Use Cold and Cough Drugs Cautiously in Children

Now that cold season is in full swing, pharmacists are receiving many questions from families about recommendations for cold and cough products.

Medication safety is extremely critical, especially when it involves children. Accidental ingestion of the antitussive medication benzonatate (Tessalon) by young children has resulted in serious adverse events (AEs), including death.¹ This sheds light on the key role pharmacists play in counseling families about cold and cough medication safety.

The FDA does not recommend the use of OTC cold and cough medications for children younger than aged 2 years, because of the risk of serious AEs.² Products that contain dextromethorphan (Delsym) and guaifenesin (Robitussin) are examples.

In fact, manufacturers voluntarily label OTC cold and cough products with the following statement: “Do not use in children under 4 years of age.”² The American Academy of Pediatrics (AAP) recommends avoiding cold and cough medications in children younger than aged 4 years.³ Children aged 4 to 6 years should only use these products if their pediatricians recommend them.³ The AAP considers cold and cough products safe to use in children aged 6 years and older.³ 

Honey can be a helpful home remedy for managing coughs in children. Pharmacists should educate parents to avoid giving honey to infants younger than aged 1 year, because of the risk of botulism.³ In children aged 1 year and older, 2 to 5 ml of honey can be given as needed.³ Mentholated rub (Vicks) can be used for children aged 2 years and older on the skin over the chest and neck areas.³ Saline nasal spray is an effective and safe option for relieving cold symptoms in children of all ages, and it can easily be found over the counter.⁴ Remind parents to make sure their children are drinking enough fluids. If the air in their home is dry, families can also use humidifiers.³ Parents can have their children sit with them in the bathroom and breathe in the mist from a warm shower to help relieve cold and cough symptoms.

In 2018, the FDA announced required safety labeling changes for prescription cold and cough medications containing codeine or hydrocodone.⁵ These medications should only be used by adults.⁵ These medications have caused respiratory depression in children.⁵

Medication Safety Counseling Pearls

Pharmacists should encourage patients to always read the Drug Facts label on OTC cold and cough products.² This is especially important to ensure that they are not taking multiple products with the same ingredient. The measuring device that comes with the medications should be used to ensure the correct dose is given.² Counsel families not to use household spoons for measuring the medication dose. Pharmacists should also educate families to keep all cold and cough products out of reach and locked away from children after administering the medications. This can help prevent accidental ingestion and poisoning.

Expired cold and cough medications should be disposed of at take-back programs, which can also be found at many local pharmacies.⁶ If patients are unable to dispose of these medications at a take-back program, then they can be disposed of in the household trash.⁶ The medication contents can be mixed in a sealable bag or container with cat litter, coffee grounds, or dirt and thrown in the household trash.⁶

References

1. Kim I, Goulding M, Tian F, et al. Benzonatate exposure trends and adverse events. Pediatrics. 2022; 150(6):e2022057779. doi:10.1542/peds.2022-057779

2. Should you give kids medicine for cough and colds? FDA. October 21, 2021. Accessed December 15, 2022. https://www.fda.gov/consumers/consumer-updates/should-you-give-kids-medicine-coughs-and-colds#:~:text=The%20FDA%20doesn't%20recommend,under%204%20years%20of%20age.%E2%80%9D

3. Coughs and colds: medicines or home remedies? HealthyChildren.org. Accessed December 15, 2022. https://www.healthychildren.org/English/health-issues/conditions/chest-lungs/Pages/Coughs-and-Colds-Medicines-or-Home-Remedies.aspx

4. Gallant JN, Basem JI, Turner JH, et al. Nasal saline irrigation in pediatric rhinosinusitis: a systematic review. Int J Pediatr Otorhinolaryngol. 2018;108:155-162. doi:10.1016/j.ijporl.2018.03.001

5. FDA drug safety communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. FDA. January 22, 2018. Accessed December 16, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-requires-labeling-changes-prescription-opioid-cough-and-cold

6. Where and how to dispose of unused medicines. FDA. April 21, 2021. Accessed December 16, 2022. https://www.fda.gov/consumers/consumer-updates/where-and-how-dispose-unused-medicines