A new study says that pregnant women are taking more over-the-counter medication than ever. The question is, is that a problem?

Doctors nationwide regularly recommend that, when needed, their pregnant patients take such drugs as Tylenol, Robitussin and antihistamines for everything from the common cold to back pain to sleeplessness. But the study concludes that these medicines and others need to be studied a lot more before they can be considered safe for mother and fetus.

What the findings are "really documenting is use high enough to warrant concern," said Martha Werler, associate professor of epidemiology at Boston University's Slone Epidemiology Center and the lead researcher on the study.

In the report, which appears in the September issue of the American Journal of Obstetrics and Gynecology, researchers studied more than 10,000 mothers of infants. They found that about two-thirds of these pregnant women took acetaminophen products like Tylenol and one in six took a decongestant or an Advil-type product containing ibuprofen. Studies are underway to examine the effects of each drug.

Despite the widespread use of nonprescription drugs, "there isn't a paper trail like with prescription meds," Werler said. "It leaves you relying upon the consumer to be the best source of information."

Researchers say that over-the-counter drug use among pregnant women mirrors trends among the general population. while aspirin use among pregnant women decreased in the 1980s, acetaminophen use increased. When acetaminophen use in pregnant women leveled off in the 1990s, ibuprofen use increased after it became available over the counter. This was followed by an increase in naproxen (Aleve) use by pregnant women when it became available without a prescription in the mid-'90s. With antihistamines, chlorpheniramine (Chlor-Trimetron) use has decreased, while mid-pregnancy use of diphenhydramine (Benadryl) has grown over the last 30 years.

"Probably most of the medications are not strongly associated with birth defects," Werler said. "What we don't know is" the weaker associations.

But many obstetrical practitioners, particularly in the teratology field, which looks at abnormal fetal development, say the drugs are safe.

"Women should not be afraid to treat," said Karen Filkins, a member of the Teratology Society and an obstetrics/gynecology professor at the University of California, Irvine. "You want to treat things when you are pregnant just as vigorously as when you are not pregnant. Whenever anyone gets sick, there's a risk from the illness. Sticking with what we have the most information on is best."

Filkins added that if pain is causing sleeplessness, it should be treated. "Lack of sleep means you might have errors in judgment" that could result in injury, she said.

The American College of Obstetricians and Gynecologists (ACOG) says acetaminophen, antihistamine and aspirin are not known to harm fetuses. According to ACOG spokeswoman Stacy Brooks, "There's not enough documented evidence to say [these over-the-counter drugs] are harmful. As far as we know, they're not proven to be harmful."

Still, Filkins admits, "You are always weighing risk versus benefits. There will never be a time that we can say that anything is safe for any one group. If you can get by without anything, that's better."

For help in weighing those factors, she recommends calling a teratogen information services hot line; a list of these phone numbers can be found on the Internet at http://otispregnancy.org. In the Washington area, consumers can call a national hot line at 866-626-6847.

Helaine Landy, chairwoman of the obstetrics and gynecology department at Georgetown University Medical Center and a specialist in maternal fetal medicine, echoes Filkins's position. "The basic message is to take as little as possible, [but] if patients have pain, they should take Tylenol," she said.

Same goes for Barry Rossman, president of the medical staff at Inova Alexandria Hospital and an 27-year obstetrician.

"A common statement is that nothing is okay to take," he said. "We tell patients to call us to make sure a medication is okay. Usually we say weaker medications are okay, like plain Tylenol, plain Robitussin or Chlor-Trimetron."

Physicians need to compare risks of the medication against risks of not treating a condition, which may restrict a woman's activity, limit her ability to eat properly or affect her in other ways that can have negative effects on the fetus.

But this advice can be confusing for expectant parents. Even when sanctioned by doctors, any medicine use can make pregnant women nervous. Some recall the example of thalidomide, a sleeping pill briefly distributed in the United States in the 1960s, which caused severe birth defects.

Bethany Velasco, 34, of Washington said she was hoping to keep her use of over-the-counter medicines to a minimum during her pregnancy. But in her third trimester, she was hit with a cold that wouldn't go away. "The cold was just going on forever," said Velasco, who delivered a healthy baby boy earlier this month.

Her doctor told her to take alcohol-free cough syrup. When that didn't give her enough relief, Velasco consulted her internist, who put her on a five-day course of children's-grade antibiotics.

Shelley Ducker, 33, of Washington was not as worried about using over-the-counter medications. By the eighth month of her pregnancy, she was desperate. "I had back pain and horrible [acid] reflux and couldn't sleep," she said.

Her doctor told her to take Tylenol for her back, Zantac for the reflux and Benadryl to help her sleep. Ducker was happy to have some relief. "The Zantac made all the difference," said Ducker, who delivered a healthy baby girl in late August.

Ducker is glad she heeded her doctor's advice. Because of the drugs, she was able to get some sleep before her daughter arrived. "You can reduce a fair amount of your suffering," she said. "You have to find a way not only to survive but to enjoy your pregnancy."


Susan Breitkopf is a Washington area freelance writer. To comment on this story, send e-mail to health@washpost.com.

Women are using more OTC drugs in pregnancy despite a lag in safety data, finds a new report.