Safety of a topical insect repellent (picaridin) during community mass use for malaria control in rural Cambodia.
BACKGROUND
While community distribution of topical repellents has been proposed as an additional malaria control intervention, the safety of this intervention at the population level remains poorly evaluated. We describe the safety of mass distribution of the picaridin repellent during a cluster-randomised trial in rural Cambodia in 2012-2013.


METHODS
The repellent was distributed among 57 intervention villages with around 25,000 inhabitants by a team of village distributors. Information on individual adverse events, reported by phone by the village distributors, was obtained through home visits. Information on perceived side effects, reported at the family level, was obtained during two-weekly bottle exchange. Adverse events were classified as adverse reactions (events likely linked to the repellent), cases of repellent abuse and events not related to the repellent use, and classified as per Common Terminology Criteria for Adverse Events.


RESULTS
Of the 41 adverse events notified by phone by the village distributors, there were 22 adverse reactions, 11 cases of repellent abuse (6 accidental, 5 suicide attempts) and 8 non-related events. All adverse reactions were mild, occurred in the first few months of use, and mainly manifested as skin conditions. Of the 11 cases of abuse, 2 were moderate and 2 life-threatening. All cases with adverse reactions and repellent abuse recovered completely. 20% of families reported perceived side effects, mainly itching, headache, dizziness and bad smell, but few discontinued repellent use.


CONCLUSIONS
Adverse reactions and abuse during mass use of picaridin were uncommon and generally mild, supporting the safety of the picaridin repellent for malaria control.
National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.|Institute of Tropical Medicine, Antwerp, Belgium.
Somony
S
Heng
Institute of Tropical Medicine, Antwerp, Belgium.|University of Antwerp, Department of Biology, Antwerp, Belgium.
Vincent
V
Sluydts
Institute of Tropical Medicine, Antwerp, Belgium.
Lies
L
Durnez
National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.
Vanna
V
Mean
Banlong Referral Hospital, Ban Lung City, Ratanakiri Province, Cambodia.
Koh
K
Polo
National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.
Sochantha
S
Tho
Institute of Tropical Medicine, Antwerp, Belgium.|University of Antwerp, Department of Biomedical Sciences, Antwerp, Belgium.
Marc
M
Coosemans
Institute of Tropical Medicine, Antwerp, Belgium.
Johan
J
van Griensven
D002160:Cambodia; D004244:Dizziness / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007302:Insect Repellents / Q000009:adverse effects* / Q000627:therapeutic use; D009032:Mosquito Control / Q000379:methods*; D010880:Piperidines / Q000009:adverse effects* / Q000627:therapeutic use; D012424:Rural Population; D016896:Treatment Outcome
D007302:Insect Repellents; D010880:Piperidines; C483506:picaridin