So many women face wrenching decisions about using medication during their pregnancies. Now, federal officials are finally inviting them to tell their stories. And they’re not holding back:

“I was on Zoloft for many years before I became pregnant with my first. Both my psychiatrist and OB/GYN would not give me an answer about if I should continue to take it.”

“For every condition that couldn’t be addressed with acetaminophen or antacids, I was out of luck. Several months later, when I forgot to take that list of medications on vacation with me and came down with a cold, I sweated bullets trying to recall whether medicated cough drops had been on the list.”


“I wish I came off the meds while I was pregnant but what was done was done.”

Their fears and frustrations are slowly stirring change. Congress last year created a task force through the National Institutes of Health to study why so few women can get reliable answers on medication use during pregnancy — and to recommend solutions. Members have been holding public meetings and reviewing the women’s comments. Experts say it’s long overdue.

Few drugs have been approved as safe and effective to use during pregnancy, and most of those are for conditions specific to pregnancy. As a result, almost every medicine given to a pregnant woman, from prescription antacids for acid reflux to biologic drugs to prevent epileptic seizures, is considered an off-label use. Some doctors even take women off medications as basic and important as those that help control blood pressure, because there’s no way of knowing if they’re safe.

The research “is pretty impressively minimal,” said Dr. Catherine Spong, an obstetrician who is leading the federal task force.

Another wrinkle: Because the body changes so much during pregnancy, standard doses might be too high, or too low, for an expectant mother, depending on how a specific medication is distributed and absorbed in the body.  There’s very little research on how to compensate for such shifts.

That’s left doctors and patients playing a dicey guessing game.

“It’s a risk-risk analysis,” said Adrienne Griffin, a mother of three who decided to take an antidepressant during pregnancy. “There’s risk to not being medicated, and there may be risks to being medicated.”

What do we know about how pregnancy changes how drugs work in your body? Very little. Here’s why. Dom Smith/STAT


STAT interviewed pregnant women and mothers, doctors, ethicists, and federal officials and reviewed hours of testimony to the federal task force to understand the scope of the problem.

The drug industry has long steered clear of research on pregnant women. Past tragedies loom large — starting with thalidomide, which was widely prescribed for morning sickness in the late 1950s only to cause devastating limb deformities in at least 10,000 babies.

Regulations, too, have long discouraged research on pregnant women out of caution. Researchers have to meet specific requirements to include them in experimental studies – and often don’t. And pregnant women are currently listed as an example of a “vulnerable population” in research, along with prisoners and people with diminished mental capacity. It’s a designation designed to protect people who might be at risk of being pressured into participating in a trial. They’re set to be removed from that list in January.

There’s deep concern over the ethics of exposing pregnant women to drugs that haven’t been proven safe for them or their fetuses. Just last week, in testimony before Congress, NIH Director Francis Collins laid out the dilemma. “This area of research is vital,” he said, “but it is absolutely critical that we carefully consider intentional exposures in this potentially vulnerable time of life.”

Doctors get that. Yet they point out that since so little research has been done, millions of women each year are already getting exposed to potentially risky drugs.

“Because we haven’t done that research, women are faced with those kinds of questions every day in the clinic,” said Dr. Anne Lyerly, a bioethicist at University of North Carolina, Chapel Hill. “They’re exposed to untested medications necessarily every day.”

Pregnant and panicking, women search for data

Julie Cerrone found out she was pregnant in July. Her first thought?

“Oh, shit. I’m on this medication,” she said.

A 32-year-old health advocate and blogger in Pittsburgh, Cerrone was taking the drug Otezla for her psoriatic arthritis. The condition — a type of inflammatory arthritis that can flare up and then subside — leaves her sapped of energy and overcome with aches. Her hands are often wrought with pain. Her knees sometimes swell so much it’s difficult to walk. At a friend’s baby shower last year, she realized she could never open gifts in front of her friends and family. It would be too hard on her hands.

Her symptoms got a bit better when she started the drug. So when she found out she was nearly two months pregnant, she panicked and called her physician.

“He said, ‘Well, this drug hasn’t been shown to be detrimental,’” she recalled. “I was like, ‘Well, it hasn’t been shown to be safe.’”

