Drug use and upper gastrointestinal complications in children: a case-control study

Abstract

ObjectiveTo evaluate the risk of upper gastrointestinal complications (UGIC) associated with drug use in the paediatric population.MethodsThis study is part of a large Italian prospective multicentre study. The study population included children hospitalised for acute conditions through the emergency departments of eight clinical centres. Patients admitted for UGIC (defined as endoscopically confirmed gastroduodenal lesions or clinically defined haematemesis or melena) comprised the case series; children hospitalised for neurological disorders formed the control group. Information on drug and vaccine exposure was collected through parental interview during the children's hospitalisation. Logistic regression was used to estimate ORs for the occurrence of UGIC associated with drug use adjusted for age, clinical centre and concomitant use of any drug.Results486 children hospitalised for UGIC and 1930 for neurological disorders were enrolled between November 1999 and November 2010. Drug use was higher in cases than in controls (73% vs 54%; p<0.001). UGICs were associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) (adjusted OR 2.9, 95% CI 2.1 to 4.0), oral steroids (adjusted OR 2.9, 95% CI 1.7 to 4.8) and antibiotics (adjusted OR 2.3, 95% CI 1.8 to 3.1). The duration of use of these drug categories was short (range 1–8 days). Paracetamol showed a lower risk (adjusted OR 2.0, 95% CI 1.5 to 2.6) compared to ibuprofen (adjusted OR 3.7, 95% CI 2.3 to 5.9), although with partially overlapping CIs.ConclusionsNSAIDs, oral steroids and antibiotics, even when administered for a short period, were associated with an increased risk of UGIC.

The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy

“…The most frequently reported therapeutic main group of drugs in previous European studies were antibiotics [18,34,35]. We instead found that vaccines (hexavalent, anti-pneumococcal, anti-meningococcus, trivalent measles/mumps/rubella) were those most commonly reported, in line with another observational survey [18,[36][37][38]. This finding may be explained by different prescription patterns in the various countries, the recent Italian governmental programs aimed at fostering the immunization coverage in the general population and the fact that in Italy the reporting of ADRs related to vaccines, at variance with other drugs, is compulsory [39].…”

Adverse drug reactions in paediatric patients in a tertiary care hospital in India: a prospective observational single centre study

“…5,28,29 At an antipyretic dose, it may cause skin rash, respiratory and gastrointestinal effects including haematemesis. 27,30 Drotaverine and dicyclomine caused minor reactions. Antispasmodic drugs used in children for overactive bladder are usually oxybutynin and tolterodine.…”

Stevens-Johnson Syndrome Associated with Drugs and Vaccines in Children: A Case-Control Study

“…Since 1999 an active surveillance aimed at ascertaining the role of drugs and vaccines in the occurrence of specific acute conditions responsible for the hospitalization of paediatric patients has been conducted in Italy [13], [14], [15]. Non-infective muco-cutaneous diseases were among the conditions included in the surveillance and we focused on cases of SJS and TEN to contribute further information on the causal role of drugs and vaccines.…”