Veronica Hackethal, MD
May 05, 2017
The largest surveillance study to date shows over-the-counter cough and cold medicines are generally safe for children younger than 12 years, and adverse events are uncommon. Two-thirds of the adverse events identified were caused by accidental ingestion, researchers report in an article published online May 4 in Pediatrics.
"Although the safety profile garnered by this large surveillance network provides a reassuring comprehensive risk evaluation, additional well-designed efficacy trials of [cough and cold medications] are still needed to conduct a true benefit-risk assessment. Understanding what benefit(s) these medications may provide is essential considering that no medication is without risk," write Jody Green, PhD, from the Rocky Mountain Poison and Drug Center, Denver, Colorado, and colleagues.
The researchers conducted the study as part of the Pediatric Cough and Cold Safety Surveillance System, which was started in 2008 because of safety concerns about use of these medications in children. In response to a citizen petition in 2007, companies began voluntarily relabelling their products to advise against use in children younger than 4 years. In addition, concentrated infant formulations were withdrawn from the market, and the US Food and Drug Administration issued reminders about never using cough and cold medicine in children younger than 2 years.
At that time, however, little evidence existed regarding the safety and effectiveness of cough and cold medication in children.
To fill in the gaps, Dr Green and colleagues analyzed data from the Pediatric Cough and Cold Safety Surveillance System, which uses data from five different data sources and has information on self-reported cases of adverse events. The authors focused on adverse events in children younger than 12 years that occurred after ingestion of one of the following: brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, and pseudoephedrine. An expert panel reviewed the identified cases.
Between 2009 and 2014, 3251 adverse events related to cough and cold medicine occurred. Most were not fatal (99.4%).
Twenty children (0.6%) died, of whom 14 (70.0%) were younger than 2 years. Four deaths involved a dose above the recommended therapeutic level. No deaths involved a therapeutic dose.
Overall, 67.1% of adverse events were associated with accidental, unsupervised ingestion, and 13.0% involved medication errors. The majority of all adverse events happened in children younger than 4 years (59.7%).
Diphenhydramine and dextromethorphan were reported in the majority of cases (58.2% and 38.7%, respectively). Reports of adverse events were also more common after ingestion of single-ingredient products (77.5%).
The authors stressed that more efforts are needed to prevent adverse events after ingestion of cough and cold medicine in children. Such efforts should focus on preventing accidental unsupervised ingestions and medication errors in children younger than 4 years.
The results "suggest that the availability of medication in the home and [cough and cold medicine] storage practices that make the medication accessible to toddlers most often lead to [adverse events,] rather than therapeutic use per se," they write.
Interventions likely to have the greatest effect include child-resistant packaging and flow-restriction devices to help assure proper measuring. Caregiver education about proper storage and supervision is also important. Poison prevention programs also need continued support, according to the authors.
The authors emphasize that the study could not assess efficacy of the drugs.
The study was funded by a grant from the Consumer Healthcare Products Association Pediatric Cough Cold Task Group. One or more authors reports grants, personal fees, and/or royalties from one or more of the following: Consumer Healthcare Products Association Pediatric Cough Cold Task Group, McNeil Consumer Healthcare, Colorado Department of Public Health, Environment Medical Marijuana Scientific Advisory Counsel, UpToDate, Procter & Gamble Company, Pfizer, Zarbees, Inc, and/or Perrigo Nutritionals.