Thursday, September 20, 2007

Prescriptions don't always come with pregnancy warnings

Physicians prescribe medications for women of childbearing age all the time. However, new research shows women who could become pregnant often aren't receiving counseling regarding the risk of birth defects for some classes of medications.

If you're not up to speed on how medications are classified with respect to pregnancy outcomes, here's a quick primer. The Food and Drug Administration (FDA) classifies drugs based on how teratogenic they are - or what is their capacity to cause abnormal development in an embryo or fetus. The FDA uses 5 categories to denote levels of safety.

Class A drugs show no evidence of causing birth defects in studies of pregnant women. Class B drugs show no risk for birth defects in the second or third trimester. In the first trimester there either is no research on these drugs, or human studies did not demonstrate adverse effects, while animal studies did. Class C drugs are those that either have caused birth defects in animal studies and there are no studies of women, or no studies (either animal or human) exist at all, so risks are unknown. Class D drugs have been shown to cause birth defects, but the benefits of use outweigh the known risks, as in the case of life-threatening illness or serious disease. Finally, Class X drugs have been shown to cause birth defects, and they are not recommended during pregnancy.

In a study published this week in the Annals of Internal Medicine, investigators reviewed the health records of nearly 500,000 women ages 15-44 in northern California, including detailed information about medications prescribed, prescriptions filled, and contraceptive use and counseling. They found that 1 in 6 women was prescribed a Class D or X drug, and internal medicine and family practice docs prescribed the largest share of these drugs. They also found nearly one-half of women who were prescribed a Class D or Class X medication did not receive any contraceptive counseling, even though these drugs are known to cause birth defects. Finally, fewer than one-half of women who filled a prescription for a Class D or Class X drug also filled a prescription for contraception or had previously been sterilized.

Why does this matter? Unplanned pregnancies are not rare - in fact research shows that 50% of American women ages 15-44 will have at least one unplanned pregnancy in her lifetime. As a woman of childbearing age, this may be one of those instances where you have to be proactive in your healthcare. If you're sexually active - or have even the remote possibility to be - and your doctor prescribes a new medication, you may want to ask about the risks during pregnancy, just in case. Better to have one awkward moment in the doctor's office than 40 weeks of wondering if your newborn is going to be healthy.

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