Over-the-Counter Cough and Cold Products for Children Under Age 6 Joshua M. Sharfstein, M.D....
Transcript of Over-the-Counter Cough and Cold Products for Children Under Age 6 Joshua M. Sharfstein, M.D....
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Over-the-Counter Cough and Cold Products for Children Under Age 6
Joshua M. Sharfstein, M.D.Commissioner of Health
Baltimore, MarylandOctober 18, 2007
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Background
• 1 year ago next week (October 26, 2006)– 9 chiefs of pediatrics in the Baltimore area– The Maryland Chapter of the American Academy
of Pediatrics– Johns Hopkins pediatrician Dr. Janet Serwint– Baltimore City Health Department
• All joined together to issue an advisory to parents to “not use over-the-counter cough and cold medication for children ages five and under.”
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If so many experts advise against these medications for young
children, why are they so widely marketed and used?
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Widely Marketed
• From July 1, 2006 to June 30, 2007, companies spent more than $51 million advertising over-the-counter pediatric cough and cold medications*
• Marketing themes:– Safe and effective– Pediatricians recommend– Parents can relax
*The Prescription Project, Boston, MA using data from TNS Media
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Parenting, February 2006
“For both babies and big kids, pediatricians recommend Pediacare most. And that makes their Moms feel pretty good, too.”
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American Baby, January 2006
“And like all our Little Remedies cough, cold and fever products, they contain safe, effective, pediatrician recommended ingredients without additives.”
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American Baby, March 2005
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“Mom worries when a cold makes it hard for her kid to breathe. Unless, of course, she has Dimetapp.”
Woman’s Day Magazine
November 1, 2007
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“Nothing is easier to give your infant to get them bouncing around again than the two new formulas of Infant Triaminic Thin Strips.
Triaminic. The Medicine of Motherhood.”
$2 million spent marketing Triaminic infant thin strips in Fiscal Year 2007*
Parenting, November 2006
*The Prescription Project, Boston, MA using data from TNS Media
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Widely Used
Source: Consumer Healthcare Products Association, Submission to FDA, October 2007, p. 9
95 million units of pediatric OTC cough and cold products sold annually
39% of households
44 million buyers
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If so many experts advise against these medications for young
children, why are they so widely marketed and used?
![Page 12: Over-the-Counter Cough and Cold Products for Children Under Age 6 Joshua M. Sharfstein, M.D. Commissioner of Health Baltimore, Maryland October 18, 2007.](https://reader036.fdocuments.in/reader036/viewer/2022062322/56649ce45503460f949b128a/html5/thumbnails/12.jpg)
The Answer: A Gap in Federal Oversight
• FDA did not approve these products on the basis of evidence of safety or effectiveness in children
• FDA has permitted widespread marketing that is not supported by scientific evidence
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History• 30 years ago, a different advisory panel• Start of the OTC monograph for cough and cold
medications• Panel found that evidence in children for these drugs was
“negligible or nonexistent”
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Since 1976
• FDA permitted marketing under classification of “generally recognized as safe and effective” (21 CFR 340.1).
• In recent years:– Doctors report serious injuries and death– Studies fail to show effectiveness in children– Medical authorities express concern
• American Academy of Pediatrics• American College of Chest Physicians• Centers for Disease Control and Prevention
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• To ask FDA to review the data
• To hold these products to an appropriate standard for medicine given to young children
• Over-the-counter cough and cold products for children under age 6 do not meet this standard
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Efficacy
• Wayne R. Snodgrass, M.D., Ph.D.– Professor, Departments of Pediatrics,
Pharmacology and Toxicology• University of Texas Medical Branch
– Chair, Committee on Drugs, American Academy of Pediatrics
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Safety
• Michael Shannon, M.D., M.P.H.– Professor of Pediatrics
• Harvard Medical School
– Chair, Division of Emergency Medicine, Boston Children’s Hospital
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Practical Considerations
• Daniel J. Levy, M.D., F.A.A.P.– President, Maryland Chapter, American
Academy of Pediatrics– In private practice for 30 years– Avid baseball fan