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Side effects associated with pharmacotherapy for pediatric irritable bowel syndrome and functional abdominal pain -
Robyn Rexwinkel1, Judith Zeevenhooven1, Faridi S van Etten-Jamaludin2
1a Pediatric Gastroenterology , Emma Children's Hospital, Amsterdam UMC, University of Amsterdam , Amsterdam , The Netherlands.
Insights
Pharmacotherapy for pediatric irritable bowel syndrome (IBS) and functional abdominal pain (FAP-NOS) has limited reported side effects, primarily mild and transient gastrointestinal and central nervous system issues. More high-quality research is needed to confirm safety in children.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
- Evidence-Based Medicine
Background:
- Irritable bowel syndrome (IBS) and functional abdominal pain - not otherwise specified (FAP-NOS) are common in children.
- Pharmacotherapy is used to manage symptoms, but safety data in pediatric populations are limited.
Purpose of the Study:
- To systematically review the literature on the side effects of pharmacotherapy in children diagnosed with IBS or FAP-NOS.
- To assess the safety profile and types of adverse events associated with medications used in pediatric functional abdominal pain disorders.
Main Methods:
- Systematic literature search of Cochrane Library, PubMed, and Embase databases (inception to May 2018).
- Inclusion of randomized controlled trials (RCTs), cohort studies, and case-control studies in children aged 4-18 years.
- Quality assessment of included studies and analysis of reported pharmacotherapy side effects.
Main Results:
- Out of 4619 identified articles, 17 studies met the inclusion criteria.
- Pharmacotherapy side effects were reported in 10/17 (59%) studies, including antispasmodics, antidepressants, antihistamines, serotonergic agents, and antibiotics.
- The majority of side effects were mild, transient, and affected the gastrointestinal tract and central nervous system; no serious adverse events were reported.
Conclusions:
- Data on the safety of pharmacotherapy for pediatric IBS and FAP-NOS are scarce.
- Current evidence suggests that side effects are generally mild and transient, but high-quality research is lacking.
- Further large, well-designed follow-up studies are necessary to establish a comprehensive safety profile.
Introduction:
To systematically review the literature regarding the side effects of pharmacotherapy in children with irritable bowel syndrome (IBS) and functional abdominal pain - not otherwise specified (FAP-NOS). Areas covered: Cochrane Library, PubMed, and Embase databases were searched from inception to May 2018. The following inclusion criteria were applied: (1) randomized controlled trials (RCTs), cohort studies or case-control studies; (2) in children aged 4-18 years or adult studies if children are reported separately; (3) reporting a diagnosis of IBS or FAP-NOS as defined by the authors; and (4) reporting the occurrence of side effects of pharmacotherapy. Quality assessment of included studies was conducted. Expert opinion: A total of 4619 articles were identified; 17 were included. In 10/17 (59%) studies, side effects of pharmacotherapy (antispasmodics, antidepressants, antihistaminic agents, serotonergic agents and antibiotics) occurred. The majority of side effects were: (1) limited to the gastrointestinal tract and central nervous system and, 2) mild and transient. No serious adverse events were reported. This systematic review shows that data on safety in children with functional abdominal pain disorders are scarce, and highlights the lack of high-quality research for potential side effects of pediatric IBS and FAP-NOS. Further research by means of large well-designed-follow-up studies is necessary.
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