Adverse Events From Cough and Cold Medications After a Market Withdrawal of Products Labeled for Infants
Objective: A voluntary market withdrawal of orally administered, over-the-counter, infant cough and cold medications (CCMs) was announced in October 2007. The goal of this study was to assess CCM-related adverse events (AEs) among children after the withdrawal.
Methods: Emergency department (ED) visits for CCM-related AEs among children <12 years of age were identified from a nationally representative, stratified, probability sample of 63 US EDs, for the 14 months before and after announcement of withdrawal.
Results: After withdrawal, the number and proportion of estimated ED visits for CCM-related AEs involving children <2 years of age were less than one-half of those in the prewithdrawal period (1248 visits [13.3%] vs 2790 visits [28.7%]; difference: −15.4% [95% confidence interval [CI]: −25.9% to −5.0%]), whereas the overall number of estimated ED visits for CCM-related AEs for children <12 years of age remained unchanged (9408 visits [95% CI: 6874–11 941 visits] vs 9727 visits [95% CI: 6649–12 805 visits]). During both periods, two-thirds of estimated ED visits involved unsupervised ingestions (ie, children finding and ingesting medications).
Conclusions: ED visits for CCM-related AEs among children <2 years of age were substantially reduced after withdrawal of over-the-counter infant CCMs. Further reductions likely will require packaging improvements to reduce harm from unsupervised ingestions and continued education about avoiding CCM use for young children. Monitoring of CCM-related harm should continue because recommendations were updated in October 2008 to avoid the use of CCMs for children <4 years of age.
- adverse events
- drug safety
- medication errors
- drug packaging
- nasal decongestants
- antitussive agents
- product withdrawals
- nonprescription drugs
- Accepted August 31, 2010.
- Copyright © 2010 by the American Academy of Pediatrics