L L Bio1, J J Cies2. 1. Inpatient Pharmacy Department, Lucile Packard Children's Hospital Stanford, Palo Alto, CA, USA. 2. The Center for Pediatric Pharmacotherapy LLC, Pottstown, PA, USA.
Abstract
OBJECTIVE: To determine the presence of pregnancy warnings on over-the-counter (OTC) dermatologic products with hydroquinone, a potentially harmful ingredient. STUDY DESIGN: Data were obtained from the Food and Drug Administration National Drug Code Directory and Label Repository to identify OTC dermatologic products containing hydroquinone. Products were stratified based on pregnancy or general warning presence (WP) or absence (WA). Product characteristics were compared between groups: hydroquinone concentration, presence of external packaging, indication and warning statements. RESULTS: Of the 112 products studied, 21 had a pregnancy warning and 3 included a general warning against use: WP (n=24) and WA (n=88) group. External packaging was more prevalent in the WP group compared to WA (62.5% vs 29.5%, P=0.004). CONCLUSIONS: Majority of OTC dermatologic products containing hydroquinone did not have a pregnancy warning. This highlights the need for improved labeling and informs providers caring for pregnant women of OTC labeling limitations.
OBJECTIVE: To determine the presence of pregnancy warnings on over-the-counter (OTC) dermatologic products with hydroquinone, a potentially harmful ingredient. STUDY DESIGN: Data were obtained from the Food and Drug Administration National Drug Code Directory and Label Repository to identify OTC dermatologic products containing hydroquinone. Products were stratified based on pregnancy or general warning presence (WP) or absence (WA). Product characteristics were compared between groups: hydroquinone concentration, presence of external packaging, indication and warning statements. RESULTS: Of the 112 products studied, 21 had a pregnancy warning and 3 included a general warning against use: WP (n=24) and WA (n=88) group. External packaging was more prevalent in the WP group compared to WA (62.5% vs 29.5%, P=0.004). CONCLUSIONS: Majority of OTC dermatologic products containing hydroquinone did not have a pregnancy warning. This highlights the need for improved labeling and informs providers caring for pregnant women of OTC labeling limitations.