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9 Clinical Experience in Children
Table 9.3. Long-term study with tacrolimus ointment: incidence of
adverse events [14]
Adverse Event1
Frequency [%] (n=255)
Skin and appendages
Skin burning
25.9
Pruritus
23.1
Herpes simplex
5.1
Skin erythema
9.0
Skin infection
11.4
Folliculitis
2.0
Body as a whole
Allergic reaction2
15.3
Flu syndrome
34.5
Infection
7.8
Fever
17.6
Accidental injury
10.6
Nervous system
Headache
18.0
Other
Asthma
16.1
Cough worsened
14.5
1
2
Only skin burning and pruritus were considered to be treatment-related.
Includes food allergics, allergies to grass, cats, etc.
frequency of cough and asthma compared with the shorter-duration trials, but these
events were seasonal and entirely within the normal parameters for paediatric patients (Table 9.3). As shown in Fig. 9.9, there was a progressive amelioration of application-site adverse events, while, importantly, no notable increase in the incidence of
any local skin infection was reported.
No abnormal trends were observed for any laboratory parameter during the
course of the long-term study [14], indicating that systemic absorption is minimal
and thus the risk of systemic exposure is negligible.
Recent Long-Term Safety Data
The above data have been confirmed by the results of a recent long-term study [10].
In this open-label, non-comparative, multicentre extension trial, tacrolimus ointment 0.1% was applied twice daily to affected areas. Almost half (46%) of the 391
178