She talked to her gynecologist, rheumatologist, and dermatologist. Their consensus: Don’t take any medications unless you absolutely need them. There just wasn’t enough data to show whether the biologic would affect her fetus. She researched the drug on her own online, but came up essentially empty-handed. So Cerrone stopped taking Otezla and hoped for the best.

“It was really, ‘Well, I hope I’m doing the right thing,’” she said.

So far, her arthritis has been bearable; she hasn’t experienced a major flare-up. But Cerrone has heard from other women online that the condition often gets worse after giving birth. She’s concerned that if that happens, she’ll need to go back on the medication and won’t be able to breastfeed. There isn’t safety data on nursing while on Otezla, either.

“[Pregnant women are] exposed to untested medications necessarily every day.”

Dr. Anne Lyerly, bioethicist

Cerrone also faced another common problem during pregnancy: morning sickness.

“Except it was all-day sickness. I couldn’t keep my head up. I couldn’t function as a person,” she said. Her doctor prescribed Zofran, a common anti-nausea medication. It’s frequently used to treat morning sickness, but when Cerrone did her own research, she found conflicting anecdotes.

It’s a familiar theme: Pregnant women often turn to Facebook support groups and other online forums for advice — but rarely get a complete picture. After all, people are far more likely to report negative outcomes than positive ones. And they report correlations, not causation. About 3 percent of all newborns have some kind of birth defect; without rigorously controlled trials, it’s impossible to know whether a pregnant woman’s medication use affected her baby’s health.

“What people report are the bad things,” said Spong, the obstetrician who leads the federal task force, which is coordinated by the National Institute of Child Health and Human Development. “If someone’s on a medication during pregnancy and nothing untoward happens, you don’t report it. It’s not news.”

Cerrone ultimately decided to take Zofran — and continued to do so for two months — because she couldn’t keep any food down. She didn’t have a firm answer about the drug’s safety, but she knew for sure that not getting enough nutrition wouldn’t be good for the fetus.

She hopes there are no long-term implications for her baby. She’s due in March.

Doctors struggle to decide: Is a medication truly necessary?

Physicians face their own challenges in trying to advise pregnant patients.

“When I’m talking to patients, my advice is, if she doesn’t need the drug, don’t take it,” said Dr. Daniela Carusi, an OB-GYN at Brigham and Women’s Hospital in Boston.

But that involves a tough decision: When is a medication absolutely necessary? Pregnant women often find it hard to make that judgment call.

“They feel like their baby is an innocent bystander,” Carusi said. “But you can’t have a sick mother and expect a healthy baby.”

“When I’m talking to patients, my advice is, if she doesn’t need the drug, don’t take it.”

Dr. Daniela Carusi

Doctors do what they can. They look at the limited observational studies. They look at the data from pharmacokinetics studies on pregnant rabbits and mice. In many cases, they stick to older medicines when possible. They assume that if drugs have been on the market for decades, we’d know if they caused major problems for pregnant women.

“Often that’s the best that we can do,” Carusi said.

But that approach can raise additional thorny questions. Dr. Alison Cahill, a maternal-fetal medicine specialist, said she sometimes treats patients who’ve run through the gamut of drugs to treat their chronic disease before finding one that works.

If such a patient gets pregnant, Cahill has to weigh whether to keep her on the effective drug — which may be too new to have much of a track record in pregnant women — or switch her to an older medication that hasn’t worked for her in the past. “Then you have the drug exposure for a drug that isn’t working, and you have the fetus exposed to an untreated disease,” said Cahill, who practices in Missouri.

Many pregnant women talk about literally drawing up pro/con lists as they go through the agonizing internal debate.

“[My doctor] said, ‘Well, this drug hasn’t been shown to be detrimental.’ I was like, ‘Well, it hasn’t been shown to be safe.’”

Julie Cerrone, health blogger

Griffen, the mother of three in Arlington, Va., experienced severe anxiety and depression after her second child was born. She started taking antidepressants, but wasn’t sure what to do when she decided to have another child.

Her doctors didn’t have a clear answer, either.

They left it to her to decide.

“They were silent on the subject. They said, ‘Do whatever you think is best,’” she recalled.

