Adverse Events Down in Infants Following OTC Med Withdrawal

ER visits for adverse events linked to infant cough and cold medications drop by more than half

MONDAY, Nov. 22 (HealthDay News) -- The incidence of adverse events seen in emergency departments that were linked to infant cough and cold medications (CCMs) dropped by more than half soon after the over-the-counter products were withdrawn from the market in 2007, according to a study published online Nov. 22 in Pediatrics.

Nadine Shehab, of the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues assembled data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project for a sample of 63 U.S. emergency departments to assess the effect of the 2007 withdrawal from the market of orally administered, over-the-counter infant CCMs. The researchers looked at the incidence of CCM-related adverse events among children under 12 years of age for the 14 months before and after the announcement of the withdrawal.

Following the withdrawal, the researchers found that the estimated number of emergency department visits for adverse events related to CCMs in children under 2 years of age was less than half of that of the pre-withdrawal period (13.3 versus 28.7 percent), while the same measure remained unchanged for children less than 12 years of age. During both the pre- and post-withdrawal time periods, two-thirds of the estimated emergency department visits involved a child getting into medications and ingesting them without supervision.

"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 less than 4 years of age," the authors write.

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