Researchers eventually discovered that the drug caused serious birth defects in infants. Between 10,000 and 20,000 babies worldwide were born with malformed or missing arms and legs.
The drug was pulled from the market. In the aftermath, clinical trials in many places, including in the U.S., became extremely cautious of testing medications in pregnant women.
Over the years, medical research and regulations have removed some of those severe reservations, but Srinivas said it’s been gradual.
The risks and benefits of medication use during pregnancy is still underresearched. A lot of what we know today is based on retrospective studies or data registries, which collect information on positive or negative outcomes after drugs come on the market and people start taking them.
Meanwhile, many women depend on treatments to manage mental health conditions, chronic diseases and pain. Srinivas said they sometimes succumb to a false cultural narrative that tells them all medication use during pregnancy is bad or harmful.
“Patients that have hypertension or diabetes or Crohn’s disease, not being on your medicines when you’re pregnant is actually quite harmful, not just to you, but also to the pregnancy,” she said.
This narrative and misconceptions about medication use during pregnancy can make mothers feel guilty, Srinivas said, and feel like they must choose between their own health and that of their infant when, ideally, both should be equally considered.
“It’s a pretty deep conversation about like, ‘How bad is your mental health disorder? Have you been hospitalized before?’ And then talking about all the risks of not being on medication when you have a pretty severe form of depression versus if it’s a little milder and you want to just kind of keep an eye on things,” she said. “It’s also not a one-size-fits-all approach. It’s really a conversation that’s pretty nuanced with that person.”
Efforts to make drug research more inclusive
Leading medical organizations and groups like the Society for Maternal and Fetal Medicine, the Coalition to Advance Maternal Therapeutics, the American College of Obstetricians and Gynecologists and the Society for Women’s Research all recommend including pregnant and breastfeeding people in drug research when appropriate.
A 2016 federal law created a special advisory group called the Task Force on Research Specific to Pregnant Women and Lactating Women and tasked members to identify gaps in research and make recommendations for future guidance.
A final report recommended declassifying pregnant women as a “vulnerable population” in research regulations, developing programs that prioritize the development of treatments specifically for pregnant and lactating people, and expanding the workforce of clinicians and researchers who specialize in obstetric and lactation therapies.
Some of those proposals have been achieved, but Srinivas said there’s more work to be done, especially in educating other health providers and patients on how maternal fetal specialists can help people make these decisions well before they even become pregnant.
“I’ve had a lot of conversations with patients that are like, ‘I’m not really sure I even want to do this, but I don’t know if I can,’” she said. “Those are exactly the kind of people that we see and that we like to see, to be able to help them make a good decision for themselves.”
