Study Suggests Adalimumab Exposure in Pregnancy Does Not Increase Birth Defects Risk

602 Pregnancies Examined by the Non-Profit Organization of Teratology Information Specialists

LA JOLLA, CA –A new study conducted by birth defects experts from the Organization of Teratology Information Specialists (OTIS) suggests adalimumab use in pregnancy was not associated with an increased risk for adverse outcomes examined, such as major structural birth defects, spontaneous abortion and preterm delivery. The findings were published today in the Public Library of Science (PLOS) One Journal.

The prospective research study conducted by OTIS examined 602 pregnancies that occurred between 2004 – 2016 in women across the U.S. and Canada. Researchers enrolled pregnant women into the observational cohort study who had or had not taken adalimumab for their autoimmune disease, as well as generally healthy pregnant women for comparison. OTIS is the scientific non-profit society that provides the no-cost MotherToBaby information service and enrolls women through the MotherToBaby Pregnancy Studies Research Center at the University of California San Diego. Financial support for the adalimumab study was provided by AbbVie.

“Many women hoping to start a family rely on adalimumab to control symptoms related to crippling autoimmune diseases such as rheumatoid arthritis or Crohn’s Disease,” said lead study author Christina Chambers, PhD, MPH, OTIS/MotherToBaby president and professor of pediatrics at the University of California, San Diego. “The fact that this study showed no increased risk in adverse birth outcomes with the use of adalimumab in pregnancy is important since not a lot of research was previously available on this particular medication.”

The study also found that regardless of whether they took adalimumab or not, pregnant women with rheumatoid arthritis or Crohn’s Disease were at an increased risk of preterm birth (delivery before 37 weeks of pregnancy).

“Studies on medication use in general are lacking when it comes to understanding their effects on pregnancy, making it difficult for pregnant women and their healthcare providers to make informed decisions,” said Dr. Chambers. “We are proud to add valuable information to the literature and encourage more pregnant women to consider volunteering for critical observational studies.”

For more information on all of the current MotherToBaby Pregnancy Studies, please visit https://mothertobaby.org/pregnancy-studies/.

More about OTIS and MotherToBaby

The Organization of Teratology Information Specialists (OTIS) is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of: obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and includes experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies. MotherToBaby is a suggested resource by many federal agencies including the Centers for Disease Control and Prevention (CDC). To learn more about ongoing MotherToBaby Pregnancy Studies, call (877) 311-8972, email MotherToBaby@ucsd.edu or visit www.MotherToBaby.org.

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Media Contact: Nicole Chavez, 619-368-3259, nchavez@MotherToBaby.org.

 

 


Study Suggests Adalimumab Exposure in Pregnancy Does Not Increase Birth Defects Risk

February 14, 2017

Treatments Bring Unique Challenges during Pregnancy with Inherited Form of High Cholesterol, Says MotherToBaby

BRENTWOOD, TN – Just in time for February’s American Heart Month, MotherToBaby, a service of the international non-profit Organization of Teratology Information Specialists (OTIS) that is dedicated to providing evidence-based information to mothers, health care professionals, and the general public about medications during pregnancy, has launched a new observational study of high cholesterol and the medications used to treat it in pregnancy.

According to the Centers for Disease Control and Prevention (CDC), nearly 1 in 3 American women have higher than optimal low-density lipoprotein (LDL), also known as “bad cholesterol,” levels today. In addition, an estimated 1.3 million Americans have an inherited form of high cholesterol called familial hypercholesterolemia (FH) that may require them to stay on a cholesterol-lowering medication, even while pregnant.

“For women with FH, fixing the problem isn’t as simple as changing their diet and encouraging exercise,” said Maryam Tarsa, MD, a clinical professor and obstetrician at University of California San Diego School of Medicine who specializes in high-risk pregnancies. “Developing babies need cholesterol to form properly, so there is a theoretical concern that cholesterol-lowering medicines could pose pregnancy risk, but for moms-to-be with FH, avoiding cholesterol treatments could pose risks to both mom and baby,” she added. “The bottom line is, we need more information.”

