Benzalkonium chloride as a preservative in nasal solutions: re-examining the data.
Recent studies have suggested that benzalkonium chloride (BKC), an antimicrobial agent used as a preservative in nasal sprays, lacks deleterious effects on the nasal ciliated epithelium. Other data, including recent in vivo findings, suggest that BKC may, in fact, produce adverse clinical effects on human nasal tissue, including the aggravation of rhinitis medicamentosa. Toxic effects have also been reported. In light of the discrepancy between negative results and studies suggesting no safety concerns, we consider the possibility of problems in the design and methodology of some of the studies and in the interpretation of results. Clearly, further research is warranted to clarify the significance of conflicting findings. In the meantime, without conclusive data regarding BKC and the possibility of harmful effects, the use of nasal formulations without BKC might be a reasonable alternative.
Graf
P
P
Department of Otorhinolaryngology, Huddinge University Hospital, Karolinska Institute, Sweden.
D000818:Animals; D001548:Benzalkonium Compounds / Q000009:adverse effects*; D006168:Guinea Pigs; D006801:Humans; D008252:Macaca fascicularis; D009330:Nebulizers and Vaporizers; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D051381:Rats; D012107:Research Design
D001548:Benzalkonium Compounds; D011310:Preservatives, Pharmaceutical