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FDA Enforces New Drug Safety Labeling for Pregnant Women

The traditional FDA pregnancy risk categories (A, B, C, D, X) have been scrapped in favor of a new labeling mandate called the pregnancy and lactation labeling rule (PLLR). This change has been under consideration at the FDA for nearly 2 years and was brought about by the belief that the old A-X labels were “confusing and overly simplistic”, did not adequately portray risk differences and tended to minimize discussion between physician and patient about the risks if taken during pregnancy or lactation.

The FDA undertook this change to “to include relevant clinical information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation.”  The new labeling will fall under sections 8.1-8.3 of the package insert and will contain info on the drug risk summary, clinical considerations and available data, including information regarding pregnancy registries for that product.  Section 8.2 must contain information on breast feeding, drug in breast milk drug levels and the effects of the drug on the infant. Lastly, section 8.3 will have data on pregnancy testing, recommendations on contraception and infertility information.

The new rule, which went into effect on 12/14/14, has adopted the requirement for the above narratives and data to more adequately portray maternal-fetal risks to assist patient-physician communication on these matters. The PLLR will require physicians to read more if they wish to know more on drugs and pregnancy.
-- Jack Cush, MD


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The author has no conflicts of interest to disclose related to this subject