Reprinted from Common Health
Joy Shapiro of Framingham, Mass., was the sort of hyper-cautious expectant mother who doesn’t just cut out alcohol and caffeine. She worried about the ingredients in everything she consumed or put on her body, from fitness drinks to sunscreen.
But thanks to a referral from her obstetrician, she had a secret weapon against her anxiety: Patricia Cole, the program coordinator for MotherToBaby Massachusetts — also known as the Pregnancy Exposure Infoline — whom she “bombarded” with queries.
“At one point, I emailed her like 20 ingredients that were in my face cream to say, ‘Are any of these going to be a detriment to my pregnancy?’” Shapiro says. “You’re essentially living for two, and you want to make sure you’re not doing anything that could harm your child.”
Cole helped Shapiro navigate not just food and cosmetics but medications — prescription steroids, acid reflux, nasal sprays. The sorts of decisions that have become commonplace, nearly universal, in a country where 9 out of 10 pregnant women take at least one medication during pregnancy, and 7 out of 10 take a prescription drug.
“Less than 10 percent of approved medications have enough data to show what, if any, concerns there are for fetal effects.”
Many of the old concerns about risky exposures during pregnancy — leaded paint, thalidomide — have faded, but in this nation of prescription-fillers, meds have become a major worry.
Last year, the CDC launched its Treating for Two Website, part of a national initiative aimed at making medication use during pregnancy safer. It seeks better research on the effects of meds during pregnancy, and better guidance for expectant mothers and their doctors. The agency warned just last month about the potential risks of opioid painkillers — such as codeine or oxycodone — for pregnant women.
“Really, the problem is that we just don’t know a lot of information,” says Dr. Cheryl Broussard, a CDC expert on medication use during pregnancy. “We know that up to 9 out of 10 pregnant women take at least one medication during pregnancy, but less than 10 percent of approved medications have enough data to show what, if any, concerns there are for fetal effects.”
Clinical trials on drugs seeking approval generally do not include pregnant women, or drop women if they become pregnant.
The CDC sums up the problem in a poster.
Among the Websites that the CDC’s Treating for Two recommends is MotherToBaby, particularly its extensive fact sheets on specific drugs.
MotherToBaby’s origins go back over 30 years, to efforts by teratologists — specialists in birth defects — to provide pregnant women with more and better information about preventable birth defects. These days, many of the calls concern medications, though mothers-to-be have other exposure concerns as well.
Patricia Cole offers these examples of calls that come in to her:
• “I’m wondering about the new Brazilian hair treatment. I’ve very interested but I’m concerned because I’m told there is formaldehyde in it, and I just want to know, is it safe for me and my pregnancy?”
• “I’m a lab technician and I’m wondering about the chemicals I work with. I’m very early in my pregnancy and I really do not want to tell my boss yet, but I’m wondering, will it be safe for me to continue working with these substances?”
•”I’ve been taking Flonase for years, and I just want to know, is this the best allergy medication when you’re pregnant?”
The MotherToBaby counselors do not recommend for or against specific medications; they just share the risk information and suggest that pregnant women follow up with their doctors about their best course of treatment.
Sometimes fathers-to-be call as well, Cole says, as in: “I was doing a project in the garage, I thought everything was okay, but then my wife came screaming at me, saying the smell is horrible, and now I’m wondering if I compromised the pregnancy…”
You might think pregnant women would be lining up to get free, evidence-based counseling from Cole, and her counterparts at more than a dozen MotherToBaby offices around the country. But national call volume to its toll-free number –866-626-6847 — is down in recent years, and the Massachusetts office now gets a little over 1200 calls a year, compared to more than 2,000 a few years ago, Cole says.
Patricia Cole at the MotherToBabyMA hotline office in Waltham. (Courtesy)
“I think everyone is going to Dr. Google,” says Robert Felix, president of MotherToBaby’s national organization. “But you have to be careful,” because online information is not always accurate.
Obstetricians and their staffs should be pregnant women’s primary source of information, Felix says. But they tend to be busy.
“Whereas when we get people on the phone, we can talk to them anywhere from 10 minutes to as long as two hours,” he says. “We have the knowledge, we have the time.” And, he says, often the counselors can defuse mothers’ anxiety by reviewing the data with them, though it may be complex. “We really can take some complex information and simplify it as best we can so the mom can understand it,” he says.
Felix, Cole and the other MotherToBaby counselors are operating in a minefield, of course. They must navigate running controversies around the use of antidepressants during pregnancy, among other debated drugs.
More studies on medications in pregnant women are badly needed, says Dr. Broussard of the CDC.
Ideally, she says, a woman will check on medication safety and adjust accordingly before she becomes pregnant, because many birth defects begin early in a pregnancy.
And “once a woman goes to her physician and has a discussion about medications, we want the physician to be able to have reliable information to consult. And so in order to have that, we have to have more studies, and more data to inform the guidance.”
Some of the women who contact MotherToBaby are invited to enroll in observational pregnancy studies to see if medications they’ve taken have any effects on their babies.
MotherToBaby’s funding comes from philanthropies, the federal government and a variety of other sources, Felix says; it also receives research funding from pharmaceutical companies to support such observational studies on the effects of their drugs in pregnant women.
But “We’re not biased by any pharmaceutical company,” he emphasizes. “The information we provide is evidence-based. If you were to go into PubMed” — a public database of published studies — “and do the research yourself, that’s what you’d find.”
As the federal government ramps up its efforts on safe medication use during pregnancy, MotherToBaby recently received a $2.4 million grant from a maternal health agency to expand its work, particularly with underserved and hard-to-reach mothers.
The demand for MotherToBaby’s services may also grow in the coming months as the Food and Drug Administration shifts its drug labeling away from letter labels — currently, drugs may be categorized A, B, C, D or X in terms of their risks for pregnant women — to a more descriptive label that does not include a letter grade.
In his own MotherToBaby counseling work, Robert Felix has heard many a pregnant woman laden with guilt and anxiety and fear. He wishes more of them knew, he says, that “For the most part, it works out well. For the most part.” MotherToBaby counselors, he says, can address their concerns, clarify their misconceptions, and often even provide some peace of mind.
After her daughter, Ellie, was born two years ago, Joy Shapiro sent Patricia Cole baby photos and a note of gratitude: “Thank you so much, and she’s healthy and great.”
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