An overview of upcoming changes in pregnancy and lactation labeling information;Revisión de los próximos cambios en la información sobre medicamentos en embarazo y lactación

Pharmacy Practice

Volumn 13, Issue 2, 2015, Pages 1-4

  Mosley, Juan F ^a   Smith, Lillian L ^a   Dezan, Megan D ^a  

^a FLORIDA A AND M UNIVERSITY   (United States)

Author keywords

Drug labeling; Lactation; Pregnancy; United States; United States Food and Drug Administration

Indexed keywords

PARACETAMOL; THALIDOMIDE;

BREAST FEEDING; DRUG CONTROL; DRUG LABELING; DRUG MARKETING; FETUS DISEASE; HUMAN; LACTATION; MATERNAL DISEASE; MEDICAL DECISION MAKING; MEDICAL INFORMATION; NAUSEA AND VOMITING; PREGNANCY; REVIEW; RISK BENEFIT ANALYSIS;

EID: 84931834058     PISSN: 1885642X     EISSN: 18863655     Source Type: Journal    
DOI: 10.18549/PharmPract.2015.02.605     Document Type: Review

References (6)

1. Department of Health and Human Services. Food and Drug Administration. 21 CFR Part 201. Content and Format of Labeling Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. Published 12/04/2014. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf (accessed March 20, 2015).
2. Centers for Disease Control and Prevention. Treating for Two: Data and Statistics. Updated: February 19, 2014. Available at: http://www.cdc.gov/pregnancy/meds/treatingfortwo/data.html (accessed March 20, 2015).
3. Ramoz LL, Patel-Shori NM. Recent Changes in Pregnancy and Lactation Labeling: Retirement of Risk Categories. Pharmacotherapy. 2014;34(4):389-395. doi: 10.1002/phar.1385
4. Food and Drug Administration. Kefauver-Harris Amendments Revolutionized Drug Development. Published October 2012. Available at: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM322886.pdf (accessed March 20, 2015).
5. Aschenbrenner DS. Drug Watch: The FDA Proposes Revisions to Pregnancy Information in Drug Labeling. Am J Nurs. 2008;108 (11):32-34.
6. U.S. Food and Drug Administration. Promoting your health. Pregnancy and Lactation Labeling Final Rule. Published 12/3/2014. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm (accessed: March 20, 2015).