Postmarketing surveillance study of permethrin creme rinse.

Abstract

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.

Lindane Toxicity: A Comprehensive Review of the Medical Literature

“…Within the category of other central nervous system effects, the most common complaints were tremor, vertigo, paresis, and aphasia (15). There were three cases of shortness of breath, all of which followed labeled usage of lindane, two of these also involved visual changes (18), and the other was an anaphylactic reaction following labeled usage of lindane shampoo (15). Of the three other reactions, there was one case of aplastic anemia (19); one case of leukocytosis, tachycardia, and alopecia (15); and one case of acute generalized exanthematous pustulosis (8).…”

Lice, Nits, and School Policy

“…Although our data are limited by the possible inaccuracy of treatment histories, children whose parents reported treating them before or during follow-up were not less likely to become infested than were children whose parents did not report such treatment. Most pediculicidal agents are safe if used properly, 23,24 but some may cause harm. Central nervous system toxicity and anemia have been reported after exposure to lindane.…”

Relationship of Treatment-Resistant Head Lice to the Safety and Efficacy of Pediculicides

“…No serious adverse events were reported. 15 Permethrin is classified and labeled as a pregnancy category B drug, meaning that fetal risk has not been studied in a population of pregnant women and that animal reproduction studies have shown no fetal risk or that adverse events in animal studies have not been confirmed in human studies. 16…”