For this reason, MotherToBaby hopes to empower women and their healthcare providers with the information they need to make the best treatment decisions for both mom and baby through its new observational research study. Compared to other research on cholesterol-lowering medications in pregnancy, unique to this study is the follow-up with moms and babies: babies will be eligible to receive a specialized non-invasive pediatric exam with a study doctor, and may be eligible for neurodevelopmental testing when the child is between 4-5 years of age. Participants are not asked to take or alter any medications, do not need to travel, and are not asked to make any changes to their normal routine. Women with and without high cholesterol, particularly FH, who are pregnant and who reside in the U.S. or Canada may be eligible to participate, and may call 877.311.8972 or visit MotherToBaby.org for more information.

“I think it’s very valuable to participate in this research so I can feel confident I am taking the best steps to ensure a healthy pregnancy,” said one mother-to-be who recently enrolled in MotherToBaby’s research program. “The information I can provide will lead to improved knowledge of best practices during pregnancy and ultimately better care for pregnant women.”

Health care providers as well as potential participants can also email questions about the study to MotherToBaby@ucsd.edu. MotherToBaby is recruiting 375 women for participation in the study.

More About MotherToBaby

MotherToBaby is a suggested resource by many agencies including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration’s (FDA) Office of Women’s Health. More than 100,000 women and their health care providers seek information about birth defects prevention from MotherToBaby every year.  MotherToBaby has been able to embark on new outreach efforts to reach underserved populations and launch new communication technologies through a cooperative agreement with the U.S. Health Resources and Services Administration, as well as through generous donations made by the public. To learn more about MotherToBaby, the ways to contact its network of experts, or how to support its services, please visit www.MotherToBaby.org.

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Media Contact: Nicole Chavez, 619-368-3259, nchavez@MotherToBaby.org. Interviews in Spanish can also be arranged.

 


Study Suggests Adalimumab Exposure in Pregnancy Does Not Increase Birth Defects Risk

Mental health conditions are real health issues that deserve appropriate and individualized medical care. Making informed healthcare decisions requires that women and their healthcare providers be aware of the available safety information for each specific medication they might be considering. We encourage pregnant women and those planning a pregnancy to have open conversations with their healthcare providers to carefully weigh any potential increased risks of medications, as well as the risks of untreated or undertreated mental health conditions.

SSRIs – including commonly prescribed medications such as Zoloft (sertraline), Lexapro (escitalopram), Prozac (fluoxetine), Paxil (paroxetine), and others – are among the most well-studied medications used in pregnancy. Decades of research have shown that SSRIs, when used appropriately and under the care of a healthcare provider, can be part of an effective treatment plan for managing mental health conditions before, during, and after pregnancy, and can contribute to better outcomes for women and their babies.

As always, MotherToBaby and the Organization of Teratology Information Specialists (OTIS) stand with women and their healthcare teams by providing up-to-date, evidence-based information on the use of medications and other exposures during pregnancy and while breastfeeding.

MotherToBaby offers free, expert-reviewed fact sheets on SSRIs and other medications, as well as on conditions such as depression, anxiety, and stress. You can find many of our mental health resources here: https://mothertobaby.org/pregnancy-breastfeeding-exposures/mental-health/. Individuals can also reach out to a MotherToBaby specialist via phone, live chat, text, or email to receive personalized, confidential support.


Study Suggests Adalimumab Exposure in Pregnancy Does Not Increase Birth Defects Risk

By Kirstie Perrotta, MPH and Sonia Alvarado, MotherToBaby California

With wildfires seemingly becoming a year-round problem, pregnant women have more questions than ever before about exposure to smoke and lingering poor air quality. Understanding the possible risks from a fire during pregnancy or while breastfeeding can help people make informed decisions when the unthinkable happens. Here are some commonly asked questions we receive at MotherToBaby about wildfires.

Q. What is in the air from the fires?
A wildfire produces particulate matter (a combination of dirt, soil dust, pollens, molds, ashes, and soot), in addition to other chemicals. The particulate matter can be different sizes. Particles less than 10 micrometers in diameter pose the greatest problems, because they can get deep into your lungs, and some may even enter your bloodstream. Contents of the smoke can vary based on what is being burned. In some instances, wildfire smoke can contain heavy metals such as lead. Wildfire smoke also contains carbon monoxide.

