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Copyright 2003 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2003
Lice R Gone (Safe Solutions Inc, Marne, Mich) is available in the United States as a shampoo for the elimination of head lice. The same formulation is available in the United Kingdom as Not Nice to Lice (Safe Solutions UK, Leighton Buzzard, England). We report here 15 cases of severe ocular irritation, including 7 reports of corneal abrasion, secondary to use of this over-the-counter product. Reports were submitted to the National Registry of Drug-Induced Ocular Side Effects and the Food and Drug Administration.
Infestations of head lice can be treated with various agents.1-3 Safe Solutions Inc states on its Web site (http://www.licergone.com) that its Lice R Gone shampoo is "essentially harmless to people" and "totally effective against head lice and their nits." Ingredients from the product label include"purified water, anionic/nonionic surfactant blend, glycerin, enzymes, peppermint oil, and peace of mind."4 The manufacturer states that the protease enzymes present in the shampoo will safely destroy insect exoskeletons.
The 15 case reports are summarized in Table 1. The mean ± SD age of patients suffering adverse reactions was 20 ± 15 years (range, 2-54 years). There were 3 males, 7females, and 5 with sex unknown. Seven subjects' symptoms resolved when they discontinued use of the Not Nice to Lice shampoo (positive dechallenge), and 6 of these subjects' symptoms resolved within 24 hours. All adverse reactions were immediate and included 7 cases of corneal abrasions and 7 separate cases of severe eye irritation. Six patients described severe ocular pain and 6 experienced abnormal vision, with 1 report of blindness (no follow-up data). Six patients instituted immediate irrigation with water, and 1 patient was treated with diphenhydramine hydrochloride. The amount of shampoo used by all patients was per manufacturer instructions.
The 15 case reports of adverse ocular effects reported here should alert clinicians to the possibility of serious ocular complications secondary to use of this over-the-counter preparation. It may not be unusual for eye irritation to occur when a topical solution is used around the eyes (ie, lice shampoo on the head), but it is unusual for the reaction to cause more than transient eye irritation or red eye. Specifically, reports of corneal abrasions are worrisome as patients will need to seek emergent treatment because of severe ocular pain and the risk of a bacterial infection superimposed on the corneal epithelial defect. Corneal abrasions may be due to the proteolytic enzymes present in the shampoo preparation.
Not Nice to Lice is registered as a medical device in the European Union, and Lice R Gone is registered as a medical device by the Food and Drug Administration in the United States. This enzymatic cleaner is "generally regarded as safe" by the Food and Drug Administration and the European Medical Evaluation Agency. Nevertheless, serious adverse ocular effects frequently do not come to the attention of government regulators until a product is marketed to the public, owing to the limited number of subjects exposed during the developmental phase. Although the adverse ocular reaction was immediate in all reported cases, the symptoms resolved within 24 hours in 6 of the 7 subjects for whom data were recorded. There are no dechallenge data (resolution of the adverse reaction when stopping the medication) available in the remaining 8 case reports.
The incidence of these adverse ocular reactions is difficult to predict with the passive data collection method used here. Conclusions about the exact incidence of drug-induced reactions are generally not possible unless costly follow-up with potentially millions of patients is undertaken.5 In general, if an adverse ocular reaction occurs when these products are used, copious irrigation with water is recommended and follow-up with an ophthalmologist should occur if symptoms persist for more than 24 hours. It is suggested that these recommendations be included in the package insert.
All case reports regarding these ocular reactions, as well as any impressions regarding other medications, can be submitted online at http://www.eyedrugregistry.com. Case reports may also be faxed or mailed to the National Registry of Drug-Induced Ocular Side Effects, 3375SW Terwilliger Blvd, Portland, OR 97201 Fax: (503)494-4286.
The authors have no relevant financial interest in this study.
Corresponding author: Frederick W. Fraunfelder, MD, Casey Eye Institute, Oregon Health and Science University, 3375 SW Terwiliger Blvd, Portland, OR 97201 (e-mail: firstname.lastname@example.org).
Fraunfelder FW, Fraunfelder FT, Goetsch RA. Adverse Ocular Effects From Over-the-Counter Lice Shampoo. Arch Ophthalmol. 2003;121(12):1790–1791. doi:10.1001/archopht.121.12.1790
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