A Role for the Government
To meet this need for information, the government has stepped in with multiple efforts and agencies. For example, the FDA awarded two research grants -- unusual for the agency -- to university medical centers to study the effects of blood pressure drugs commonly used in pregnancy. In addition, the Centers for Disease Control and Prevention (CDC) launched the National Center on Birth Defects and Developmental Disabilities to study causes of fetal defects, including the effects of drugs during pregnancy, according to the center's founding director, Jose Cordero, M.D. And the Council on Family Health, a nonprofit organization that works with the pharmaceutical industry, teamed up with the FDA to launch a public awareness campaign to educate women on the safe use of medications and supplements before, during, and after pregnancy.
Even more important, the FDA has been working to do away with the current rating system and instead provide much more detailed information on what is known about a drug's effect on a fetus or a breastfed newborn. But Dianne Kennedy, the FDA’s MedWatch director, cautions it could take several years before any proposal for reform becomes policy.
While the proposal may change somewhat as it goes through the review process, Kennedy says drug companies will likely have to expand the section on each label about what is known of a drug's effects during pregnancy and breastfeeding. It would include references to all available studies as well as specific instructions for doctors, such as waiting until after the first trimester (when most of the fetal organs are formed) before using certain drugs.
The FDA is also proposing guidelines that would require companies to provide periodic reports on positive and negative experiences in women who are pregnant or breastfeeding. "In the past, we've waited for companies to issue spontaneous reports of bad outcomes," says Sandra Kweder, M.D., deputy director of the FDA’s office of New Drugs. "This rule would require a proactive approach."
What We Know Now
The FDA's plan is commendable, but at least ten million babies will be born before the proposed regulations make it off the drawing board. Until then, there is already information that's available to help women and their doctors make decisions on what drugs to take during pregnancy, the proper dosage, and when to take them.
Sources such as Motherisk, the Organization of Teratology Information Services (a network of groups that monitor the effects of substances on the fetus), the FDA, and the CDC will provide information to pregnant women or their doctors. These organizations often have knowledge of current research from government studies, as well as from smaller studies conducted by private obstetricians who observe how patients and their newborns respond to medications taken during pregnancy.
While data has been slowly accumulating for years, many researchers say that studies on pregnant women with AIDS helped push research along on many other drugs. According to the CDC, many anti-retroviral drugs given during pregnancy and intravenously at delivery now prevent the perinatal transmission of the virus.
In the past, says Dr. Spilker, most physicians tended to take a conservative approach and caution women who were on long-term medications to stop taking their drugs during pregnancy. Today these women can usually work with their obstetricians and specialists to develop a treatment plan to maintain the health of both baby and mother. Under the advice of several doctors, Jean Halbauer, 37, of Valhalla, NY, changed epilepsy medications or drug dosages during each of her three pregnancies, and is now the proud mother of three healthy young children.
The Need for Research
Drugs for chronic conditions during pregnancy have gotten a great deal of attention, but the truth is that information is needed on nearly every drug, says Smith. That's because about half of all pregnancies are unplanned, which means that a woman may be pregnant and taking almost any medication during the early weeks before she learns that she's pregnant.
Also essential is information on exactly what doses of a drug are necessary during pregnancy, says Nancy Green, M.D., medical director of the March of Dimes. Dr. Green says that many doctors are inclined to reduce the dose of a drug during pregnancy to lower the chance of harm to the baby. But changes in blood flow and hormone levels may actually mean that a dose has to be increased during pregnancy to remain effective. More research on basic physiology in pregnancy is needed, according to Catherine Stika, M.D., associate professor of obstetrics and gynecology at Northwestern University in Chicago. Dr. Stika says there is much to be learned about how a woman's body changes from one trimester to the next, which can affect how pregnant women absorb, metabolize, and excrete each drug.
Having good data empowers women to get the treatment they need, says Dr. Green. Case in point: The FDA switched an asthma drug, the Pulmicort Turbuhaler, from category C ("risk cannot be ruled out") to category B ("no evidence of risk in humans") after data on more than 2,000 women who had used it during pregnancy showed that the drug did not increase the risk of birth defects.
The switch was important news to Debbi Fernandez, a social worker from New York City who was thinking about trying to conceive her first baby and had recently begun using the Pulmicort Turbuhaler. "The drug has been so effective that I can run up a full flight of stairs to the train without wheezing," says Fernandez. "My doctor was already recommending that I stay on it, and the fact that there are published studies to back that up makes me feel so much more confident about staying on the drug."
