variety of infections. Some infections, like Zika, seem to make headlines every week, while others tend to be discussed much less frequently. January is National Birth Defects Prevention Month, and this year’s focus is on infection prevention.

I just found out I have syphilis and my doctor recommended medication to treat it, but I’m worried the medication will hurt the baby. What should I do?

Syphilis is a sexually transmitted infection (STI) caused by bacteria that can be treated and cured with antibiotics. Learning that you have syphilis when you are pregnant is frightening, but the earlier you treat the infection, the better the outcome for you and your baby.

The syphilis bacteria can spread to the baby during pregnancy (called congenital syphilis or CS). CS can cause stillbirth, prematurity, or other pregnancy problems, including birth defects of the bones, the brain and other body systems. If you are diagnosed with syphilis during pregnancy, be sure to talk with your baby’s pediatrician since a baby might develop symptoms of CS even after being born.

The medications that are used to treat syphilis have been around for many years and are well studied. While there is always the possibility of side effects with any medication, the antibiotics used to treat syphilis during pregnancy are very well tolerated by most women.

The MotherToBaby website contains fact sheets on many of the medications doctors prescribe during pregnancy. If you still have concerns about the medication your doctor has prescribed to treat your syphilis, you can review the fact sheet and contact a MotherToBaby specialist at 866-626-6847.

Other posts in the series:

“Spread Prevention, Not the Infection” during Pregnancy: Zika

“Spread Prevention, Not the Infection” during Pregnancy: Listeria

“Spread Prevention, Not the Infection” during Pregnancy: Toxoplasmosis

About MotherToBaby 

MotherToBabyis a service of the Organization of Teratology Information Specialists (OTIS), suggested resources by many agencies including the Centers for Disease Control and Prevention (CDC). If you have questions about exposures during pregnancy and breastfeeding, please call MotherToBaby toll-FREE at 866-626-6847 or try out MotherToBaby’s new text information service by texting questions to (855) 999-3525. You can also visit MotherToBaby.org to browse a library of fact sheets about dozens of viruses, medications, vaccines, alcohol, diseases, or other exposures during pregnancy and breastfeeding or connect with all of our resources by downloading the new MotherToBaby free app, available on Android and iOS markets.

Why is prenatal care so important?

Friday, July 14th, 2017

Doctor with pregnant woman during check-upGetting early and regular prenatal care can help you have a healthy and full-term pregnancy. However, a recent report shows that the preterm birth rate in the US has increased for the second year in a row. This is an alarming indication that the health of pregnant women and babies in our country is getting worse. As Stacey D. Stewart, president of the March of Dimes states, “Every mother needs healthcare throughout her pregnancy to help avoid preterm birth and birth complications, with the goal of every baby being born healthy.”

So, what can you do to have a healthy pregnancy and a healthy baby? You should call your health care provider to schedule your first appointment as soon as you find out you’re pregnant. Make sure you’re ready to talk to your provider about:

  • The first day of your last menstrual period (also called LMP). Your provider can use this to help find out your baby’s due date.
  • Health conditions. Such as depression, diabetes, high blood pressure, and not being at a healthy weight. Conditions like these can cause problems during pregnancy. Tell your provider about your family health history.
  • Medicines. This includes prescription medicine, over-the-counter medicine, supplements and herbal products. Some medicines can hurt your baby if you take them during pregnancy, so you may need to stop taking it or switch to another medicine. Don’t stop or start taking any medicine without talking to your provider first. And tell your provider if you’re allergic to any medicine.
  • Your pregnancy history. Tell your provider if you’ve been pregnant before or if you’ve had trouble getting pregnant. Tell her if you’ve had any pregnancy complications or if you’ve had a premature baby (a baby born before 37 weeks of pregnancy), a miscarriage or stillbirth.
  • Smoking, drinking alcohol, using street drugs and abusing prescription drugs. All of these can hurt your baby.
  • Stress. Stress is worry, strain or pressure that you feel in response to things that happen in your life. Talk to your provide about ways to deal with and reduce your stress. High levels of stress can cause complications during pregnancy.
  • Your safety at home and work. Tell your provider about chemicals you use at home or work and about what kind of job you have.

Make sure you go to all of your prenatal care appointments, even if you feel fine. Going to all of your checkups gives your provider the chance to make sure you and your baby are healthy and allows you to ask any questions you may have (write them down before your appointment so you don’t forget).

The March of Dimes work to give every baby a healthy start is more vital than ever. We urge everyone concerned about the health of babies to make their voices heard by going to marchofdimes.org.

What you need to know about birth defects

Monday, January 18th, 2016

snugglingEvery 4 ½ minutes in the US, a baby is born with a birth defect. That means that nearly 120,000 (or 1 in every 33) babies are affected by birth defects each year. They are a leading cause of death in the first year of life, causing one in every five infant deaths and they lead to $2.6 billion per year in hospital costs alone in the United States.

What are birth defects?

Birth defects are health conditions that are present at birth. They change the shape or function of one or more parts of the body and can affect any part of the body (such as the heart, brain, foot, etc). They may affect how the body looks, works, or both.

There are thousands of different birth defects and they can be very mild or very severe. Some do not require any treatment, while others may require surgery or lifelong medical interventions.

What causes birth defects?

