FDA label changes simplify medication safety during pregnancy
New labeling system requires medication labels to detail safety for pregnant women
“Is this medication safe to take while I'm pregnant?” is one of the most common questions that midwives and OB/GYNs get asked, and it has long been one of the most difficult questions to answer.
The current labeling classifies drugs into categories of safety for pregnancy and lactation. A, B, C, D, and X categories show increasing risk to a developing fetus or a nursing mother; however, these groupings tell very little about specific risks or benefits of a particular medication.
Although most women try to refrain from taking any medications while pregnant or breastfeeding, many women have chronic medical conditions or conditions that develop during pregnancy that necessitate prescription drug therapy. Asthma, diabetes, hypertension, and depression are just a few of the common problems that require medication during pregnancy.
Patients often hesitate to take a medication that is labeled as category C for fear of affecting their baby. Category C means that the drug has been shown to cause adverse effect in animal studies, but there is not enough evidence to support risk in humans. These medications seem to cause the most angst among pregnant women, as they weigh the risks and benefits of treatment with no clear information.
The FDA promises that the new labeling system will provide medication-specific explanations detailing the risks and benefits of the drug, based on available studies and information. It will also describe how much of the drug enters breast milk and the effects on a nursing infant.
The new system will also address possible medication effects on “Females and Males of Reproductive Potential,” according to the agency. This section will outline any potential risks for infertility or recommendations for contraceptive use or pregnancy testing when prescribing certain drugs.
These changes will begin on June 30, 2015, for new medications. Older medications will gradually be changed to the new labeling system, which could take many years.
Prescribing medication to pregnant and lactating women is a complex process of weighing the risk to the fetus or infant against the benefits for both mother and baby. The new system of drug labeling promises to encourage informed discussion and educated decision-making for providers and patients alike.
Robyn Carlisle, MSN, CNM, WHNP, works as a full-scope midwife at University Doctors and Kennedy University Hospital in Sewell, N.J.