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Statement from the Consumer Healthcare Products Association on the Safety of Pediatric Over-the-Counter Medicines
Date:10/2/2007

WASHINGTON, Oct. 2 /PRNewswire-USNewswire/ -- Following is a statement by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), in response to inaccurate and misleading media reports surrounding the U.S. Food and Drug Administration's upcoming joint meeting of the Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee scheduled for October 18 and 19:

"CHPA and the makers of pediatric, over-the-counter cough and cold medicines are committed to helping ensure the safe use of cough and cold medicines in children. Our highest priority is the safe use of our medicines.

"Recent media reports have misstated the FDA's position on the use of pediatric cough and cold medicines, and these inaccurate reports may unnecessarily alarm and confuse parents who have successfully relied on these medicines to relieve the cough and cold symptoms in their children for generations.

"FDA has not called for a ban on medicines for children under 6. Rather, the agency has presented a variety of internal and external recommendations for discussion at the upcoming advisory committee meeting.

"FDA's press office issued a note to correspondents yesterday further clarifying that 'the Agency has not reached any final decisions as to actions to be taken in response to a citizen petition ... Any review document included in this package that contains specific recommendations should not be considered final decisions by the Agency. After hearing the recommendations of the advisory committee, FDA will determine the course of action.'

"Parents can continue to trust over-the-counter cough and cold remedies for their children. The instructions on these medications have always clearly directed parents to 'Ask a Doctor' before administering to children under two. We strongly encourage parents to adhere to the recommended dosing instructions for all medicines, recognizing that the vast majority of adverse events associated with their use are due to inadvertent overdosing and misuse. When used as directed, these medicines are safe and effective.

"Based on our commitment to the health and wellbeing of our nation's families, and because children under age 2 are most vulnerable to misuse of over-the-counter cough and cold medicines, we are recommending that labeling for children under 2 be strengthened to read, 'Do Not Use' versus 'Ask a Doctor.' We also are recommending that language be added to the label of OTC antihistamines to read, 'Do not use to sedate children.'

"In the coming months, we'll be launching a major educational campaign alerting parents and caregivers to use great caution when administering medicines to children. Specifically, we will target parents and caregivers of children under two, as well as pediatricians, to further underscore that over- the-counter medicines should not be given to children under two.

"As the makers of over-the-counter cough and cold medicines for children, we remain committed to ensuring parents and caregivers have the information they need to use these medicines safely and effectively, and that they have access to the very best possible medicines for their children.

Editor's note: FDA has posted some recommendations for parents (link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=6 8#8 ) in addition to issuing a note to correspondents further clarifying that no final decision on recommendations has been made.

CHPA is the 126-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.

http://www.chpa-info.org

Contact: Elizabeth Funderburk

202.429.9260 (work)

202.256.5677 (cell)


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SOURCE Consumer Healthcare Products Association
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