1 / 19

The Risks of Cough/Cold Preparations to Young Children

The Risks of Cough/Cold Preparations to Young Children. Michael Shannon, MD, MPH Children’s Hospital Boston Harvard Medical School. OUTLINE . Principles of Pediatric Drug Safety Relevance to cough/cold preparations Sources of Data

dung
Download Presentation

The Risks of Cough/Cold Preparations to Young Children

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The Risks of Cough/Cold Preparations to Young Children Michael Shannon, MD, MPH Children’s Hospital Boston Harvard Medical School

  2. OUTLINE • Principles of Pediatric Drug Safety • Relevance to cough/cold preparations • Sources of Data • Categories of adverse drug events (ADE) associated with cough/cold preparation use in children • Range of Toxicity

  3. OUTLINE • Principles of Pediatric Drug Safety • Relevance to cough/cold preparations • Sources of Data • Categories of adverse drug events (ADE) associated with cough/cold preparation use in children • Range of Toxicity

  4. OUTLINE • Principles of Pediatric Drug Safety • Relevance to cough/cold preparations • Sources of Data • Categories of adverse drug events (ADE) associated with cough/cold preparation use in children • Range of Toxicity

  5. OUTLINE • Principles of Pediatric Drug Safety • Relevance to cough/cold preparations • Sources of Data • Categories of adverse drug events (ADE) associated with cough/cold preparation use in children • Range of Toxicity

  6. Principles of Pediatric Drug Safety • Extrapolation of adult data to create pediatric doses is fraught with danger • Passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act have been important • The time is now for FDA to begin evaluating agents previously designated “Generally Regarded as Safe”

  7. Toxicity of Cough/Cold PreparationsSources of Data • Poison Centers • Medical Examiner reports • Published Case Reports • FDA • CDC • State and local agencies

  8. Toxicity of Cough/Cold PreparationsSources of Data • Poison Centers • Data from 2001 through 2005 • 328,441 calls to poison centers about children exposed to cough/cold preparations • Includes overdose, interactions and unexpected toxicities • Medical Examiner • 10 deaths in Ohio (J Anal Tox, 2005) • 8 infant deaths from 1999-2005 (J For Sci 2007)

  9. Toxicity of Cough/Cold PreparationsSources of Data • Published case reports • More than 10 published reports of toxicity to young children • Several fatalities • Adverse events included hallucinations, agitation, seizures, and cardiac arrest

  10. Toxicity of Cough/Cold PreparationsSources of Data • Public health authorities • FDA • 27-year analysis of AERS • 401 serious adverse events and 123 deaths • CDC • Reviewed 3 infant deaths in two states (MMWR, Jan 2007) • Over 2 years, 1519 children sent to emergency departments • State and local agencies • 900 calls about children < 5 in one year (Maryland, 2004) • 4 deaths in children under 4 in Baltimore

  11. Categories of Adverse Drug Events • Acute, single overdose • By child • By parent • Chronic overmedication (by parent) • “Therapeutic misadventures” (by parent) • Drug-host interactions • Drug-drug interactions

  12. Categories of Adverse Drug Events • Acute, single overdose • By child • By parent • Chronic overmedication (by parent) • “Therapeutic misadventures” (by parent) • Drug-host interactions • Drug-drug interactions

  13. Categories of Adverse Drug Events • Acute, single overdose • By child • By parent • Chronic overmedication (by parent) • “Therapeutic misadventures” (by parent) • Drug-host interactions • Drug-drug interactions

  14. Categories of Adverse Drug Events • Acute, single overdose • By child • By parent • Chronic overmedication • Therapeutic misadventures • Drug-host interactions • Drug-drug interactions

  15. Range of Toxicity • Cardiovascular • Hypertension • Tachyarrhythmias • Cardiomyopathy • Cardiac Arrest • Neurologic • Neurobehavioral (hallucinations, agitation, psychosis) • Seizures • Metabolic • Metabolic acidosis • Undefined

  16. Range of Toxicity • Cardiovascular • Hypertension • Tachyarrhythmias • Cardiomyopathy • Cardiac Arrest • Neurologic • Neurobehavioral (hallucinations, agitation, psychosis) • Seizures • Metabolic • Metabolic acidosis • Undefined

  17. Range of Toxicity • Cardiovascular • Hypertension • Tachyarrhythmias • Cardiomyopathy • Cardiac Arrest • Neurologic • Neurobehavioral (hallucinations, agitation, psychosis) • Seizures • Metabolic • Metabolic acidosis • Undefined

  18. Range of Toxicity • Cardiovascular • Hypertension • Tachyarrhythmias • Cardiomyopathy • Cardiac Arrest • Neurologic • Neurobehavioral (hallucinations, agitation, psychosis) • Seizures • Metabolic • Metabolic acidosis • Undefined

  19. Conclusions • When a treatment is ineffective, its risks - if not zero - will always exceed its benefits

More Related