FDA Statement Following CHPA’s Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

On October 7, 2008, the Consumer Healthcare Products Association (CHPA) announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state “do not use” in children under 4 years of age. The association is also introducing new child-resistant packaging and new measuring devices for use with the products.

The FDA supports these voluntary actions to help prevent misuse and to better inform consumers about safe and proper use of these products in children. The FDA will continue to monitor and assess the efficacy and safety of these products and to revise their OTC monographs.  The medications will not be pulled from the market while the labeling updates take place, so the FDA recommends that parents and guardians adhere to the labeling on the current package and ask for assistance from their doctor or pharmacist as this transition takes place.

The FDA has been working to address the safe use of OTC children’s cough and cold medications. A nationwide Public Health Advisory was issued from the FDA in January recommending that these products should not be used in children under the age of two because of the risk for serious or potentially life threatening side effects.

The FDA also works to reach out to other public health agencies, consumer and patient groups, manufacturers, and the CHPA. The FDA will continue to work with the CDC to develop educational materials for parents and consumers for these products.

Until the resolution of the issues pertaining to the relabeling of Children’s cough and cold OTC medication, the FDA has released recommendations for parents and caregivers:

• Do not give children medications labeled only for adults
• Talk to your healthcare professional if you have any questions
• Use OTC products with child-resistant safety caps
• Be aware of the “active ingredients” listed in the DRUG FACTS section of the label
• Use caution if giving a child more than one medication
• Follow the directions on the medication label
• Use only the measuring device that comes with the medication

The CHPA and the FDA promise to work together along with outside experts to reaffirm effectiveness of oral OTC pediatric cough and cold medicines to confirm appropriate dosing and safety.

References:

• www.fda.gov/bbs/topics/NEWS/2008/NEW01899.html
• www.chpa-info.org/10_07_08_PedCC.aspx

Kari E. McDonald, Pharm.D. Candidate