September 01, 2011
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Many parents continue to give OTC cold medicines to young children

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In early 2008, the FDA issued a Public Health Advisory for parents and caregivers that recommended not using over-the-counter cough/cold products in children aged younger than 2 years because of a lack of supportive data for efficacy and safety.

Just before the FDA’s recommendations, OTC cough/cold products marketed for infants and children aged younger than 2 years were voluntarily removed from pharmacy and store shelves by manufacturers.

Later in 2008, the Consumer Healthcare Products Association announced that pediatric OTC cough/cold product labeling would be altered (for most available products). The revised indication would state that these products were not recommended for use in children aged younger than 4 years, and the FDA agreed with this labeling change. The FDA is continuing its review of OTC cough/cold product efficacy and safety for children aged 2 to 11 years, and the agency may release additional regulations and recommendations in the near future.

Survey of parents’ beliefs

Although the above information was widely publicized in the lay media and medical literature, several recently published studies and surveys have shown that some parents and health care practitioners are not heeding these recommendations. The most recent data discussed in the lay media related to a survey by the University of Michigan and published online. The CS Mott Children’s Hospital National Poll on Children’s Health surveyed parents (n=349, January 2011) about their attitudes toward, and use of OTC cough/cold products in children aged 6 months to 2 years. Of these parents, 61% stated that they have given their child an OTC cough/cold product within the past 12 months.

Edward A. Bell, PharmD, BCPS
Edward A. Bell, PharmD, BCPS

Parents responding to the use of OTC cough/cold products were also surveyed about their health care providers’ opinions on their use: 57% and 49% reported that they believed their health care providers feel that OTC cough/cold products are safe and effective, respectively. It is not clear whether health care provider was defined in this survey as physicians only, or inclusion of other health care providers.

In another survey, 1,522 adults, of whom 572 were parents of children aged younger than 6 years, were contacted by telephone (National Public Radio, the Henry J. Kaiser Family Foundation, Harvard School of Public Health). This survey was conducted in November 2007, before release of the FDA Public Health Advisory. However, an FDA advisory committee issued its findings on the dangers and lack of efficacy data for OTC cough/cough products in young children in October 2007; 14 products labeled for use in children aged younger than 2 years were voluntarily and quickly removed from store shelves by manufacturers after release of the committee’s report. Sixty-eight percent of parents with children aged younger than 6 years in this survey reported some familiarity with the recently publicized information on pediatric OTC cough/cold products.

When parents with children aged younger than 2 years and children aged 2 years to 6 years were asked about their plans of using OTC cough/cold products in light of the recent FDA findings, 46% and 58%, respectively, reported that they either planned to continue their use or were undecided.

Several months after the release of the FDA’s Public Health Advisory recommending not to use OTC cough/cold products for children aged younger than 2 years, Garbutt surveyed (survey questions were not validated) community pediatricians (n=105) and parents with children aged younger than 12 years (n=1,265) about their attitudes and use of OTC cough/cold products. All of the surveyed pediatricians were aware of the FDA recommendations, with 75% agreeing and 13% disagreeing with them.

Sixty-three percent of the pediatricians surveyed did not recommend OTC cough/cold products for their patients aged younger than 2 years. However, 6% and 29% of pediatricians stated that they would continue to recommend OTC cough/cold products for children aged younger than 2 years and older children, respectively.

Of the parents surveyed, 73% were aware of the FDA recommendations. Of the parents with children aged younger than 2 years, 15% stated that they would continue to give OTC cough/cold products to their younger children, and 61% would continue to give these products to children aged 2 years to 11 years.

Despite the FDA warning about lack of efficacy and potential dangers of OTC cough/cold products for children, 70% of parents agreed that these products comfort their child, and only 32% agreed that they could cause serious and potentially life-threatening adverse effects in young children. An interesting finding from this survey includes the statement that 21% of parents were more likely to request an antibiotic.

Yaghmai published a smaller, but similar survey (February 2008) of pediatricians (n=33) and parents (n=179). Parents were eligible if they had a child aged younger than 6 years. Of surveyed parents with a child aged younger than 2 years, 56% were aware of the FDA’s recommendations, and 66% stated that they would use one of four “name brand OTC cough and cold medications” displayed to the parents (these products were not specified in the published report).

Of those parents aware of the FDA’s recommendations and reporting past use of OTC cough/cold products, 35% stated that they planned to continue to use them for their children. Of the pediatricians surveyed, 78% agreed with the FDA’s recent recommendations, and 94% reported that they would continue not to recommend or would decrease use of OTC cough/cold products for their young patients.

Six percent of pediatricians responded that they would continue to recommend OTC cough/cold products to parents of young children. The small number of surveyed subjects and use of non-validated questions limit this survey.

Parents unaware

In another report, researchers used an online survey instrument to collect information from parents with children aged younger than 6 years (n=377) about their use of OTC cough/cold products and their view of recent FDA actions on these products (Hanoch, 2010). This survey was completed in late 2007, before release of the FDA Public Health Advisory (January 2008). This survey found that 25% of parents with children aged younger than 2 years were unaware of the FDA committee recommendations, despite its coverage in the lay media. Of the parents who were familiar with the recommendations, 32% stated that they planned to continue to use OTC cough/cold products, and 50% reported either questioning or not trusting the FDA committee recommendations.

Conclusions

The surveys and published reports discussed above suggest that some parents may be continuing to give OTC cough/cold products to children. Most of these reports were conducted either before or soon after the FDA Public Health Advisory released in January 2008. With more than 3 years since the release of this advisory, health care providers have now had more opportunities to discuss the potential dangers of using OTC cough/cold products in young children. However, data from the survey conducted in January 2011 by the University of Michigan suggests that some parents are continuing to use these products inappropriately. Although products labeled for and targeted to young children (,2 years) have been taken off pharmacy shelves, parents are likely using OTC cough/cold products labeled for older children.

Action steps

Perhaps it would be wise not to assume that parents are no longer administering OTC cough/cold products to their young children. Ask parents what they are doing and re-educate them about these products — their lack of efficacy data and the potential danger associated with use of these products. Use of saline nose drops, a cool mist humidifier, nasal suctioning and acetaminophen or ibuprofen is much wiser.

For more information:

Edward A. Bell, PharmD, BCPS, is professor of clinical sciences at Drake University College of Pharmacy, Blank Children’s Hospital, in Des Moines, Iowa. Bell is also a member of the Infectious Diseases in Children Editorial Board. Disclosure: Dr. Bell reports no relevant financial disclosures.

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