Griffen felt she needed to stay on the medication: “I could not be a basket case with a 2-year-old and a 4-year-old,” she said. So she pored over studies on her own, checking to see if they were well-controlled and parsing out the relative risk of birth defects.

There’s been a fair amount of observational research on antidepressant use during pregnancy — but the findings from those studies don’t always point in the same direction. In some cases, the findings in a single study are contradictory.

One study in 2015 looked at 850,000 births in Finland and found that there were more short-term complications in newborns whose mothers took antidepressants during pregnancy. But that study also found there was a lower risk of preterm birth among women who took antidepressants compared to women with psychiatric disorders who didn’t take medication during pregnancy.

Or consider the confusion over a potential link between antidepressant use during pregnancy and autism spectrum disorder in children.

One study, published in April in the Journal of the American Medical Association, found that use of common antidepressants during pregnancy wasn’t associated with a significantly increased risk of autism spectrum disorder. The authors suggested that the link between the two — which had been reported in many other studies — might actually be explained by other factors, like genetics.

A study published in the BMJ three months later, however, concluded that the link might not solely be due to those other factors.

“It’s a risk-risk analysis. There’s risk to not being medicated, and there may be risks to being medicated.”

Adrienne Griffin, mother of three

In short, nothing’s definitive. And media coverage can make the decision even more confusing, frustrating, and frightening for pregnant women.

One publication ran a story about the April study with the headline “Anti-depressant use before, during pregnancy tied to autism risk.” Another publication ran a story about the same study with the headline “Studies find no evidence for autism link to antidepressant use.” The July study received similarly contradictory coverage.

Ultimately, Griffen decided to stay on her antidepressant, Zoloft. But she knows not every woman has the education — or the time — to do the kind of research that made her comfortable with that decision.

Women with chronic disease face even tougher choices

For pregnant women with chronic diseases like sickle cell anemia, Crohn’s disease, or epilepsy, decisions about medication use grow exceedingly complicated.

Clair Cobbold, 32, was diagnosed with epilepsy when she was 18. When she decided to have a family, her epilepsy specialist walked her through the research on anti-seizure medication in pregnancy and the risk of birth defects, which is elevated with some anti-seizure medications.

“She was honest with me about that and allowed me to make my own mind up,” Cobbold said.

At that point, she was taking a drug called lamotrigine and was having about one major seizure a year. “I was on one of the safest [drugs] they could see,” she said.

But Cobbold knew “one of the safest” doesn’t guarantee “safe.” She weighed her options. There’s no warning when she’s about to have a seizure — they sneak up on her and she drops to the floor. She worried that if she had a seizure while on the stairs, she might fall and harm the fetus.

“Epilepsy is always a bit of trial and error. But I felt by taking the medication, it was safer than me having a seizure,” she said.

She did have a seizure early on in her pregnancy. Cobbold’s doctor increased her dose, hoping that would help keep the seizures in check. Her daughter was born healthy, without any major birth defects.

Between her daughter’s birth in 2012 and her son’s birth in 2015, Cobbold’s seizures became more frequent. Her physicians decided lamotrigine wasn’t going to cut it anymore. They switched her to a drug sold under the brand name Keppra. There wasn’t a solid answer on whether it was safe to take during pregnancy — but she knew she needed the medication. Pregnant and in charge of an active toddler, she couldn’t risk falling from a seizure.

“There wasn’t the option of me not being on medication,” she said. “It was the safest of all my options.” She made it through her pregnancy without a seizure, and gave birth to a healthy boy.

But her decision to stay on the seizure medications during pregnancy still nags at her.

Cobbold has been trying for three years to potty-train her daughter, who has an overactive bladder. It’s not a complication that’s ever been tied to anti-seizure medication use during pregnancy. But she has heard similar stories in Facebook support groups from other moms who took the same medication while pregnant.

She asked her neurologist, who first walked her through the decision to take the medication during pregnancy. He told her there’s no way to know whether the drug is connected to her daughter’s bladder issues. There isn’t any research.

Part 2 refer

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  • The medical profession is facing a crisis on different front. They need to implement acupuncture( TCM) fully into the healthcare system.

