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 | A New Rx for Healthier Pregnancies
By Marilyn Kennedy Melia
Special to the Tribune
January 21, 2004
If they belly up to a bar or light up in public, pregnant women are likely to face icy stares--or outright condemnation--from strangers. But those well-intentioned observers might want to hold their ire if they see a pregnant woman twisting off a medicine bottle cap and gulping down a couple of pills. For years, the conventional wisdom has been that drugs are off-limits to pregnant women, because of the possible harm they could bring to the developing fetus. Often lumped in the same category as cigarettes or liquor, even most prescription medication was deemed taboo. Such a purist approach ignores the reality that pregnant women aren't immune to illness and that pregnancy itself can trigger dangerous health conditions, said Dr. Sandra Kweder, deputy director of the Food and Drug Administration's office of new drugs and co-chairwoman of the FDA's pregnancy labeling task force. When they're pregnant and in pain, women are asking for relief.
"Pregnant women are saying, 'We have accepted this dogma for a long time that we shouldn't be taking anything at all. But why shouldn't we benefit from the advances of science, too?'" Kweder said. The medical community is responding, with the last decade witnessing a pronounced shift in physicians' willingness to prescribe for pregnant or nursing patients, said Dr. Denise Elser of Advocate Christ Medical Center in Oak Lawn and vice chair of the Illinois section of the American College of Obstetricians and Gynecologists. "I think people were so afraid [to prescribe medication to pregnant women] 15 years ago that women were told to bite the bullet," Dr. Elser said. She noted that at one time, pregnant women suffering from hyperemesis gravidarum (severe nauseau and vomiting) were told "to go into a dark room with no telephone and no TV and we'd give her a cold compress for her head." Now, however, the belief that it's not in the best interest of the mom or fetus for the mother to suffer is prompting more doctors to write prescriptions or suggest over-the-counter medications, Elser said.
Hyperemesis gravidarum, more commonly known as HG, for example, can cause malnourishment in the mother and the fetus, she said. Some conditions, like high blood pressure, have long been treated with prescription medication, Elser said. But data gathered on the effects of drugs have allowed doctors to more confidently prescribe medication for a host of ailments, such as depression, epilepsy and hyperemesis gravidarum. "I have spent the last 10 years of my career worrying about the impact of [psychiatric] medications" on developing fetuses, says Dr. Zachary N. Stowe, a psychiatrist and director of the Pregnancy and Postpartum Mood Disorders Program at Emory University in Atlanta. "I've been wrong. I should have been worrying more about the impact of illness" on the mother and baby. Indeed, studies have linked untreated depression during pregnancy with premature labor and low birth weight, Stowe said. Choice can be agonizing. Still, especially if the medication is not being used to treat a life-threatening or dangerous condition or if the medication's use is deemed discretionary, such as for pain, women can often agonize about taking a drug. Victoria Williams, a clinical psychologist in Oak Lawn, said many women who experience postpartum depression also suffer symptoms of depression during pregnancy and should be medicated. "There is more research coming out all the time about [physical] changes in pregnant women who are anxious or depressed," said Williams, adding that the mother's stress hormones can harm a fetus. These mothers talk extensively with their doctors and other mothers in support groups before deciding to go on an antidepressant, Williams said. "I haven't seen one mom where it isn't a very thoughtful, deliberate decision."
Suffering depression and debilitating insomnia during her second pregnancy, Clare Staudacher of Chicago found she "got back on track" after going on an antidepressant. "For me it wasn't that hard of a decision," said the 35-year-old accountant. "I wasn't using [the antidepressant] as a crutch. I needed it to eat and sleep better." Before going on the antidepressant, Staudacher did some research online and "had a pretty good feeling" about the risks, she said. Now, she readily shares her experience with other expectant mothers.
By the time she was pregnant with her third child just over two years ago, Susan Carlson, 36, of Holland, Mich., said she had braced herself for another bout with hyperemesis gravidarum, which had been so severe in her previous pregnancy that she landed in the hospital. "I get bad so quickly," she said. "I am dehydrated in 24 hours. I either take medication or I am in a life-anddeath situation." Even though Carlson's condition posed a significant threat, she said that in her first two pregnancies, she avoided any prescription medicine. She tried acupuncture, which "helped in my second pregnancy, but not in my third. My midwife gave me a prescription with my third, which I waited to fill because it was so expensive. I ended up getting very sick and then taking it. I wish I had taken it when she first prescribed," Carlson said. Carlson also shares her experience with other mothers, mostly through online support groups. She also enrolled in a study by a Canadian hospital that is tracking the impact of drugs on pregnancies and babies.
The MotheriskProgram at the Hospital for Sick Children in Toronto, established in 1985, uses a network or researchers, including many in the U.S., to gather information on the effects of many drugs taken by pregnant and lactating women. That information gathering often leads to longer-term studies on the health of children born to women with drug exposures.
Prescribing with confidence
Dr. Gideon Koren, a pediatrician and clinical pharmacologist is the director and founder of Motherisk. Koren said enough data has been gathered on certain drugs to enable doctors to prescribe with
confidence. For instance, he said, numerous studies have been conducted examining the impact on children born to mothers who took Prozac during pregnancy, proving that the antidepressant is safe. Conversely, some drugs, such as ACE inhibitors, are known to be off-limits, he said. Because most studies don't ask pregnant women to enroll in clinical trials and thereby, in essence, experiment with drugs, researchers rely on women like Carlson, who are already taking a medication and agree to be studied. The FDA's Kweder is a strong advocate of more research and better labeling by drugmakers to help pregnant women not feel as though they are taking a risk if they fill a prescription. "It's wrong for every patient to be her own experiment," Kweder said. In the meantime, mothers have established their own information-sharing networks. On message boards of the HG Web site that Carlson frequents, women help each other grapple with drug dilemmas. "They are concerned about their baby, but they know medication is a necessity when they are violently ill," Carlson said.
Doctor calls for research
Given the profound impact on the well-being of both women and their children, research on drugs taken during pregnancy should be a top priority, but it hasn't received the attention it deserves, said Dr. Sandra Kweder, deputy director of the Food and Drug Administration's office of new drugs and co-chairwoman of its pregnancy labeling task force. "For an area where the stakes are so high, you would think there would be a large centralized effort to collect [information], but there isn't," Kweder said. "Cost and fragmentation in sources of information are just two reasons for this."
Although, since 1979 the FDA has required drugmakers to include information about the risks and benefits to pregnant patients in inserts aimed at health-care professionals, the requirement is woefully inadequate, Kweder said. Kweder devotes her energies to rewriting the regulations that will lead to labeling that's more clinically relevant to practitioners. She also wants to facilitate research in this area. Posted on the women's health section of the FDA Web site (www.fda.org) are registries seeking pregnant patients taking medications, as well as a list of organizations that have information about the effects of medicines during pregnancy.
Marilyn Kennedy Melia
Copyright � 2004, Chicago Tribune |
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