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.