WASHINGTON Recent news that the Food and Drug Administration has made decisions regarding the sale of pediatric cough and cold medicines have been premature, according to press statements issued by both the FDA and the Consumer Healthcare Products Association earlier this week.
“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,” stated CHPA president Linday Suydam on Tuesday. “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 [an] upcoming advisory committee meeting,” she said. The meeting Suydam referenced is to take place Oct. 18 and 19.
“The Agency has not reached any final decisions as to actions to be taken in response to a Citizen Petition that requested FDA address the use of … products in children less than 6,” the FDA stated on Monday. “Any review document included in this package [that was posted online] 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.”
Current pediatric labels advise parents to ask a doctor about use of antihistamines for children under 6 years of age. Professional labeling for children between 2 and 6 years of age is available to health providers for the antihistamines. Other products containing decongestants, antitussives (cough suppressants) or expectorants are not labeled for children less than 2 years of age.
“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,’” Suydam said. “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.