Last reviewed: April 2018
Last updated: January  2018

US FDA warns against using cough and cold medicines containing opioids in children

Cough and cold medicines containing codeine or hydrocodone must not be prescribed to children because the risks outweigh the benefits, according to a safety announcement by the US Food and Drug Administration (FDA). The FDA is encouraging doctors to reassure parents that most childhood coughs and colds are self-limiting and do not need treatment.

Cough and cold medicines containing opioids can still be prescribed for adults. But warning labels will be added to these medicines highlighting the risks of misuse, addiction, breathing problems, overdose, and death.

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Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • presence of risk factors
  • acute onset
  • rhinitis
  • sore throat
  • sneezing
  • post-nasal drainage/drip
  • cough
  • fever
  • non-specific red pharynx
  • nasal mucosal oedema/erythema
  • purulent drainage in nares and posterior pharynx
  • pulse <100 bpm; no hypotension
Full details

Other diagnostic factors

  • malaise
  • myalgia
  • halitosis
  • inflamed tonsils
Full details

Risk factors

  • exposure to affected individuals
  • young age
  • winter season
  • day care attendance
  • exposure to cigarette smoke or other respiratory irritants
Full details

Diagnostic investigations

1st investigations to order

  • no initial test
Full details

Investigations to consider

  • FBC
  • throat swab
  • sputum culture
  • heterophile antibody test
  • CRP
  • CXR
  • sinus CT scans
  • viral testing
Full details

Treatment algorithm

ACUTE

all patients

Contributors

Authors VIEW ALL

Professor

Department of General Practice and Primary Health Care

University of Auckland

Auckland

New Zealand

Disclosures

BA is an author of a number of references cited in this monograph.

Associate Professor of Integrated Care

Department of General Practice and Primary Health Care

University of Auckland

Auckland

New Zealand

Disclosures

TK is an author of a number of references cited in this monograph.

Peer reviewers VIEW ALL

Senior Research Fellow

Division of Community Health Sciences

St. George's University of London

London

UK

Disclosures

CC declares that he has no competing interests.

Professor

Faculty of Health Sciences and Medicine

Bond University

Queensland

Australia

Disclosures

CDM declares that he has no competing interests.

Associate Professor

Department of General Practice and Primary Health Care

Ghent University

Belgium

Disclosures

ADS declares that she has no competing interests.

Mary Lowell Leary Endowed Professor

General Internal Medicine

Paediatrics

Mayo Clinic

Rochester

MN

Disclosures

GP has no competing interests in regards to the common cold. He does consult with a variety of manufacturers and performs research studies related to influenza, founded by vaccine manufacturers, none of which involves virus related to the common cold.

Professor of Clinical Medicine

Albert Einstein College of Medicine

Director

Intensive Care Unit

Weiler Division/Montefiore Medical Center

Bronx

NY

Disclosures

PD has served as a consultant to Reckitt Benckiser, Procter & Gamble, Wyeth Pharmaceuticals, Novartis, Glaxo SmithKline, and Boehringer Ingelheim.

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