We know what causes certain birth defects. For instance, drinking alcohol while you are pregnant can cause your baby to be born with  physical birth defects and mental impairment. And genetic conditions, such as cystic fibrosis or sickle cell disease, are the result of inheriting a mutation (change) in a single gene. However, we do not know what causes the majority of birth defects. In most cases, it is a number of complex factors. The interaction of multiple genes, personal behaviors, and our environment all may all play a role.

Can we prevent birth defects?

Most birth defects cannot be prevented. But there are some things that a woman can do before and during pregnancy to increase her chance of having a healthy baby:

  • See your healthcare provider before pregnancy and start prenatal care as soon as you think you’re pregnant.
  • Get 400 micrograms (mcg) of folic acid every day. Folic acid reduces the chance of having a baby with a neural tube defect.
  • Avoid alcohol, cigarettes, and “street” drugs.
  • Talk to your provider about any medications you are taking, including prescription and over-the-counter medications and any dietary or herbal supplements. Talk to your provider before you start or stop taking any type of medications.
  • Prevent infections during pregnancy. Wash your hands and make sure your vaccinations are up to date.
  • Make sure chronic medical conditions are under control, before pregnancy. Some conditions, like diabetes and obesity, may increase the risk for birth defects.
  • Learn about your family health history.

Have questions? Email us at AskUs@marchofdimes.org.

Depression: symptoms and treatment options

Friday, October 9th, 2015

contemplative woman faceDepression is more than just feeling sad. It is a medical condition that affects your thoughts, feelings, and even causes changes to your body. You may have depression if you have any of these signs that last for more than 2 weeks:

Changes in your feelings 

  • Feeling sad, hopeless or overwhelmed
  • Feeling restless or moody
  • Crying a lot
  • Feeling worthless or guilty

Changes in your everyday life 

  • Eating more or less than you usually do
  • Having trouble remembering things, concentrating or making decisions
  • Not being able to sleep or sleeping too much
  • Withdrawing from friends and family
  • Losing interest in things you usually like to do

Changes in your body 

  • Having no energy and feeling tired all the time
  • Having headaches, stomach problems or other aches and pains that don’t go away

If you have any of these symptoms, talk to your health care provider.

Depression during pregnancy

If you’ve had depression before, you’re more likely than other women to experience depression during pregnancy. If left untreated, depression during pregnancy can affect your baby. If you’re pregnant and have depression that’s not treated, you’re more likely to have:

  • Premature birth (before 37 weeks of pregnancy).
  • A low-birthweight baby (a baby weighing less than 5 pounds, 8 ounces).
  • A baby who is more irritable, less active, less attentive and has fewer facial expressions than babies born to moms who don’t have depression during pregnancy.

It’s best if a team of providers treats your depression during pregnancy. These providers can work together to make sure you and your baby get the best care. They may include your prenatal care provider and a professional who treats your depression (such as a psychiatrist, psychologist, therapist, or counselor).

There are several treatment options available for depression during pregnancy including talk therapy, support groups and medicine, such as antidepressants.

Some research shows that taking an antidepressant during pregnancy may put your baby at risk for certain health conditions. But if you’ve been taking an antidepressant, it may be harmful to you to stop taking it. So talk with your provider about the benefits and risks of taking an antidepressant while you’re pregnant. Together you can then decide what you want your treatment to be. If you’re taking an antidepressant and find out you’re pregnant, don’t stop taking the medicine without talking to your provider first. Not taking your medicine may be harmful to your baby, and it may make your depression come back.

If you’re pregnant and you have any signs of depression, talk to your health care provider. There are things you and your provider can do to help you feel better.

Have questions? Text or email us at Askus@marchofdimes.org.

New study looks at link between antidepressants and birth defects

Friday, July 10th, 2015

pregnant woman with MDThe use of certain antidepressants during pregnancy is associated with a higher risk of birth defects, according to a new study. But other antidepressants do not carry the same risk.

The study looked at a specific group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). SSRIs are medications used to treat depression and other mental health conditions. Previous studies gave conflicting evidence about potential links between the use of SSRIs during pregnancy and certain birth defects.

In this study, researchers from the CDC analyzed data from 17,952 mothers of infants with birth defects and 9,857 mothers of infants without birth defects, born between 1997 and 2009.

The researchers found that some birth defects occur about two or three times more frequently among babies born to women who took certain SSRI medications, like Prozac (fluoxetine) and Paxil (paroxetine) early in pregnancy. It is important to note that the actual risk for a birth defect among babies born to women taking Prozac or Paxil is still very low. For example, the risks for a specific heart defect could increase from 10 per 10,000 births to about 24 per 10,000 births among babies of women who are treated with Paxil early in pregnancy. Since these specific types of birth defects are rare, even doubling the risk still results in a low overall chance.

Researchers did not find a link between birth defects and other SSRIs such as Zoloft (sertraline).

“A pregnant woman should be reassured that she can choose a safe drug to treat her depression and not have to go off her medication because she is afraid her baby may develop a birth defect,” Dr. Edward McCabe, Chief Medical Officer of the March of Dimes said. “Not treating depression can be unhealthy for both the mom and her baby. It can cause stress, and stress during pregnancy is associated with early births and low-birthweight babies.”

If you are currently taking an antidepressant and are concerned, do not stop taking the medication until you talk to your health care provider. And if you are planning to become pregnant and are taking an antidepressant, schedule a preconception checkup and discuss what medications may be best for you.