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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

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The Risks of Cough/Cold Preparations to Young Children

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  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

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