FDA Proposes New Drug Labeling System for Pregnant Women

The Food and Drug Administration has proposed replacing a 30-year-old system for classifying prescription medications in order to provide women with far more detailed information about a medication’s risks and benefits during pregnancy and breast-feeding. Should the proposal be approved, new prescription drug labels would list the potential risks and benefits for both the mother and the fetus when taking the medication and how those risks might change during pregnancy. The new labels will help women become better informed about their prescription drugs, and doctors will be better able to counsel patients about using prescription drugs.

The Food and Drug Administration’s goal is to fix the existing “inaccurate and overly simplified view of prescribing during pregnancy.” On average, women take three to five medications during pregnancy, and more than 90% of nursing mothers take medication during the first week after delivery. The medication itself and the effects it carries with it can be passed on to the infant through breast feeding, so providing women with much better guidance about the medications they may take can be vital to the health of their child as well.

In addition, nearly 3 million annual pregnancies are unplanned, and as a result, many women are already taking medications before they even realize that they are pregnant. The current system provides virtually no guidance for women as to the risks that medications they are taking pose to a baby who has already been exposed.

The current prescription medication ratings system, which is based on a drug's risks as well as how much is known about the medication, is confusing to many doctors and patients. Harvard Medical School professor Michael Greene, who led an advisory committee for the FDA about the change, says that the categories in the current ratings system are very broad, and individuals often mistakenly assume that all the drugs in one category are equally safe.

The FDA’s new system will create a labeling method that provides updated, comprehensive information which outlines the risks to both mother and child during pregnancy and breastfeeding. The new system will also include the risks of failing to treat medical conditions and how the effects of prescription medications will change over time.

Drug companies will also be required to keep labels up to date under the FDA proposal. Currently, prescription medication manufacturers are only required to update their labels when they discover new risks or dangers, but they are not required to update a medication’s label if it has been found to be safer than previously thought. Because updating labels is time consuming and costly, drug makers have little incentive to make such changes in response to positive news. If labels are not updated in response to learning that drugs are safer, doctors may fail to prescribe them to patients who desperately need the medication because of previous risks.

The FDA hopes to begin rolling out new labels soon after the proposal has been reviewed and approved.