Q. I’m pregnant. How does the particulate matter affect my pregnancy? What about the carbon monoxide?
Experts tell us that the smaller the particulate matter, the worse the effects on health, including difficulty breathing, aggravated asthma, and increased risk of heart attack and death due to respiratory and cardiovascular problems. Although we do not know enough about how exposure to particulates can impact a pregnancy, it makes sense for all individuals to take extra precautions to reduce their exposure to wildfire smoke.

Carbon monoxide is a gas that enters into the lungs and blood and displaces oxygen to both mom and baby. The greater the exposure and the longer the exposure, the higher the risk. Studies suggest that there may be a higher chance of birth defects when a woman is exposed to carbon monoxide in the first trimester, but more studies are needed. Other studies have found that exposure to wildfire smoke can increase the risk for preterm delivery and low birth weight. However, this finding may be more related to the stress a woman experiences during a fire, or a combination of factors, than the actual smoke exposure. Again, more research is needed.

Q. I have asthma and I’m pregnant. Do I have added risks?
Yes. Studies in non-pregnant women tell us that exposure to particulate matter of 10 micrometers in diameter or less can make asthma symptoms worse. Pregnancy would not protect you and it may even put you at higher risk of having an asthma attack depending on how far along you are. See our fact sheet on asthma here.

Depending on your proximity to the fire zone, it may be difficult to get help if your symptoms worsen. First responders may be busy fighting the fires and evacuating residents and may not get to you as quickly as you need. Emergency rooms may be overrun. For this reason, it is very important to always have your asthma medication with you so that if the smoke exacerbates your symptoms you can start to treat yourself. You also want to be in contact with your doctor and move away from the source of the wildfires as soon as possible.

Q. I’m pregnant and work outdoors. Do I need a mask?
The U.S. Environmental Protection Agency (EPA) has recommendations about what masks to use to protect against particulate matter entering the lungs. The goal is to prevent or reduce exposure as much as possible. If you work indoors, for the most part you are protected. If you work outdoors, you may want to consider using a mask that fits correctly and has two head straps to hold it in place. It should be labeled “particulate respirator” and it should have been tested or approved by the National Institute for Occupational Safety and Health (NIOSH). Learn more here. Since pregnancy can alter your lung function, pregnant women may have a harder time breathing to begin with. For that reason, it’s important to check in with your healthcare provider before using a particulate respirator.

If you are concerned about your work conditions, NIOSH offers a program called The Health Hazard Evaluation Program. This program helps employees learn whether health hazards are present at their workplace and recommends ways to reduce hazards and prevent work-related illness. Learn more here.

Q. I live about 50 miles from the wildfires. Do I still have to be concerned about being outdoors?
Depending on where you live and the direction of the wind, the air quality in your area may be poor due to the wildfire, even if the fire isn’t that close to you. Listen to the local health and environmental officials, and avoid exercising outdoors, gardening, or performing other activities that may cause you to exert yourself and inhale more of the particulates in the air. If you have any doubts, wait until the wildfires have been extinguished and the air quality is back to normal.

Q: Can fires cause other problems for pregnant women?
Depending on weather conditions, wildfires can spread rapidly. The stress of having to make life and death choices, or the decision to leave your home and decide what items to take with very short notice, all produce tremendous stress. It is absolutely normal to feel sad, stressed, anxious, or scared. In pregnancy, depending on how long the stress is present and the level of stress, it is possible that there could be impacts on the developing baby, so anything you can do to try to reduce stress is always a good idea. Take a look at our fact sheet on stress for more information:

Q: I’m pregnant. What if I have to evacuate?
The best thing that you can do is have a plan in place ahead of time. Make a checklist of items to take with you should you need to evacuate your home. Assemble an emergency supply kit and store it in a location where you can easily get to it, and create a family communication plan.

