Friday, December 5, 2014

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.

For research on the use of psychotropic drugs during pregnancy, see the Psychiatric News articles, “Lithium Use in Pregnancy May Contribute to Birth Defects, Miscarriages” and “Certain Cardiac Abnormalities Not Linked to Prenatal Antidepressant Use, Study Finds.”



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