Safety of mRNA-based COVID-19 vaccination in paediatric patients with a PEG-asparaginase allergy.

Background: Children treated for a malignancy are at risk to develop serious illness from a COVID-19 infection. Pegylated asparaginase (PEG-asparaginase) is used in the treatment of acute lymphoblastic leukemia. Allergy to this drug is common and both asparaginase and polyethylene glycol (PEG) are identified as possible antigens.

Vitamin A intake and serum retinol levels in children and adolescents with cystic fibrosis.

Background: Pancreatic insufficient cystic fibrosis (CF) patients receive vitamin A supplementation according to CF-specific recommendations to prevent deficiencies. Whether current recommendations are optimal for preventing both deficiency and toxicity is a subject of debate. We assessed the longitudinal relation between serum retinol levels and appropriate variables.

Vitamin E intake, α-tocopherol levels and pulmonary function in children and adolescents with cystic fibrosis.

Pancreatic insufficiency cystic fibrosis (CF) patients receive vitamin E supplementation according to CF-specific recommendations in order to prevent deficiencies. It has been suggested that higher serum α-tocopherol levels could have protective effects on pulmonary function (PF) in patients with CF. Whether current recommendations are indeed optimal for preventing deficiency and whether vitamin E has therapeutic benefits are subjects of debate.

[Inhaled corticosteroids and behavioural changes in children].

Behavioural changes, such as hyperactivity, aggression, mood swings and agitation may occur during the use of inhaled corticosteroids. Children are particularly vulnerable to this possible adverse drug reaction. As this side effect is reversible, timely recognition is important in order to prevent unnecessary diagnostic investigations and problems at home or at school.

Fever following immunization with influenza A (H1N1) vaccine in children: a survey-based study in the Netherlands.

Background: In November 2009, all children in the Netherlands from 6 months up to 4 years of age were indicated to receive the Influenza A (H1N1) vaccine. Fever is a common adverse event following immunization in children. Pandemrix®, an inactivated, split-virus influenza A (H1N1) vaccine, was used for this age group.

Monitoring adverse events of the vaccination campaign against influenza A (H1N1) in the Netherlands.

Background: In November 2009, a vaccination campaign against Influenza A (H1N1) was started in the Netherlands. The accelerated registration procedure of the vaccines used in this campaign and the use of these vaccines on a large scale indicated a need for real-time safety monitoring.

Objective: To describe the processing, analysing and performing of signal detection by the Netherlands Pharmacovigilance Centre (Lareb) on reports of adverse events following immunization (AEFI) with respect to the two pandemic influenza vaccines, Focetria® and Pandemrix®, used in the Netherlands.

[Omeprazole of limited value in crying babies].

Objective: To determine the role of omeprazole treatment in crying infants under the age of 1 year in whom acid gastroesophageal reflux is suspected and to study the evidence for efficacy, prescribing behaviour and side effects of this medicine, which is not registered for use in infants.

Design: Literature study.

Method: To assess efficacy we conducted a study of the literature using PubMed with the search terms 'gastro-esophageal reflux disease', 'crying', 'adverse drug reactions' and 'omeprazole', in the age category 'all infants 0-23 months' We used the medicine prescription database Interactie DataBase to assess prescribing data and studied reports of suspected side effects of omeprazole in children younger than 1 year to the Lareb Netherlands pharmacovigilance centre.