When Laura Wylie became pregnant for the second time, she confronted a vexing dilemma: stay on the antidepressants that could have adverse effects on her developing baby or risk descending into a deep, black hole that left her feeling numb.
"You can't go through a healthy pregnancy if you're not in a healthy state of mind," said Wylie, 35, of Oak Park, Illinois. "I finally realized that if I had a broken leg, I wouldn't be expected to fix it myself. ... The same thing is true with depression."
For years, cautious mothers-to-be and their obstetricians thought "just say no" was the most prudent approach to any medication more potent than a cough drop. But abandoning treatment for chronic health conditions -- such as depression, asthma or diabetes -- can sometimes affect the baby more than taking a medication while pregnant, experts said.
BALANCING THE RISKS
To help doctors and patients weigh the risks and benefits of taking medications during pregnancy and breast-feeding, the Food and Drug Administration in June will require a new labeling system for prescription drugs.
"Should we let women with epilepsy just have seizures?" said Dr. Katherine Wisner, a professor and psychiatrist at Northwestern University Feinberg School of Medicine, who advised the FDA on the changes. "Pregnant women get sick and sick women get pregnant. But somehow we have created this myth of the medication-free pregnancy."
The revisions to prescription guidelines -- the first since 1979 -- will provide more up-to-date and specific information to doctors to help them identify the safest treatment options for common conditions during pregnancy, said Wisner, who specializes in maternal mood disorders.
The old system relied on letter grades of A, B, C, D and X -- A for the most benign medications to X for off-limits. The new system is designed to give physicians more technical information when prescribing medications, said Sandy Walsh, an FDA spokeswoman.
The updated prescribing guidelines consist of three components. The first gives physicians information on dosing and risks to the fetus. It also indicates whether data has been collected to show the drug's effects -- something never required until now. The second offers what is known about the drug's impact on breast-feeding, and the final section addresses how the product may affect fertility.
The change comes at a time when a growing number of women are taking medications during their childbearing years. According to the Centers for Disease Control and Prevention, 90 percent of all women are on at least one prescription or over-the-counter drug, while the use of four or more prescriptions has more than doubled during the past 30 years.
RATE OF BIRTH DEFECTS
Even when a pregnant woman takes no medication, the overall risk of birth defects is 3 to 5 percent, according to Suzanne Gilboa, an epidemiologist with the CDC's National Center on Birth Defects and Developmental Disabilities. It's often difficult to tease out what is a drug-related defect and what is not.
Pregnant women typically are excluded from double-blind, placebo-controlled clinical studies, "so a lot of what we know is from post-marketing surveillance and retrospective studies, which have more limitations," Gilboa said.