Over the Counter (OTC) Children's Cough and Cold Medicines
News
Statement by Commissioner of Health on Cough and Cold Medications
October 7, 2008. Dr. Joshua M. Sharfstein, Commissioner of Health stated:
"Today, manufacturers of cough and cold preparations have announced their intention to stop selling these products for children under age 4. This action is a big step in the right direction and will protect millions of toddlers from these unproven and potentially unsafe drugs. I am proud that Baltimore's pediatric community has led the effort on this issue, starting with a fall 2006 statement to local parents. As the cold season approaches, we still advise that parents not use cough and cold preparations for children under age 6." [October 17th, 2008 Press Release]
October 2, 2008. Dr. Sharfstein Testimony to FDA Part 15 Hearing
Statement on Food and Drug Administration Announcement on Over-the-Counter Cough and Cold Medications for Children
August 22, 2008. Dr. Joshua M. Sharfstein, Commissioner of Health, released the following statement in response to FDA's announcement of a new rulemaking on over-the-counter cough and cold medications for young children:
"The FDA's announcement today is a significant step towards removing unproven and unsafe over-the-counter cough and cold medications for young children from the market. By re-opening the relevant regulation, FDA will hold these products to a modern scientific standard of safety and effectiveness. It is clear that these products cannot meet such a standard today. FDA should move swiftly through this process to protect children.”
"Leading professional organizations, including the American Academy of Pediatrics and the National Association of Pediatric Nurse Practitioners, advise against use of cough-and-cold medications for young children. Manufacturers should respect these professional authorities, recognize the significance of FDA's action today, and voluntarily stop marketing these products to parents of young children as safe, effective, and ‘pediatrician recommended.’”
"As the cold season approaches, parents should save their money and talk to their doctors and nurses about how to make their children comfortable with a cough or cold.”
[August 22nd Press Release] [FDA's Announcement] [Health Department Original Research on Over-the-Counter Cough and Cold Medications Published Since the October 2007 FDA Advisory Statement]
October 18, 2007. FDA Hearing Presentations on Behalf of the Petition:
- Joshua M. Sharfstein, M.D. Commissioner of Health, Baltimore City
- Wayne R. Snodgrass, M.D., Ph.D. University of Texas Medical Branch
- Michael Shannon, M.D., M.P.H. Children's Hospital Boston, Harvard Medical School
- Daniel Levy, M.D., F.A.A.P. President, Maryland Chapter, American Academy of Pediatrics
- Pediatric Adverse Events by Age Range
September 28, 2007. Briefing Information for Joint Meeting of the Nonprescription Druge Advisory Committee & Pediatric Advsory Committee on October 18-19, 2007 Posted
- Dockets Management Page
- Response from Consumer Healthcare Products Association
- FDA Briefing Document
March 1, 2007. Citizen Petition Assigned as Docket Number 2007P-0074/CPI
March 1, 2007. Pediatricians and Public Health Officials Petition FDA, Ask Agency to Stop the Marketing of Over the Counter Cough and Cold Medications for Young Children [Press Release]
October 26, 2006. Baltimore Statement Advises Parents of Young Children Against Use of Over-the-Counter Cough and Cold Preparations [Press Release]
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