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Fewer Adverse Events from Cough and Cold Medicine in Infants and Young Children

Summary and Comment |
December 23, 2013

Fewer Adverse Events from Cough and Cold Medicine in Infants and Young Children

  1. Cornelius W. Van Niel, MD

Withdrawal of infant products and revised labeling have reduced adverse events from supervised ingestions.

  1. Cornelius W. Van Niel, MD

Studies show that cough and cold medications (CCMs) not only are ineffective in young children, but might also cause harm. Manufacturers voluntarily withdrew infant over-the-counter (OTC) CCMs from the market in 2007, and revised labeling in 2008, to discourage use in children younger than 4 years. To determine whether these actions led to a decline in emergency department visits for CCM adverse drug events (ADEs), researchers examined national ADE surveillance data from 2004 to 2011 in children younger than age 12 years. CCMs included OTC (77%) or prescription decongestants, antitussives, analgesics, and antihistamines, and herbal/alternative remedies.

In children younger than 2 years, the fraction of all ADEs caused by CCMs decreased from 4.1% (about 2100 annual cases) before product withdrawal to 2.4% afterward. This reduction was mostly due to a decrease in supervised ingestions of CCMs; unsupervised ingestions accounted for 64% of ADEs following product withdrawal. In children aged 2 and 3 years (the targets of the labeling revision), CCM ADEs declined from 9.5% of all ADEs (about 4100 annual cases) to 6.5%. Nearly 90% of post-revision CCM ADEs were attributed to unsupervised ingestions. Interrupted time series analyses indicated that ADE rates were consistently higher before the changes and lower afterward, suggesting that they were indeed causally related.

Comment

Rates of adverse events from cough and cold medications appear to have been reduced following withdrawal and labeling changes aimed at curtailing use in children younger than 4 years. Preventing unsupervised ingestions will reduce these rates further. The message to lock away even seemingly benign remedies from young children is important.

  • Disclosures for Cornelius W. Van Niel, MD at time of publication Equity Covidien; Express Scripts; Johnson & Johnson; Merck

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