Posts

Drug Categories in Pregnancy

Image
Pregnancy category FDA Pregnancy Risk Information: An Update The FDA published the  Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling , referred to as the “ Pregnancy and Lactation Labeling Rule ” (PLLR or final rule). In 2015 the FDA replaced the former pregnancy risk letter categories   on prescription and biological drug labeling  more brief and understandable  to both patients and healthcare providers. The FDA received comments that the old five-letter system left patients and providers ill-informed and resulted in false assumptions about the actual meaning of the letters. The new labeling system allows better patient-specific counseling and informed decision making for pregnant women seeking medication therapies. While the new labeling improves the old format, it still does not provide a definitive “yes” or “no” answer in most cases. Clinical interpretation...