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New labeling, packaging for pediatric over-the-counter cough medicine
Product labels will now state: ‘Do not use in children under 4 years of age.’
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The Consumer Healthcare Products Association announced last month that the leading manufacturers of pediatric over-the-counter cough and cold medications will modify their product labels to now state, ‘do not use in children under 4 years of age.’
In addition, the association will be introducing new child-resistant packaging and new measuring devices for these products and for products containing certain antihistamines. New language will be added that warns parents not to use antihistamine products to sedate a child.
“Research shows that dosing errors and accidental ingestions – not the safety of the ingredients themselves when properly dosed – are the leading causes of rare adverse events in young children,” Linda A. Suydam, DPA, president of Consumer Healthcare Products Association, said in a press release. “As a result, the leading manufacturers of oral OTC pediatric cough and cold medicines are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines.”
This announcement came soon after the FDA’s public hearing on OTC Cough and Cold Medications for Pediatric Uses on October 2.
Over the past year, the FDA has held two public meetings where it has heard from various groups, including consumers, to address the safe use of nonprescription OTC cough and cold medicines in children. In January, the FDA issued a nationwide Public Health Advisory recommending that children younger than 2 years not use these products due to risk of serious and life-threatening adverse events. At the most recent meeting on October 2, the FDA announced the steps to revise the monograph for these products.
FDA’s response
“One thing is for certain: We must not give children medication labeled only for adults. When deciding on the right doses for children we need to rely on modern scientific standards,” Andrew C. von Eschenbach, MD, Commissioner of Food and Drugs at the FDA, said in a press release.
The FDA officials said they do not object to these label modifications as the association’s new label change is more cautious than that of the current FDA monograph (originally created in the 1970s), which requires advice and supervision of a physician for use in children younger than 2 years of age.
“We at the FDA support these voluntary actions by [the association] and we are continuing to assess the safety and efficacy of these products. We have taken steps as indicated by our part 15 meeting [on Oct. 2] to revise the OTC monograph for these medications,” Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA, said during the media briefing.
During the transition period of the new label changes, some pediatric cough medicines will be labeled with these new recommendations while others will contain the old label stating that they should not be used in children aged younger than 2 years.
“If parents or caregivers purchase a product that does not have the altered labeling or if they have a product with the old label in their medicine cabinet, they should adhere strictly to the dosage instructions and warnings on the label that they have,” Woodcock said. “They should not under any circumstances give adult medications to children.”
While rulemaking on the existing OTC monograph is ongoing, the FDA recommends the following for parents and caregivers:
- Medications labeled only for adults should not be given to children.
- Any questions regarding use of cough and cold medications in children should be discussed with a child’s health care professional.
- Check the active ingredients section of the drug facts label of the medicine being used to ensure it does not contain the same ingredient that may lead to overdosing.
- If giving a child more than one medication, be cautious.
- Follow the directions carefully on how to use the medicine stated in the Drug Facts part of the label.
- Only use measuring devices that come with the medicine or those specifically made for measuring medications.
- Know that using OTC cough and cold medications do not cure the cold or cough.
The FDA will continue to accept written or electronic comments until Dec. 2, 2008.
“We are proceeding with our rulemaking process to update the existing OTC monograph and this process will afford additional opportunity for more data,” Woodcock said. “We expect additional clinical trials and various studies to be conducted that will further inform our understanding of these medicines in children. This process may take several years to complete, but we may have other transitions or interim steps if we learn more pertinent information during this time.” – by Jennifer Southall
Pediatricians have been using these medications in children of different ages for decades even though they have not been tested in this population. The drug companies even go out of their way to say that they do not have the data to support safety and efficacy and therefore do not recommend using in children under a certain age.
Some of the agents are effective and some are not, but I think it’s sort of up for grabs as how this will affect the behavior in physicians. This may affect the behavior in parents. Parents are somewhat unpredictable, but without actually studying this, only time will tell. Everyone hopes that the new labels will affect behavior and will cut down on the unnecessary use of these types of agents in young kids.
– M. Douglas Baker, MD
Infectious Diseases in Children Editorial Board member
For more information:
- www.fda.gov/bbs/topics/NEWS/2008/NEW01899.html. Last accessed 10/13/2008.