Codeine Following Tonsillectomy Contraindicated in Children
By HospiMedica International staff writers Posted on 06 Mar 2013 |
A new safety review shows that products that contain codeine should not be used for pain relief following tonsillectomy or adenoidectomy in children, due to a possible risk of serious adverse events.
The warning, issued by the US Food and Drug Administration (FDA; Silver Spring, MD, USA), is based on reports of three deaths and one life-threatening case of respiratory depression published in the medical literature following the use of codeine in children with obstructive sleep apnea (OSA) who underwent tonsillectomy or adenoidectomy. The children were determined to be ultra-rapid metabolizers, genetically susceptible to converting normal doses of codeine into dangerous levels of morphine in the body.
Following the reports, a review of the FDA's Adverse Event Reporting System from 1969 to May 1, 2012, and a physician survey conducted by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS; Alexandria, VA, USA) uncovered a total of 12 deaths and three overdoses associated with codeine use in patients ranging in age from 21 months to 9 years. Eight of the cases involved codeine use after adenotonsillectomy, and three involved a respiratory tract infection. The codeine doses were appropriate in most cases.
“Since these children already had underlying breathing problems, they may have been particularly sensitive to the breathing difficulties that can result when codeine is converted in the body to high levels of morphine,” concluded the FDA advisory. “However, [the new] contraindication applies to all children undergoing tonsillectomy and/or adenoidectomy because it is not easy to determine which children might be ultra-rapid metabolizers of codeine.”
A boxed warning regarding the contraindication will be added to the labels of all codeine-containing products in the United States. The contraindication to codeine use does not apply to other types of pain management in children, although the FDA recommends that codeine should only be used if the benefits are anticipated to outweigh the risks.
Codeine (3-methylmorphine), a natural isomer of methylated morphine, is an opiate used for its analgesic, antitussive, antidiarrheal, antihypertensive, antianxiety, sedative, and hypnotic properties. It is used to suppress premature labor contractions, myocardial infarction (MI), cough suppression, as well as many other uses. Common adverse effects associated with the use of codeine include drowsiness, constipation, euphoria, itching, nausea, vomiting, and others. Rare adverse effects include anaphylaxis, seizure, and respiratory depression.
Related Links:
US Food and Drug Administration
American Academy of Otolaryngology-Head and Neck Surgery
The warning, issued by the US Food and Drug Administration (FDA; Silver Spring, MD, USA), is based on reports of three deaths and one life-threatening case of respiratory depression published in the medical literature following the use of codeine in children with obstructive sleep apnea (OSA) who underwent tonsillectomy or adenoidectomy. The children were determined to be ultra-rapid metabolizers, genetically susceptible to converting normal doses of codeine into dangerous levels of morphine in the body.
Following the reports, a review of the FDA's Adverse Event Reporting System from 1969 to May 1, 2012, and a physician survey conducted by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS; Alexandria, VA, USA) uncovered a total of 12 deaths and three overdoses associated with codeine use in patients ranging in age from 21 months to 9 years. Eight of the cases involved codeine use after adenotonsillectomy, and three involved a respiratory tract infection. The codeine doses were appropriate in most cases.
“Since these children already had underlying breathing problems, they may have been particularly sensitive to the breathing difficulties that can result when codeine is converted in the body to high levels of morphine,” concluded the FDA advisory. “However, [the new] contraindication applies to all children undergoing tonsillectomy and/or adenoidectomy because it is not easy to determine which children might be ultra-rapid metabolizers of codeine.”
A boxed warning regarding the contraindication will be added to the labels of all codeine-containing products in the United States. The contraindication to codeine use does not apply to other types of pain management in children, although the FDA recommends that codeine should only be used if the benefits are anticipated to outweigh the risks.
Codeine (3-methylmorphine), a natural isomer of methylated morphine, is an opiate used for its analgesic, antitussive, antidiarrheal, antihypertensive, antianxiety, sedative, and hypnotic properties. It is used to suppress premature labor contractions, myocardial infarction (MI), cough suppression, as well as many other uses. Common adverse effects associated with the use of codeine include drowsiness, constipation, euphoria, itching, nausea, vomiting, and others. Rare adverse effects include anaphylaxis, seizure, and respiratory depression.
Related Links:
US Food and Drug Administration
American Academy of Otolaryngology-Head and Neck Surgery
Latest Critical Care News
- On-Skin Wearable Bioelectronic Device Paves Way for Intelligent Implants
- First-Of-Its-Kind Dissolvable Stent to Improve Outcomes for Patients with Severe PAD
- AI Brain-Age Estimation Technology Uses EEG Scans to Screen for Degenerative Diseases
- Wheeze-Counting Wearable Device Monitors Patient's Breathing In Real Time
- Wearable Multiplex Biosensors Could Revolutionize COPD Management
- New Low-Energy Defibrillation Method Controls Cardiac Arrhythmias
- New Machine Learning Models Help Predict Heart Disease Risk in Women
- Deep-Learning Model Predicts Arrhythmia 30 Minutes before Onset
- Breakthrough Technology Combines Detection and Treatment of Nerve-Related Disorders in Single Procedure
- Plasma Irradiation Promotes Faster Bone Healing
- New Device Treats Acute Kidney Injury from Sepsis
- Study Confirms Safety of DCB-Only Strategy for Treating De Novo Left Main Coronary Artery Disease
- Revascularization Improves Quality of Life for Patients with Chronic Limb Threatening Ischemia
- AI-Driven Prediction Models Accurately Predict Critical Care Patient Deterioration
- Preventive PCI for High-Risk Coronary Plaques Reduces Cardiac Events
- AI Diagnostic Tool Guides Rapid Diagnosis and Prediction of Sepsis