Expectant mothers face uncertainties when taking prescription drugs
When the throbbing headache pain strikes, it can knock Laura Kabulski to her knees or leave her bedridden.
She has had chronic migraines since her teen years. Without strong prescription medication to prevent them from occurring in the first place, functioning sometimes becomes nearly impossible.
Twenty weeks ago, Kabulski, 31, of Shaler and her husband, Adam, celebrated news that she was pregnant with their first child.
An accompanying barrage of worsening migraine symptoms, such as increased light sensitivity and intense vomiting, quickly quelled that celebration.
“I’ve been to the emergency room twice since my pregnancy began because I couldn’t keep any liquids down,” she said. “I can’t make it to work if I don’t take something to ease symptoms.”
One adjustment made quickly by Kabulski’s doctor was taking her off the migraine-preventing medication Topamax, which could potentially cause birth defects such as cleft palate.
She takes two pills daily. One is Imitrex, a migraine medicine that narrows blood vessels around the brain; the other is metoprolol, a blood pressure medication.
Kabulski still doesn’t know for certain whether those medicines are safe for her unborn child. Mothers across the country in similar situations face the same uncertainties for complications including morning sickness and gestational diabetes, or chronic conditions such as depression, epilepsy and high blood pressure.
About 70 percent of pregnant women in the United States take at least one prescription drug, according to the Centers for Disease Control and Prevention. However, most drugs are not tested on pregnant women for safety and effectiveness.
Less than 10 percent of medications approved by the Food and Drug Administration since 1980 have enough information to determine their safety, according to the CDC.
“It leaves us in a quandary,” said Dr. Richard Beigi, vice president of medical affairs and chief medical officer for Magee-Womens Hospital of UPMC. “Pregnancy changes a woman’s physiology dramatically, and there’s a dearth of data on medications and interventions that pregnant women are using.”
Beigi and experts from Magee-Womens Research Institute are working to find safe and ethical ways to test medications during pregnancy and lactation, two populations avoided by researchers for decades.
On a national basis, Maggie Little, a bioethicist at Georgetown University, is part of a group being funded by the National Institutes of Health to conduct more research with pregnant women.
She said half a million American women experience significant illnesses annually that require medication.
“It touches so many women’s lives and their families,” said Little, director of the Kennedy Institute of Ethics at Georgetown. “Right now we are caught in a terrible Catch-22: Because we don’t know much, we don’t know what to tell women. Pregnancy is an off-label condition.”
There are three main hurdles: First, current regulations surrounding performance of research during pregnancy significantly limit the opportunities for investigation. Second, many women understandably are hesitant to take part in drug trials. Third, researchers, pharmaceutical companies and universities are leery of complications during such studies.
Beigi referenced the 1950s when the nausea-relieving drug thalidomide caused birth defects and deformities. At least 10,000 “thalidomide babies” were born around the world before the drug was banned in the early 1960s.
“The reaction to those unfortunate occurrences was ‘let’s avoid pregnant women and research in general,’ ” Beigi said. “What is needed is the ability to protect pregnant women through research, not from research. This can be done with an eye toward safe and thoughtful investigations as opposed to avoiding pregnant women altogether.”
The idea of improving research on pregnant women has gained momentum as new threats such as the Zika virus rise to the forefront.
“If we get a vaccine for Zika, you better believe pregnant women need to be some of the folks who get that vaccine,” Little said.
Zika is known to cause microcephaly, in which babies are born with dangerously small heads.
“There is a huge need to generate more data for all of the drugs that pregnant women need to take,” said Dr. Christina Chambers, a professor of pediatrics and family and preventive medicine at the University of California at San Diego. “Being pregnant doesn’t take away the need for a pregnant woman to take an antibiotic or need to take an asthma medication. Pregnant women are an orphan population not having this data and information.”
Chambers also works as program director for the California office of MotherToBaby, an international organization that helps lead a network that provides information about the safety of medications during pregnancy and breastfeeding. It is run by the Organization of Teratology Information Specialists.
Chambers said many women learn about the lack of research for various medications only when they become pregnant.
“Most people are appalled by this,” she said. “They’re saying, ‘You’re kidding me. There’s no data available?’ ”
Kabulski, who works as a nurse practitioner for UPMC, felt the same way.
“I understand the various risks and benefits of medication from working in health care,” she said. “But I am still, in the back of my mind, wishing there would be more research on the meds I am taking, to have more reassurance. Like any mom out there, I want to have a healthy pregnancy and a healthy baby.”
Ben Schmitt is a Tribune-Review staff writer. Reach him at 412-320-7991 or email@example.com.