Postmarketing surveillance study of permethrin creme rinse.

BACKGROUND: An observational, epidemiological study was undertaken to evaluate the safety of permethrin 1% creme rinse (Nix) for treatment of head lice infestations. METHODS: Thirty-seven local public health departments enrolled a total of 38,160 patients for 47,578 treatments with permethrin or other pediculicides from September 1, 1986, through January 31, 1988. Follow-up safety information was collected between 7 and 14 days following treatment via return visit or telephone contact. RESULTS: One hundred three adverse events were reported among 41,955 evaluable treatments. The rates of reported adverse events were 2.2 per 1000 treatments among permethrin treatments, 3.4 per 1000 treatments among lindane treatments, and 1.5 per 1000 treatments among other over-the-counter treatments. No serious, unexpected adverse events were detected in the 18,950 patients treated with permethrin. CONCLUSIONS: This study confirmed the safety profile of permethrin in conditions of general use, as seen in clinical trials. Postmarketing safety monitoring in public health departments of drugs used to treat public health conditions was shown to be feasible.

Scabies in nursing homes: an eradication program with permethrin 5% cream.

Permethrin 5% cream was used to treat scabies in three large nursing homes under a compassionate-plea protocol for chronic, therapy-resistant infestations. All residents, staff, and frequent visitors were treated whether or not symptomatic. Family members of these groups were treated either when symptomatic or directly exposed to scabies. Nine hundred ninety-five persons were treated, 202 of whom were diagnosed with scabies. Approximately 35% (111 of 313) of nursing home residents were diagnosed with scabies. These were patients in whom multiple treatments with other scabicides were unsuccessful. At the completion of the study, 195 patients were examined for efficacy of treatment. Of these, 91 (46.7%) had clearing of lesions with one medication application, 77 (39.5%) with two treatments, and 23 (11.8%) with three or more treatments. The overall cure rate was 98%. Adverse experiences occurred in 2.4% of cases and were mild (i.e., pruritus and rash).

Comparative study of 5% permethrin cream and 1% lindane lotion for the treatment of scabies.

A multicenter, randomized, investigator-blind controlled trial was conducted to compare the safety and efficacy of a single, whole-body application of 5% permethrin cream with that of 1% lindane lotion for the treatment of scabies in 467 patients. At 14 +/- 3 days after treatment, the mean active lesion count decreased from pretreatment levels of 85 (range, 4 to 600) in both treatment groups to 14 (range, 0 to 133) in the permethrin group and to 15 lesions (range, 0 to 500) in the lindane group. At 28 +/- 7 days after treatment, complete resolution had occurred in 181 (91%) of 199 patients treated with permethrin and in 176 (86%) of 205 patients given lindane. Pruritus due to scabies persisted at 28 +/- 7 days in 14% of the permethrin group and in 25% of the lindane group. The most frequent adverse effects were new or increased pruritus and mild, transient burning or stinging; the latter was slightly more frequent following permethrin treatment and appeared to be related to severity of infestation. Because of a lower potential for neurologic toxicity, permethrin may be preferable to lindane for the treatment of scabies particularly in children.