benzyl benzoate burns bad: 415 poison centre adverse
TRANSCRIPT
Benzyl benzoate burns bad: 415 poison centre
adverse reaction reports and counting
Jared Brown, Christopher Johnston New South Wales Poisons Information Centre
Sydney Children’s Hospital Network, Westmead, Australia
References and Further Information 1. Strong M, Johnstone P. Interventions for treating
scabies. Cochrane Database Syst Rev 2007; 18:
CD000320.
2. TGA Database of Adverse Event Notifications. www.
Date accessed: 24 April 2014.
3. Scabies [revised Feb 2009]. In: eTG complete
[Internet]. Melbourne: Therapeutic Guidelines
Limited. Accessed 5 May 2014<etg.hcn.com.au>
Jared Brown, Senior Poisons Specialist (Research and
Audit), NSW Poisons Information Centre, Sydney,
Australia. Email: [email protected]
Discussion
Benzyl benzoate is a cause of
significant pain and distress in
both adults and children
• Since 2000, the Therapeutic Goods
Administration and NPS Adverse
Medicine Events Line only had 5 ADRs
reported in total.
• TGA Database of Adverse Event
Notifications 1975-1999: 46 cases of
mostly skin reactions.
• Topical permethrin for scabies has a
significantly larger market share in
Australia but only 24 cases of ADRs
reported to NSWPIC in the same time
period and 6 reports to TGA.
• Reactions to benzyl benzoate are
grossly underreported through
traditional reporting mechanisms
(consumer, health professional and
pharmaceutical industry)
• PICs are an underutilised public health
surveillance system for ADRs.
• Adequate labelling and counselling for
consumers on appropriate first-line
therapy (ie permethrin)3, correct usage
and possible adverse effects is vital.
• Follow-up of cases would improve
understanding of the ADR duration and
outcomes along with strategies to best
prevent and treat reactions when
benzyl benzoate is indicated.
Results summary
• 415 cases identified
• 390 involved skin reactions
• 38 involved ocular reactions from
accidental contact with eyes after
skin application
• 56% female
• 60% children : 40% adults
• Paediatric cases were evenly
spread over all ages
Disposition at time of call:
• 26 attended hospital
• 26 called an ambulance
• 16 referred to hospital
• 9 referred to general practitioners
• 2 attended general practitioners
Background
• Benzyl benzoate is a topical
treatment for scabies and body
lice.
• The two Australian formulations,
Ascabiol and Benzemul are both
25% concentration, dilution is
recommended prior to use for
children.
• The limited clinical trial data on
its use (10-25% concentration)
suggests similar effectiveness to
permethrin.1
• Dermatological adverse reactions
are reported but were classed as
minor with an incidence of
0-38%. 1
Objective:
To describe the nature and frequency of adverse drug
reactions to topical benzyl benzoate in Australia
Methods
• Retrospective review of calls to NSW
Poisons Information Centre during
1 January 2004 – 31 December 2013.
• NSWPIC takes calls mainly from New
South Wales, Tasmania and the
Australian Capital Territory, and after-
hours calls on a rotating roster from the
remainder of Australia (represents 50%
of national call volume with an annual
call volume of ~105,000).
• Inclusion criteria: Suspected adverse
reactions from therapeutic use of
topical benzyl benzoate.
• Poisons Database search strategy:
Substance code of benzyl benzoate
Free text search for “Ascabiol”,
“Benzemul” or “benzyl” with
“benzoate” Signs and symptoms recorded by
NSWPIC as part of suspected
adverse drug reactions from benzyl
benzoate use (N=415)
Number of adverse drug reactions to topical benzyl benzoate
reported by year and age category to NSWPIC (N=415)
Reaction Number
Burning/stinging sensation
282
Screaming/crying 100
Skin redness 72
Pain 69
Skin irritation 36
Ocular irritation 36
Rash 19
Itch 9
Nausea 4
Skin swelling 3
Skin blistering 2
Dizziness 2
Abdominal pain 2
Welts 1
Fainting 1
Visual acuity decreased 1
Unable to open eyes 1
Facial hair loss 1
Headache 1
Drowsiness 1
0
10
20
30
40
50
60
70
80
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Child
Adult