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Over-the-counter Drugs, Pregnancy: a Bad Mix?

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The Seattle Times


SEATTLE - Most women are concerned about taking drugs or drinking alcohol during pregnancy. But what about some relief for the common cold?

A new study from Boston University shows pregnant women often use over-the-counter (OTC) medications to cope with pain and other minor health problems. But comparatively little is known about the effects of these medications on the fetus.

OTC medications must pass through a screening process before the federal government designates the drugs as safe for sale without a prescription. But those tests are done in the general population, and rarely include pregnant women because of liability concerns.

"We're working without good, definitive information," said Martha Werler, an epidemiologist who led the study from the Slone Epidemiology Center in Boston. "Proceed with caution."

In an ideal world, doctors say, women would not take any medications during pregnancy - particularly during the first trimester, when the fetus is more sensitive. But many pregnant women do take medications, and often for good reason.

Some women with chronic diseases, from high blood pressure to diabetes, could do more damage to their fetuses if they stopped medication. Others suffer from nausea or stomach problems during pregnancy - problems that some OTC medications easily could relieve.

The key is to consult a physician, or a teratologist, before taking any medication during pregnancy. Teratologists are doctors who specialize in birth defects, what causes them and how to prevent them. It's their job to pick through the latest research with a skeptical eye.

Talking with a doctor is crucial, experts say, because drugs affect women differently as they move through pregnancy. And each pregnant woman brings a different medical history to the table.

"What's safe for one woman is not necessarily safe for another," said Dr. Mary Hebert, a professor of pharmacy at the University of Washington.

For example, many women will benefit from taking calcium supplements during pregnancy; a daily dose will strengthen their bones and could help their babies. But for a woman with a history of kidney stones, Hebert said, calcium supplements could increase the risk for new kidney stones.

Even as doctors urge pregnant women to be careful, they also warn against the onset of paranoia. Some women panic because they took OTC medications in the early weeks of pregnancy, before they knew they'd conceived.

"They think that some terrible thing has happened to the baby," said Hebert. "In most cases, that's not the truth."

Most OTC medications have not been found to increase the frequency of birth defects when they are used occasionally and at the recommended doses during pregnancy, said Dr. Janine Polifka, co-director of CARE Northwest, an organization of teratologists.

But the question of what is safe, and what is not, can be overwhelming - even to doctors. That's why the University of Washington set up CARE Northwest, a nonprofit group that offers free telephone consultations for patients and health-care providers.

"Most physicians are very busy professionals," said Polifka. "They don't have time to do a really good literature search on a particular drug - and the studies aren't always easy to interpret."

Because the research is so scant, doctors often are divided over the use of OTC medications. Some prohibit use of any medication during pregnancy. Others take the OTC designation as proof that the product is safe. Many make their recommendation by weighing the benefits of a given OTC medication against its possible risks.

The teratologists at CARE Northwest give advice on a case-by-case basis, taking into account the latest research as well as the patient's medical history. But Polifka offered a few guidelines to consider.

When used chronically and in high doses, she said, pain-relievers such as aspirin and ibuprofen have the potential to cause premature closure of a vessel in the fetal heart. Also, chronic, high doses of these medications late in pregnancy can delay the onset of labor in some women and cause other problems.

Although acetaminophen, or Tylenol, has similar effects to aspirin and ibuprofen, she said the risk of adverse effects is not as great.

As for cold medicines, Polifka said nasal decongestants, such as pseudoephedrine and phenylpropanolamine, have been weakly associated with an increased risk of gastroschisis, or incomplete closure of the abdominal wall, in infants whose mothers took these medications during pregnancy.

Some expectant mothers load up on vitamins, convinced it will help the health of their babies. But doctors say that high doses of vitamins, particularly vitamin A, can cause anomalies in the heart, the ear and other parts of the body.

Herbal supplements also are a concern. There are hundreds of them in different forms, none regulated by the Food and Drug Administration. The March of Dimes, in particular, warns against taking these supplements because so little is known about their effects.

The topic of drugs during pregnancy clearly needs more research, said Hebert, of the University of Washington. Last year, the National Institutes of Health gave a $3 million grant to the university to study how women's bodies handle and respond to medications during pregnancy. The University of Washington is one of four centers in the country to receive that grant; the others are in Georgetown (Washington, D.C.); Pittsburgh; and Galveston, Texas.

What is the safest, most effective dose of a given medication? What is the effect of the drug as the pregnancy moves forward? What are the long-term effects on the child, in terms of brain development? These are some of the questions Hebert hopes to answer over the next several years.

"Despite the fact that half the population is female, and most women have at least one child, we know very little about drugs in pregnancy," said Hebert. "It's the last frontier in drug development."



Some basic guidelines for taking medicine when you're expecting a baby:

-Always talk to your doctor before taking any medicine or herbal health product.

-If possible, avoid using medicines during your first trimester. This is when the risk to your baby is highest.

-Acetaminophen (Tylenol): Following label directions usually is safe for short-term pain relief during pregnancy.

-Aspirin (brand names include Bayer, St. Joseph): Avoid during pregnancy. It can cause low birth weight and problems during delivery.

-NSAIDs (nonsteroidal anti-inflammatory drugs): Avoid during pregnancy, particularly during the third trimester. NSAIDs can cause heart problems in the fetus. NSAIDs include ibuprofen (brand names include Advil, Motrin), ketoprofen (brand names include Orudis KT) and naproxen (brand names include Aleve).

Source: American Academy of Family Physicians


(c) 2005, The Seattle Times. Distributed by Knight Ridder/Tribune News Service.

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