Adverse events (AEs)
No AE was observed during the initiation of treatment, in both
conventional and rapid protocols.
We did not find any significant change in the ECG before the initiation
and 3 months after the initiation of Hemangiol® with a PR interval at
115.3±17.6 ms vs. 110.3±19.6 ms (P=0.1), QRS interval at 69.6±11.5 ms
vs. 68.8 ms±12.1 ms (P=0.68), corrected QT interval at 378±20 ms vs.
381±26 ms (P=0.37). No case of atrioventricular block or any other
cardiac adverse event was reported.
During the follow-up, after the initiation period, 25 (26.6%) patients
experienced one or more adverse events. Among these patients, 8 (8.5%)
children presented a SAE: 5 cases of uncontrolled bronchial
hyperreactivity (one associated with pneumopathy and diarrhoea) and 3
cases of serious hypoglycaemia. SAEs led to permanent treatment
discontinuation in 6 cases, temporary discontinuation in one case, and
dose reduction in one case. For all SAEs, causality scores ranged from 2
to 5 out of 6, suggesting possible to strong association between SAEs
and propranolol (Table 3). As recommended by drug agencies, all cases of
SAEs were reported to the national pharmacovigilance centre.
A total of 24 non-serious AEs were reported in 19 (20.2%) patients
(including 2 patients with SAEs and a non-serious AE, and 5 patients
with 2 non-serious AEs): sleep disturbances (N=9), primarily nightmares;
respiratory disorders, especially acute bronchiolitis with temporally
discontinuation of treatment (N=5); and digestive disorders (N=6) with
benign diarrhoea, constipation, vomiting and anorexia. We also found one
suspected case of hypoglycaemia, one case of asthenia, one skin rash,
and one case of repeated disabling sneezing. No non-serious AE required
hospitalization or prolonged drug discontinuation.