According to a study published early online in Pediatrics, the voluntary withdrawal of over the counter (OTC) infant cough and cold medicines in the US has been followed by a reduction in the number of emergency department (ED) visits for adverse events related to these medicines.

In October 2007, the Consumer Healthcare Products Association announced a voluntary market withdrawal of orally administered cough and cold medicines (CCMs) labelled or intended for infants in the US.  This was followed by a recommendation from the US FDA to avoid the use of these products to treat infants and children <2 years of age, as “serious and potentially life-threatening side effects can occur”.  The purpose of this research was to assess whether there have been any changes in the number of ED visits due to CCM-related adverse events since the withdrawal of these products from the OTC market.

National estimates of ED visits for CCM-related adverse events in children aged <12 years for the 14 months before and after the announcement of withdrawal of these products were based on surveillance cases from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance (NIESS-CADES) project.  This project, a collaboration of the CDC, FDA and the US Consumer Product Safety Commission, involves a sample of 63 hospitals in the United States and its territories with a 24-hour ED.

The main findings were as follows:

• The number and proportion of estimated ED visits in children aged <2 years due to CCM-related adverse events almost halved after the withdrawal was announced, from 2,790 visits (28.7%) to 1,248 visits (13.3%), a reduction of 15.4% (95% CI 25.9% to 5.0%).  The contribution of CCMs to the ED visit burden for all medication-related adverse events was also reduced in this age group in the post-withdrawal period, relative to the pre-withdrawal period (reduction of 2.1%; 95% CI 3.8% to 0.4%).

• There was no change in the overall number of estimated ED visits for CCM-related adverse events for children <12 years of age (9727 visits versus 9408 visits).

• During both periods, most of the ED visits involved children aged 2-5 years, and were unsupervised ingestions.  Where medication errors were listed in the ED record, they most commonly involved excess dosing by caregivers (9 of 14 cases pre-withdrawal and 17 of 19 cases post-withdrawal).

• Where symptoms were documented, the most common were described as allergic in nature (57.6% pre-withdrawal and 52.8% post-withdrawal) or as neurological or behavioural manifestations (e.g., somnolence, unsteady gait, irritability, or psychomotor hyperactivity; 42.3% pre-withdrawal and 39.8% post-withdrawal)

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. 

The authors conclude that their findings “demonstrate how public-private collaborative efforts and a combination of education, engineering, and enforcement strategies can be used to improve medication safety in the outpatient setting”.  They discuss further methods that could be used to avoid these adverse events, and comment that future work will be needed to assess the impact of a more recent labelling change to avoid the use of CCMs in children aged <4 years.