Impact of the 2017 FDA Drug Safety Communication on Codeine and Tramadol Dispensing to Children

Renny, Madeline H.; Jent, Victoria; Townsend, Tarlise; Cerdá, Magdalena

doi:10.1542/peds.2021-055887

Cited by 3 publications

(2 citation statements)

References 4 publications

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“…However, with time, recommendations for the use of this drug in children have significantly varied. In Europe, tramadol is approved for the treatment of moderate-to-severe pain in children over 1–3 years of age, depending on the country, with restrictions for children after tonsillectomy or adenoidectomy and in those with significant respiratory problems [ 117 ]. In the USA, where the off-label use of the drug remains significant [ 118 ], it is officially not recommended to use tramadol in children <12 years old and in adolescents <18 years old after ear, nose, and throat surgery.…”

Section: Treatment Of Pediatric Painmentioning

confidence: 99%

“…Restrictions to tramadol use are strictly dependent on the potential development of severe adverse events following drug administration. Similar to codeine, tramadol is primarily metabolized by CYP2D6 [ 117 , 118 , 119 ]. This means that in CYP2D6 ultrarapid metabolizers, therapeutic doses of tramadol may lead to very high concentrations of O-desmethyltramadol, the main active metabolite of tramadol.…”

Section: Treatment Of Pediatric Painmentioning

confidence: 99%

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Pain Management in Children Admitted to the Emergency Room: A Narrative Review

Cunico,

Rossi,

Verdesca

et al. 2023

Pharmaceuticals

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Pain is a biopsychosocial experience characterized by sensory, physiological, cognitive, affective, and behavioral components. Both acute and chronic pain can have short and long-term negative effects. Unfortunately, pain treatment is often inadequate. Guidelines and recommendations for a rational approach to pediatric pain frequently differ, and this may be one of the most important reasons for the poor attention frequently paid to pain treatment in children. This narrative review discusses the present knowledge in this regard. A literature review conducted on papers produced over the last 8 years showed that although in recent years, compared to the past, much progress has been made in the treatment of pain in the context of the pediatric emergency room, there is still a lot to do. There is a need to create guidelines that outline standardized and easy-to-follow pathways for pain recognition and management, which are also flexible enough to take into account differences in different contexts both in terms of drug availability and education of staff as well as of the different complexities of patients. It is essential to guarantee an approach to pain that is as uniform as possible among the pediatric population that limits, as much as possible, the inequalities related to ethnicity and language barriers.

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Section: Treatment Of Pediatric Painmentioning

confidence: 99%

Section: Treatment Of Pediatric Painmentioning

confidence: 99%

Pain Management in Children Admitted to the Emergency Room: A Narrative Review

Cunico,

Rossi,

Verdesca

et al. 2023

Pharmaceuticals

View full text Add to dashboard Cite

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Impacts of labelling revisions on pediatric use of codeine: interrupted time-series analysis using the Japanese nationwide claims database

Sakakibara,

Ogino,

Hasegawa

et al. 2024

Drugs Ther Perspect

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Identifying Opioid-Related Pharmacogenomic Variants in High-Risk Hospitalized Infants: A Pilot Study

Barq,

Ourshalimian,

Maggo

et al. 2024

Preprint

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Introduction: Pharmacogenomic (PGx) variants impact the pharmacodynamics and pharmacokinetics of opioids and the brain's reward, cognition, stress, and pain pathways. This study examines the prevalence of PGx variants impacting opioid response among a cohort of high-risk infants. Methods: This retrospective study was conducted at a quaternary children's hospital from 2009-2020. Infants <1y with one or more high-risk condition (congenital heart disease (CHD), medical or surgical necrotizing enterocolitis (NEC), thoracoabdominal surgery, very or extremely low birthweight, hypoxic ischemic encephalopathy, or extracorporeal membrane oxygenation) with exome sequencing were included. Prevalence of opioid-related variants (COMT, DRD2/ANKK1, ABCB1, OPRM1, CYP2B6, CYP2D6) were compared to Ensembl, a database of published genomic cohorts. Results: Overall, 111 high-risk infants were identified (62.2% male, 47.7% Hispanic/Latino, 18.0% premature, and 82.0% CHD). Most underwent surgery (68.2%), with 37.8% undergoing CHD surgery. Overall, 81.1% of infants were homozygous for more than one opioid-related variant(s). Compared to Ensembl, high-risk infants had a significantly higher frequency of homozygosity for ABCB1: rs1045642 (43.6% vs. 18.7%, p<0.001) and rs2032582 (42.7% vs. 15.9%, p<0.001). Conversely, high-risk infants had a lower frequency of homozygosity for COMT: rs4818 (2.7% vs. 10.3%, p<0.001) and OPRM1: rs1799971 (2.7% vs. 7.1%, p<0.001). All infants with surgical NEC (N=5) were homozygous for one or more opioid-related variant. The most common metabolizer phenotypes were intermediate (CYP2B6: 35.5%, CYP2D6: 20.0%) and normal (CYP2B6: 53.9%, CYP2D6: 70.9%). Conclusion: Most high-risk infants carried at least one opioid-related variant, with frequencies that are significantly different from broader genetic cohorts. Larger studies inclusive of intronic PGx variants using ancestrally comparable controls are needed.

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Impact of the 2017 FDA Drug Safety Communication on Codeine and Tramadol Dispensing to Children

Cited by 3 publications

References 4 publications

Pain Management in Children Admitted to the Emergency Room: A Narrative Review

Pain Management in Children Admitted to the Emergency Room: A Narrative Review

Impacts of labelling revisions on pediatric use of codeine: interrupted time-series analysis using the Japanese nationwide claims database

Identifying Opioid-Related Pharmacogenomic Variants in High-Risk Hospitalized Infants: A Pilot Study

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