Drug safety: Pregnancy rating classifications and controversies.
This contribution consolidates data on international pregnancy rating classifications, including the former US Food and Drug Administration (FDA), Swedish, and Australian classification systems, as well as the evidence-based medicine system, and discusses discrepancies among them. It reviews the new Pregnancy and Lactation Labeling Rule (PLLR) that replaced the former FDA labeling system with narrative-based labeling requirements. PLLR emphasizes on human data and highlights pregnancy exposure registry information. In this context, the review discusses important data on the safety of most medications used in the management of skin disease in pregnancy. There are also discussions of controversies relevant to the safety of certain dermatologic medications during gestation.
Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
Erin
E
Wilmer
Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
Sandy
S
Chai
Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, Rhode Island. Electronic address: Gk@gkderm.com.
George
G
Kroumpouzos
D000305:Adrenal Cortex Hormones / Q000009:adverse effects; D000890:Anti-Infective Agents / Q000009:adverse effects; D001315:Australia; D001688:Biological Products / Q000009:adverse effects; D000075202:Contraindications; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D007774:Lactation; D004364:Pharmaceutical Preparations / Q000145:classification*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D012176:Retinoids / Q000009:adverse effects; D012871:Skin Diseases / Q000188:drug therapy*; D013548:Sweden; D014481:United States; D014486:United States Food and Drug Administration
D000305:Adrenal Cortex Hormones; D000890:Anti-Infective Agents; D001688:Biological Products; D007166:Immunosuppressive Agents; D004364:Pharmaceutical Preparations; D012176:Retinoids