  • Health lifestyles that combine sensible eating with regular physical activity increase your quality of life. Overweight or obesity increases your risk for high blood pressure, high blood cholesterol, heart disease, stroke, diabetes, and certain types of cancer, arthritis, and breathing problems. Proper weight is key to health and a long life. For adults and children, different methods are used to find out if weight is about right for height. If you have concerns about your child’s body size, talk with your physician.
    more information at

    • Ms. Women,

      Although I agree with most of what you’ve written. Being obese is one of the factors. As you getting older it is good to have sustainable fat, not obesity. A well around diet, because at > 65yr you at a higher risk of any disease, EX: Flu, peumonia, bacterial infections, immune diseases, not only heart diseases. Being old increase the likelyhood of diseases therefore; being sick decreases you weight gain due to a lot of factors therefore; having a little weight (not obesity) will help the body/ the immunity to be robust.

  • I’ve been trying to find the updated list of “vulnerable populations” in research and cannot find one without pregnant women listed in it. Have they not been removed?

  • The European Union voted to end use of dental amalgam fillings in pregnant and nursing moms and children under 15 years of old as of July 1st due to its 50% mercury content, which off-gasses with heat and abrasion. It has already been banned in much of Scandinavia and Japan.

    Why is it not even raised as a health issue in the United States? Could it be due to the power of the American Dental Association, whose affiliates held patents on it as recently as 1995, and that has gag clauses in its Code of Ethics regarding a product on which this professional association has fundamental conflicts of interest?

    It is time for the FDA to heed the concerns of its two expert dental products panels, and comply with federal court rulings to warn the public and parents of potential side effects, health risks and contraindications – as it requires manufacturers to warn dentists. Children and adults with fairly common genetic methylation variants are at greater risk of harm, as mercury bioaccumulates over time when it is not excreted.

    Unfortunately, dental work to remove or replace amalgams raises mercury exposure even further. Biological dentists have special training and equipment that go way beyond a dental dam and high speed water drill to remove it safely when medically indicated. Add dental amalgam to the list of FDA approved drugs and medical devicces that mothers need be be concerned about regarding health impacts.

  • Pregnant women and healthcare providers have easy access to a free/confidential local information service that will gather all the available data for them and help them interpret it: Mother-to-Baby Massachusetts serves caller from most New England states and can be reached via phone (800-322-5014), text (855-999-3525) or email ( Callers can ask questions about medications, home/workplace chemicals, non-prescribed substances, herbal supplements, etc. The response is based on up-to-date databases and is in straightforward language. Mother-to-BabyMA is funded locally by The Genesis Foundation for Children and is a member of OTIS (Organization of Teratology Information Specialists), a national group providing similar services to callers around the country.

  • Great article. Did you know about the many efforts and databases that are available to help women and heath professionals provide information about pregnancy and drug risk? As one example, a group at the University of Washington with a database called TERIS is working with a business in Michigan in an NIH (through CDC) funded project to make such data available on mobile devices. The press release, @, has more information.

  • Over the last few decades, I have had a variety of side effects from a variety of prescriptions that I thought were perfectly safe as they were FDA approved, until I learned they were not “right for me.”

    Unless it was an antibiotic for an infection, or for a life threatening condition such as excessive bleeding, I would not take it. So many things pass through the placenta to the developing fetus, whose nervous system and developing brain are exquisitely sensitive to substances foreign to their nascent immune systems. Hormonal changes also influence mothers’ need and response to medications.

    Rather than RCTs, set up registries in which pregnant women who do or did take prescription medications are invited to report through the convenient MedWatcher app, and track and compare them with data from women who did not take such Rx. I think this is the only ethical approach given the potential lifetime risk of harm.

    In addition, women should refrain from dental amalgam restorations during pregnancy. Europe is banning dental amalgam placement in pregnant women and children under 15 starting July 1, 2018, as there is definitive proof mercury from amalgams travels through the placenta and in breast milk and concentrates in fetal organs, in animal and human studies. Much of Scandinavia and Japan have already banned them altogether, and other nations are phasing them out.

    Given the rising rates of allergies, ADD/ADHD, autism, diabetes, obesity, rashes, and other health challenges among U.S. children, it is clear that gut microbiota are changing, and immune, metabolic and neurological disorders are rising. The last thing we need is to increase exposure to wild cards among fetuses and young children, as happened in the past with thalidomide, DES, and acrodynia/Pink’s disease.

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