Pregnancy and Drug : Pre-Pregnancy Planning, Untreated Disease

by Food and Drug Administration (FDA)

(Page 3 of 3)

Some drugs, such as oral contraceptives, land in Category X simply because there is no reason to use them in pregnancy. And a drug can fall into Category C because there is some medium level of risk based on animal studies, or because no animal studies have been conducted.

Since 1997, the FDA has been developing a new regulation that will revamp the pregnancy labeling system. The proposed regulation would replace the letter categories with more detailed, narrative descriptions. Information on fertility, pregnancy, and breast-feeding would be included.

Pooling Data

Enhancing data collection is critical for making a new labeling system meaningful for health-care professionals, says Kweder. As part of a large, new safety reporting regulation that the FDA is developing, drug manufacturers would be required to provide periodic reports on positive and negative experiences in women who are pregnant or breast-feeding.

"In the past, we've waited for spontaneous reports of bad outcomes," she explains. "This rule would require a proactive approach — looking for data from different sources and trying to understand how they enhance our understanding of a given drug's safety profile."

The FDA is also working with the Centers for Disease Control and Prevention (CDC) on strategies for more comprehensive data collection. "CDC has birth defects surveillance, FDA has spontaneous event reports, some companies conduct pregnancy registries, and clinicians are seeing their own cases," Kweder says. "But there is no way yet that we can systematically bring all of this together, and that's the direction we need to go."

Pre-Pregnancy Planning

Imagine finding out you're two months pregnant, and then you remember all the cough medicine and aspirin you took over the last few weeks, not to mention the herbal teas you drank. That's when the panic usually sets in.

The risk of adverse effects on a fetus is greatest in the first several weeks of pregnancy when major organs are developing. Pre-pregnancy planning increases the likelihood of having a healthy baby.

Half of all pregnancies in the United States — more than 3 million a year — are unplanned, which means the potential for accidental exposure to medication is high.

Over-the-Counter Concerns

While many over-the-counter (OTC) drugs can be used during pregnancy under a physician's supervision, some are known to be unsafe. As indicated on product labels, women who are pregnant, who may be pregnant, or who are nursing should consult a doctor before taking OTC medication.

Aspirin is one OTC drug that should be avoided in the last three months of pregnancy. In 1990, the FDA issued a warning that it is especially important not to use aspirin during the last trimester of pregnancy unless specifically directed to do so by a physician because it may cause problems in the unborn child or complications during delivery. OTC non-steroidal anti-inflammatory drugs such as ibuprofen also carry the same warning about use during the third trimester.

Experts stress that we don't know enough about the effects of herbs and dietary supplements on a growing fetus to determine whether they are safe to use during pregnancy. Don't assume a product is safe during pregnancy because it is sold over-the-counter and labeled as "natural."

The Danger of Untreated Disease

Fear of taking medication in pregnancy is understandable, but there are times when under-treating or not treating a condition can be dangerous, or even life-threatening. For example, a parasitic infection called toxoplasmosis, which you can get from cat feces or eating infected meat or soil, can infect infants and cause problems with the brain, eyes, heart, and other organs. The infection requires antibiotic treatment.

For all pregnant women infected with HIV, the CDC recommends the drug zidovudine (AZT). Research has shown that the drug decreased by two-thirds an HIV-positive mother's risk of passing the infection on to her baby, and neither mothers nor babies had significant side effects other than mild anemia. Uncontrolled diabetes increases the risk of miscarriage and stillbirth.

Uncontrolled asthma can decrease oxygen in the fetal blood, possibly impairing fetal growth and survival. And uncontrolled high blood pressure increases the risks of placental problems and fetal growth retardation.

Melissa Moore-Sumter, 28, of Temple Hills, Md., was diagnosed with lupus in 1991, and says her doctor monitored her closely throughout her pregnancies. She needed various medications, including a drug for high blood pressure when she was pregnant with her daughter Sade, now 8. "I didn't want to be on any medication," Melissa says, "but I knew I needed it." It's important to talk with your doctor about whether the potential benefit of taking a medication outweighs the risk for you and your baby.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.