When the time comes to evacuate, stay calm. Be sure to bring any medications that you take on a daily basis (including your prenatal vitamins). Stay well hydrated, continue to eat, and rest as much as you can. If you have to check into a shelter, tell the staff there that you are pregnant so they can make any necessary accommodations.

While making it to your prenatal check-up is probably the last thing on your mind in the midst of an evacuation, it’s important that you continue to be seen by your OB/GYN or midwife. Some individuals may be displaced from their homes for an extended period of time, however, it’s important to keep attending your prenatal care visits to make sure that baby is growing and developing properly.

If you’re close to your due date, check to make sure your hospital or birthing center is not in the mandatory evacuation zone. If it is located close to the fires, the staff and patients there may be asked to evacuate, and you may need to deliver at a different hospital. Knowing this information before you go into labor will reduce any unnecessary stress.

Q: What other steps can I take to minimize my exposure to smoke from a fire?
Stay indoors when possible, and keep your windows and doors closed. If available, an air purifier can help with indoor air quality. If you have to drive somewhere, keep your windows rolled up and use the air conditioner to stay cool. If your car has a button that recirculates air internally, make sure it is turned on. Pregnant women who must venture outdoors may also consider wearing a mask. Although any protection is helpful, a N95 particulate respirator works best to filter out harmful particulate matter.

Q. I’m breastfeeding and I’m concerned about the wildfires in my area
Breastfeeding moms can also face challenges of their own when they have to evacuate their homes. When possible, follow the steps outlined above to reduce exposure to the wildfire smoke for both you and baby.

The benefits of breastfeeding are well known, and in most cases individuals are encouraged to continue to breastfeed their babies even when faced with an emergency like a fire. Women who are nursing should focus on staying well hydrated and continue to feed baby on demand.

For moms that choose to pump breast milk, extra batteries may be something worth packing in your emergency supply kit in case the power goes out. For babies that are formula fed, it’s important to bring bottled water.

Q: Where can I learn more about fires currently happening and about air quality where I live?

The U.S. Department of Agriculture (USDA) Forest Service reports on large fires nationally. The EPA also has a website where you can check the air quality index in your local area. Pregnant women should follow instructions laid out for “sensitive individuals.” Lastly, the Centers for Disease Control and Prevention (CDC) has more helpful information about wildfire exposure during pregnancy here.


Study Suggests Adalimumab Exposure in Pregnancy Does Not Increase Birth Defects Risk

By MotherToBaby, a service of the Organization of Teratology Information Specialists (OTIS)

Why should pregnant women care about influenza? Isn’t Zika a bigger deal?

The second you get pregnant, the advice starts coming in from everyone. No eating unpasteurized cheese (Listeria!), don’t change the cat litter (Toxoplasmosis!), and definitely don’t travel to South America (Zika!). While these are all valid concerns, influenza tends to get forgotten, and dismissed as “just the flu.” The Influenza virus may not make sensational headlines, but it’s a serious problem every year, and pregnant women are especially vulnerable to this infection.

In 2009/2010, the United States (U.S.) experienced a flu pandemic. The flu hit the public hard, and many pregnant women were hospitalized. The U.S. saw higher rates of admission to intensive care units for pregnant women, and 109 pregnant women died from confirmed or suspected flu infection. In comparison, Zika virus, which received much media attention and continues to be a source of great concern for many pregnant women, rarely results in hospitalization and has not resulted in any maternal deaths.

5 Quick Flu Facts:

  1. The flu is a risk year-round, and is not limited to a particular area of the country.
  2. Changes with the immune system, heart, and lungs put pregnant women at an increased risk of developing serious complications from the flu, such as respiratory distress. Pregnant women who get the flu are also much more likely to be hospitalized, and can even die from influenza complications.
  3. Fever is a common flu symptom. Research shows that an untreated high fever early in pregnancy can result in an increased risk for a certain class of birth defects known as neural tube defects (spina bifida is one example).
  4. Being very sick from the flu can increase the risk of pregnancy complications such as miscarriage and preterm delivery.
  5. For pregnant women looking to ensure the healthiest start to life for their little one, influenza is an important infection to be aware of, and to try to prevent.

