Download Ibuprofen is a non-steriodal anti-inflammatory drug with established

11 December 2002
Inclusion of Paediatric Ibuprofen Formulations on the
WHO Essential Drugs List
Introduction
Paracetamol suspension and suppositories are included in the World Health
Organisation Essential Drug List, indicated as an analgesic and antipyretic.
These dosage forms are suitable for use by the paediatric population.
Acetylsalicylic acid is included in the list in 100-500mg tablet and 50-150mg
suppository form. Where licensed, the suppositories may be used for
paediatric use. Ibuprofen is included in the list only in 200mg and 400mg
tablet form as an analgesic and antipyretic. Generally, 200mg ibuprofen is
indicated only in children above the age of twelve years. We believe there is a
sufficient body of evidence to allow the inclusion of paediatric ibuprofen
formulations for paediatric use in the WHO Essential Drugs List.
The following information relates to ibuprofen suspension and suppository and
refers to its global regulatory status and to data comparing the efficacy of
ibuprofen to paracetamol in paediatric use. A comparison to acetylsalicylic
acid has not been included. The use of aspirin in the paediatric population is
limited due to concerns over the association with Reye’s syndrome.
Given the wealth and consistency of data, we would like to progress an
“application” to include the paediatric formulations on the WHO Essential
Drugs List.
Ibuprofen
Ibuprofen is a non-steroidal anti-inflammatory drug with established analgesic,
anti-inflammatory and antipyretic properties. It is a propionic acid derivative
and is licensed for adult and paediatric use in many countries. Ibuprofen was
first approved in the UK in February 1969 and has been one of the most
heavily prescribed non-steroidal anti-inflammatory drugs (NSAIDs) since then.
It was launched in the UK as an over-the-counter (OTC) medicine, Nurofen, in
1983 and is now widely used in self-medication. A switch to General Sales
List (GSL) status in the UK was obtained in January 1996.
A Boots Healthcare International (BHI) paediatric ibuprofen suspension was
first approved as a prescription-only medicine (POM) in the UK in 1989. The
product was launched in 1990 and obtained OTC status in 1994. Appendix 1
lists those countries where BHI have a licensed paediatric ibuprofen product.
Efficacy versus Paracetamol
Fever is one of the most common symptoms in children, responsible for 2030% of visits to the GP or paediatrician. Symptomatic treatment with rapid
onset may be required to avoid discomfort, dehydration and febrile seizures.
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The efficacy of ibuprofen in the treatment of pyrexia has been studied in
comparator and placebo-controlled studies. The comparator most frequently
used is paracetamol. Licensed doses of ibuprofen vary between countries, as
they do for paracetamol. For all licensed doses, ibuprofen has been shown to
be at least as effective as paracetamol in treating fever. There is evidence
that, at some licensed doses, ibuprofen is superior to paracetamol.
As a general analgesic for short-term use, the efficacy of ibuprofen is at least
equivalent to that of paracetamol. In more long-term treatment, ibuprofen has
anti-inflammatory properties which make it a more suitable analgesic than
paracetamol in disorders such as chronic juvenile arthritis.
Safety
The tolerability of ibuprofen when used as a short-term antipyretic/analgesic is
similar to that of paracetamol. A large safety study involving 84,000 children
showed a similar safety profile for ibuprofen and paracetamol (Lesko &
Mitchell, 1995).
The risk of asthma complications in a subset of 1,876 children with asthma
was significantly lower among those children treated with ibuprofen who had
no known sensitivity to this medication, compared to those treated with
paracetamol (Lesko et al, 2002). Furthermore, the wide therapeutic index of
ibuprofen confers an advantageous safety profile in overdose when compared
to paracetamol.
References:
Lesko SM, Mitchell AA
An assessment of the safety of paediatric ibuprofen
JAMA 1995; 273 (12): 929-931
Lesko SM, Louik C, Vegina RM, Mitchell AA
Asthma morbidity after the short-term use of ibuprofen in children
Paediatrics 2002; 109 (2)
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APPENDIX I
Regulatory and Marketing Status in EU countries
Territory
Trade Name
Status
France
Nureflex enfants et
nourrissons
Nureflex enfants et
nourrissons sans sucre
Belgium
Junifen
Junifen suikervrij
Luxembourg Junifen
Junifen suikervrij
Denmark
Nurofen Junior Mikstur
The
Nurofen voor kinderen
Netherlands suikervrije suspensie
United
Nurofen for Children
Kingdom
Nurofen for Children Singles
(sachets)
Greece
Nurofen for Children
Ireland
Nurofen for Children
Germany
Nurofen fur kinder fiebersaft
Portugal
Junifen
Austria
Junifen
Spain
Junifen suspension
Italy
Nureflex Bambini Suspensione
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OTX
Date of
Approval
20.12.93
Date of
Launch
06.94
OTX
11.00
04.02
P
P
P
P
POM
P
13.11.95
09.03.98
05.06.96
30.09.98
05.08.96
15.07.97
12.95
01.99
07.96
01.99
Not marketed
08.99
P
11.03.98
04.98
GSL
12.04.02
POM
P
P
POM
POM
POM
POM
24.09.98
21.12.98
20.04.99
16.10.99
19.10.99
08.03.00
30.08.00
Not yet
launched
Not marketed
03.99
06.99
Not marketed
Not marketed
05.00
26.10.00
Regulatory and Marketing Status in non EU countries
Territory
Trade Name
Status
South Africa
Nurofen Junior Suspension
Botswana
Namibia
Thailand
Saudi Arabia
Philippines
Malaysia
Australia
Russia
Romania
Hong Kong
New Zealand
Hungary
Singapore
Cyprus
Israel
Poland
Czech
Republic
Slovak
Republic
Bulgaria
P
Date of
Approval
01.06.90
Date of
Launch
Unknown
P
OTC
OTC
POM
POM
POM
P
P
OTC
28.06.00
01.06.90
01.06.90
29.03.91
Unknown
04.05.95
05.01.98
03.02.98
06.03.98
Not launched
Unknown
Unknown
04.91
04.93
08.95
07.99
09.99
04.98
OTC
P
P
P
01.08.98
05.09.98
12.03.99
12.03.99
09.98
02.99
04.99
Not launched
POM
OTC
25.05.99
15.09.99
07.99
10.99
POM
OTC
OTC
27.10.99
16.11.99
02.02.00
04.00
Not marketed
04.00
Nurofen for Children
OTC
04.05.00
11.00
Nurofen for Children
POM
05.06.00
Not launched
Nurofen for Children Sugar
Free
Nurofen Junior Suspension
Nurofen Junior Suspension
Junifen
Junifen
Nurofen syrup
Nurofen for Children
Nurofen for Children
Nurofen for children (in
Russian)
Nurofen pentru copii
Nurofen Syrup
Nurofen for Children
Nurofen Szuszpenzio
Gyermekeknek
Nurofen syrup
Nurofen for Children Sugar
Free
Nurofen for Children
Nurofen zawiesina dla dzieci
Nurofen Pro Deti
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