FDA improves Drug Labeling for Pregnancy and Lactation

Change in FDA labeling for medication in pregnancy and breastfeeding

FDA improves Drug Labeling for Pregnancy and Lactation

Over the years, it has been challenging for psychiatrists to manage the risks of psychiatric medications in patients who considered childbearing, become pregnant, and chose to breastfeed. And while there is some information on many psychiatric medications, there remains little in regards to stimulant medications. Unfortunately, there is no registry for stimulant exposed pregnancy by which we can gain insight into their relative risk. The information we do have is related to animal research or people who have been active substance abusers. Very little of this research helps me in discussing evidence-based medication decisions with my patients. In my capacity as a researcher, I have had conversations about creating a stimulant pregnancy exposure registry with the pharmaceutical companies involved in ADHD but to no avail as yet.

With the proposed FDA changes in drug label for pregnancy and lactation, I hope we’ll have a better method of reviewing and evaluating relative risks and patients/families will be better informed.

The following article was distributed today, December 8, 2014 by the American Psychiatric Association, Psychiatric News Alerts.

FDA to Change Pregnancy and Lactation Labeling Information for Prescription Drugs

On Wednesday, the Food and Drug Administration (FDA) published a final rule that will set new standards for presentation of information concerning pregnancy and breastfeeding on labels of prescription drugs and biological products. The rule goes into effect June 15, 2015. “The [current] letter category system [A, B, D, and X] was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified view of the product risk,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, in a press statement. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, and the breastfeeding child.” The information provided under the new labeling requirements will be divided into the following categories:

Pregnancy: Containing information such as dosing and potential risks to the developing fetus and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug.

Lactation: Containing information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child.

Females and Males of Reproductive Potential: Containing information about pregnancy testing, contraception, and infertility as it relates to the drug.

“The new system is potentially more informative and more useful than the old grading system, … [but] a great deal will depend on the content of the information that is provided under the new requirements, particularly for psychotropic medicines,” stated Nada Stotland, M.D., a professor of psychiatry at Rush University and an expert in OB-GYN psychiatry, in an interview with Psychiatric News. “If the information provided is reasonable and clear, it should help decrease the anxiety both psychiatrists and patients may feel regarding these medication decisions.” Stotland, a former APA president, emphasized that psychiatrists must continue to inform the public about multiple treatment options—including psychotherapies and social support therapies—that can safely aid in lessening symptoms of mental illnesses during pregnancy. “If left untreated—or unsuccessfully treated—mental illness can have adverse consequences for both mother and child,” she emphasized.

David W. Goodman, M.D.