Do Not Use Decongestants for Colds in Children Younger Than Age 6

Although colds are usually self-limiting, it is common to use over-the-counter (OTC) medications to help relieve symptoms. However, decongestants should not be given to children younger than age 6 years and should be given with caution in those younger than age 12 years, experts conclude in a review published online in BMJ.

There is no evidence these products alleviate nasal symptoms in young children and there is evidence they cause adverse effects that include drowsiness and gastrointestinal upset, write Mieke van Driel, MD, PhD, head, Primary Care Clinical Unit & Head, Faculty of Medicine, University of Queensland in Australia, and colleagues.

In addition, the use of these drugs has been associated with more serious events, such as convulsions, rapid heart rate, and death, in very young children.

These warnings are not new. A decade ago, the US Food and Drug Administration (FDA) issued a public health advisory that OTC cough and cold products should not be used to treat children younger than 2 years. The agency also stated that they were reviewing the evidence for children aged 2 to 11 years, although it has not issued any firm recommendations on that to date.

"It is important that parents have access to appropriate information about the benefits and harms of nasal decongestants for their children," van Driel told Medscape Medical News.

"This is especially difficult when treatments are available OTC, as such medicines are usually perceived as safe," she said. "Most people don't present to their doctor at the first signs of a cold and will try something they bought at the chemist or supermarket. So this information should be available at the point of purchase."

She reiterated that the FDA has published safety information about use of decongestants in children and products intended for children younger than age 2 years have been removed from the market. Other products have been re-labeled stating that they are not to be used for children younger than age 4 years.

"Although this is an important thing to do, it is not enough, and public awareness may need to be raised by campaigns similar to those aimed at reducing antibiotic use," van Driel said.

Michelle Terry, MD, a pediatrician at Seattle Children's Hospital, Washington, agrees with the authors' conclusions. "There is no evidence that decongestants or antihistamines shorten the duration or significantly improve the symptoms of the common cold in children. Reassuring patients and parents that these illnesses are self-limiting is the preferred therapy offered by pediatricians."

She added that "pediatricians should also review with the parents the potential signs and symptoms of respiratory distress in their children" so that parents know when a cold has become more serious and requires physician attention.

No Evidence of Benefit in Children

In their review, van Driel and colleagues evaluated the evidence for various OTC items intended to relieve the symptoms of common upper respiratory infections.

For adults, they evaluated Cochrane reviews that covered treatments such as decongestants, antihistamines, analgesics, intranasal corticosteroids, herbal remedies, and vitamins and minerals (zinc) for the common cold. One review showed sedating antihistamines were associated with relief of rhinorrhea and sneezing versus placebo, but not nasal congestion, and sedation was commonly reported.

The effects of nonsedating antihistamines in adults were unclear, and there was no effect noted for rhinorrhea or sneezing. There was also no increase in the risk of adverse events in adults compared with placebo.

For young children, though, the situation is more problematic because clinical trial data are lacking. Children younger than age 12 years have the highest burden of common colds, and van Driel and coauthors emphasize that the efficacy and safety data are unavailable for this population.

One Cochrane review found low quality evidence that saline irrigations or drops may be effective and safe in young children, while several small trials have reported contradictory results for the use of decongestants and antihistamines on nasal symptoms and safety in children. Although some products that contain decongestant may improve nasal symptoms in children, safety is unclear, especially in small children.

In both children and adults, none of the other commonly used OTC and home treatments, such as heated humidified air, analgesics, eucalyptus oil, or echinacea, are supported by adequate evidence, they note, although zinc lozenges have been shown to reduce the duration but not severity of cold symptoms in adults.

"Parents will want to do what is best for their children," van Driel said. "If they know that decongestants don't have any proven benefit and may actually cause serious harm, they will make safer choices for their child."

She emphasized that the common cold is a self-limiting illness and that "the immune systems of healthy children are perfectly capable of clearing the infection in the course of up to 10 days."

"Parents need to be informed about the natural course of a cold and educated about the warning signs that warrant assessment by a clinician," she added. "It is important to note though that our review focused on the effectiveness of treatments on bothersome nasal symptoms, such as blocked and runny nose."

Recommendations Still Vary

Shan Yin, MD, MPH, medical director, Drug and Poison Information Center at Cincinnati Children's Hospital in Ohio, pointed out that the recommendations vary depending on where you live.

Health Canada says not to use OTC cough and cold medicines in children younger than 6 years, and it's the same in the United Kingdom, Yin noted. "So that's different from the recommendations in the United States."

As for children between the ages of 6 and 12 years, for which there are no recommendations, Yin noted that it gets a little complicated. "When you look at adult studies, they show that some of these products can be helpful, but not so in children," he said. "But the studies in adults are more robust than in pediatric patients."

In adult studies, for example, objective measures, such as evaluating cough, are used more often. In contrast, the data collected in pediatric trials are more subjective. "With children, they most often ask parents or observers about the symptoms," he said.

In addition, although there have been deaths associated with the use of OTC cold medicines, these are always related to ingesting too high a dose. "We do know that sometimes parents may have trouble figuring out a proper dose, or the label is unclear, or somehow the dose is not correct, and the child gets too much," he said. "Most of these deaths are unintentional, but they happen."

Although there may be some incremental benefit from these products, the risk of an unintentional death outweighs the benefit, he added.

Mika Hiramatsu, MD, a pediatrician in private practice in Castro Valley, California, agrees that for the most part, decongestants and other OTC cold preparations are often not needed in children. "We've seen thousands of small children in the emergency room for overdoses, and they don't work any better than home remedies," she said.

She acknowledges that colds can make people miserable and they just want to be well, and it is difficult for parents to see their children sick. "It's the worst for babies and toddlers because they can't blow their nose," she said. "So we need to do things like use a bulb syringe to get the mucus out, or a steamy shower, nasal irrigation, and elevating the head of the bed."

In terms of treatments, a humidifier can help, and for children older than 1 year, honey has been shown to be helpful for a cough, Hiramatsu explained. "And multiple studies have shown a benefit for chicken soup, but any kind of seasoned hot broth can help."

As far as a cut-off age, she explained that children 8 to 12 years or older have an understanding as to what medicine is for and "it's less likely they are going to drink a bottle and end up in the ER."

Overall, good evidence for the use of these products is lacking, but physicians are going to have varying opinions about their use.

Hiramatsu added that she strongly recommends flu vaccination, which is especially important for young children.

The authors had no support from any organization for the submitted work. van Driel declares payment from IN VIVO Academy to develop materials for an educational program on medication overuse headache supported by a competitive unrestricted grant from Pfizer. Gevaert has declared advisory board membership and paid consultancy with Sanofi and Roche. Terry and Hiramatsu have disclosed no relevant financial relationships.

BMJ. Published online October 10, 2018. Abstract

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