OTC cough and cold drug products lack supportive efficacy and safety data
Use a nasal saline drop or spray for congestion and acetaminophen or ibuprofen for fever
The common cold season is here, and if you have children, you will likely feel their suffering from these annoying upper respiratory tract viral infections.
Children experience more colds, about six to 10 annually, than adults. With each cold producing symptoms of nasal congestion, runny nose, cough and mild fever lasting up to seven to 10 days, it may seem that children are nearly continuously sick.
Parents certainly want their ill children to feel better, and they, naturally, want to help. A frequent solution is over-the-counter (OTC) drugs, which are heavily advertised to treat many maladies, including colds. A stroll down your local pharmacy OTC drug aisle will highlight the numerous OTC drug products available for adults and children.
It is tempting to buy one or more of these products to help your child. However, for children younger than 12 years of age, it is best not to use commonly advertised OTC cough and cold drug products. These products lack supportive clinical study efficacy and safety data, an issue I’ve studied as a professor of pharmacy practice.
Children are not just small adults
When treating children with OTC or prescription drugs, it is important to understand that young children differ significantly from the adult population with respect to drug efficacy and adverse effects.
Over the past 30 years, we have learned much more about pediatric pharmacology and drug action and behavior, known as pharmacokinetics, and differences compared to adults. Prior to this, and even today to some extent, health care professionals assumed that drugs functioned and behaved similarly in children as in adults.
Based on this assumption, health practitioners often only reduced the amount of a drug to a child based on a proportion of the child’s body weight to an adult. For example, a provider would prescribe 50 percent of an adult drug dose for a child with 50 percent body weight of an adult. The efficacy of OTC cough and cold product active ingredient, as demonstrated in adult studies, was assumed to be similar in children.
However, we have learned, and are continuing to learn, that this strategy is not accurate and can be dangerous. Most drugs are not specifically studied and evaluated in children prior to their labeling by the FDA and availability to the public.
A safe and effective drug dose and dose schedule (how often a drug dose is given) is derived from these formal studies and evaluations. But without these formal studies, pediatric-specific drug pharmacology is not accurately evaluated and determined. In addition, a physician can legally prescribe any drug for a child, even if there aren’t data supporting its efficacy and safety in children.
OTC drugs regulated differently than Rx drugs
FDA regulation of OTC drug products differs from prescription drug regulation. Active ingredients in OTC drug products are evaluated and approved by therapeutic category, such as the cough and cold therapeutic category. In a major undertaking begun in 1972, the FDA has been reviewing OTC drug product categories for safety and efficacy, and it continues to do so.
Pediatric OTC cough and cold products have seen significant regulatory changes in recent years. In 2007, several health care experts petitioned the FDA to carefully review pediatric efficacy and safety data of OTC cough and cold products, requesting that these products be specifically labeled not for use in children younger than six years of age.
In 2008, the FDA recommended that OTC cough and cold products not be given to children younger than two years old. The trade group representing OTC drug product manufacturers, the Consumer Healthcare Products Association, additionally announced that these products would be labeled “not for use” in children younger than four years old. The FDA agreed, and this remains the current status of pediatric age labeling for OTC cough and cold products.
In addition, reviews of the medical literature indicates that OTC drug ingredients are actually ineffective in reducing cold symptoms in children. OTC cough and cold products can be dangerous to use as well, with more than 100 deaths of infants and young children described in published reports where these products were the sole cause or important contributive causes.
Although several doses of pediatric OTC cough/cold products are unlikely to be toxic, these reports have described scenarios where the products were used inappropriately, by administration of doses too large, doses given too frequently, measurement of liquid doses inaccurately (too much) or administration of similar active ingredient drugs given from numerous OTC products resulting in accumulative large doses.
These mistakes were easily made by parents, considering the difficulty in accurately measuring out small liquid doses and a desire for the drugs to help (more is better).
A word of caution regarding codeine
Recent studies and recommendations have significantly altered our use of another drug historically used to treat cough in children – codeine. It is an opioid, and it is still available over the counter in some cough medicines in some states. It is available in all states as prescription products.