Thursday, 23 Jan 2020

You are here

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

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

Add new comment

More Like This

Best of 2019 - Biologic Safety Guidelines from the British Society for Rheumatology

In the United Kingdom, NICE has looked to the British Society of Rheumatology (BSR) to develop evidence based guidance on the safe use of biologic DMARDs in patients with inflammatory arthritis. This guidance document on biologic safety covers baseline screening, monitoring, effect of co-morbidities, and when or under what circumstances biologic therapy should be interrupted.

Best of 2019 - Methotrexate and the Risk of Lung Disease

Rheumatology has a comprehensive overview of methotrexate (MTX) and the risk of lung injury, MTX-related pneumonitis and interstitial lung disease (RA-ILD) with rheumatoid arthritis (RA). Past reports suggest the frequence of MTX-pneumonitis to be between 0.3 and 11.6%; recent studies suggest it may be much lower.

No Cancer Risk with Systemic Necrotizing Vasculitis

The French Vasculitis Study Group has published that patients with systemic necrotizing vasculitis do not have an increased risk of malignancy; in fact they have a risk that is similar to the general population.

Previous reports have suggested either no risk or a declining risk in the era of better therapies for vasculitis. 

FDA Warns 15 CBD Manufacturers

Today, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).  This warning affirms that the FDA has not determined the many preparations of cannabidiol to be safe or effective.

Biologic Safety Guidelines from the British Society for Rheumatology

In the United Kingdom, NICE has looked to the British Society of Rheumatology (BSR) to develop evidence based guidance on the safe use of biologic DMARDs in patients with inflammatory arthritis. This guidance document on biologic safety covers baseline screening, monitoring, effect of co-morbidities, and when or under what circumstances biologic therapy should be interrupted.