Frestedt Inc. Supports New NSAID Labeling
October 19, 2020 St. Louis Park, MN
The Food and Drug Administration (FDA) recently published a Drug Safety Communication about nonsteroidal anti-inflammatory drugs (NSAIDs). This communication warns: NSAIDs used during the second half (20 weeks or later) of pregnancy may cause “rare but serious” kidney problems in the unborn baby. The FDA reviews this well-known problem and states: “After around 20 weeks of pregnancy, the unborn babies’ kidneys produce most of the amniotic fluid, so kidney problems can lead to low levels of this fluid. Amniotic fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles develop.” (https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic). NSAIDs such as ibuprofen, diclofenac, naproxen and celecoxib are often used to treat pain and fever.
The FDA is requiring labeling changes to both prescription NSAID labels and over-the-counter (OTC) NSAID Drug Facts Panel labels. These labels must now state NSAID use should be limited between 20-30 weeks of pregnancy due to the risk of fetal kidney problems and low amniotic fluid which may need to be monitored by ultrasound. This change is in addition to past warnings to avoid NSAID use after 30 weeks due to potential fetal heart problems. Also, this warning does not apply to low dose (81mg) aspirin used as directed by a healthcare professional.
Frestedt Incorporated specializes in updates to drug labeling including the pregnancy section of prescription drug labels in accordance with the Pregnancy and Lactation Labeling Rule (PLLR). If your company manufactures NSAID drug products, Frestedt Inc. would be happy to help you navigate and comply with these new label requirements.
Download October 19, 2020 Press Release (PDF Format)