Is it too late to get a flu shot? It’s January, isn’t flu season over?

It’s never too late to get a flu shot! Flu season can start as early as October, and runs as late as May some years. However, research shows that the highest number of flu cases each year usually occurs in February. While vaccine effectiveness can vary from season to season, the flu vaccine is thought to reduce the risk of illness by about 50% to 60% when the flu viruses that end up circulating in the community closely match the viruses included in that year’s vaccine. Even during years when the flu vaccine is not a good match, it is still thought to provide some protection against the flu. If you haven’t received this year’s flu vaccine yet, talk to your health care provider as soon as possible.

10 Quick Flu Vaccine Facts:

  1. The best way to avoid getting the flu virus is to receive the flu vaccine.
  2. Women who are planning a pregnancy and women who are currently pregnant are strongly encouraged to get the seasonal flu shot as early as possible during the flu season.
  3. There is no known risk from getting the flu shot during pregnancy. The seasonal flu shot is an inactivated virus vaccine, which means that it won’t cause you to get sick with the flu.
  4. Pregnant women are asked to avoid the live attenuated flu vaccine (also called the nasal spray vaccine) as it contains a tiny amount of weakened live virus.
  5. There is no trimester during pregnancy when the flu shot has to be avoided.
  6. Studies of thousands of women who have received the flu shot just before or during pregnancy have found no increased risk for birth defects.
  7. Studies have found that when pregnant women get the flu shot, their baby is born with protection against the flu for anywhere from 2 to 6 months after birth.
  8. Most women who receive the flu shot will not experience any problems.
  9. A small number of individuals who receive the flu vaccine may experience soreness/redness/swelling at the injection site, headache, fever, nausea and/or muscle aches. Reassuringly, these symptoms are usually mild and go away on their own within a few days.
  10. Anyone with a severe, life-threatening allergy to any of the vaccine ingredients should talk with their health care provider before getting the flu vaccine.

Is there anything else I can do to avoid the flu?

In addition to getting vaccinated, healthy habits can further reduce your risk of getting the flu. Avoid close contact with other individuals who are sick. If you’re caring for someone with the flu (like a partner or a child), make sure to clean and disinfect common surfaces that may be contaminated with germs. Wash your hands frequently with soap and water. Cover your mouth and nose while coughing or sneezing, and practice good health habits like staying well hydrated and eating nutritious food.

If you develop symptoms of the flu, you should contact your health care provider as soon as possible. When indicated, antiviral medications may be prescribed (ideally within 48 hours) to lessen flu symptoms and reduce the risk of serious illness.

MotherToBaby is a suggested resource by many federal agencies including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration’s (FDA) Office of Women’s Health, and HRSA, and provides the most up-to-date information. More than 100,000 women and their health care providers seek information about birth defects prevention from MotherToBaby every year. Additionally, MotherToBaby conducts observational research studies in order to contribute more information to the published literature about a variety of exposures. To be connected with a MotherToBaby expert, please call (866) 626-6847, text questions to (855) 999-3525 (standard messaging rates might apply) or visit www.MotherToBaby.org.

REFERENCES:

Flu Shot Effectiveness: https://www.cdc.gov/flu/about/qa/vaccineeffect.htm
Flu Prevention: https://www.cdc.gov/flu/protect/habits.htm
Peaks In February: https://www.cdc.gov/flu/about/season/flu-season.htm
MTB Flu Shot Fact Sheet: https://mothertobaby.org/fact-sheets/seasonal-influenza-vaccine-flu-shot-pregnancy/
MTB Flu Fact Sheet: https://mothertobaby.org/fact-sheets/seasonal-influenza-the-flu-pregnancy/
MTB Antiviral Fact Sheet: https://mothertobaby.org/fact-sheets/antiviral-medications-treatprevent-influenza-the-flu-pregnancy/
Flu Shot Side Effects: https://www.cdc.gov/flu/protect/vaccine/general.htm
Flu Shot Protects Baby: https://www.cdc.gov/features/pregnancyandflu/index.html
CDC Illness/Death Stats: https://www.cdc.gov/flu/about/disease/burden.htm
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