MedicCast Episode 247

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EMS Tip of the Week:

Pediatric Cough And Cold Meds Revisited with Lisa Booze, PharmD, CSPI

In November of 2008, we did a segment on pediatric cough and cold medicines – their toxicity and information on regulatory actions at that time. I’d like to revisit that subject with some new data.

From 1990 to 2006, as many as 10% of children in the United States were given cough and cold medicines weekly for illnesses and cold-like symptoms. A few years ago, a group of physicians petitioned the Food and Drug Administration to relook at the safety of pediatric cough and cold medicines. What prompted this was the fact that there were more than 60,000 possible poisonings reported to poison centers yearly, coupled with the lack of any data that these products were effective in small children. In 2007, soon after the petition, manufacturers withdrew over-the-counter cough and cold products that were marketed for children less than 2 years old. In 2008, the FDA recommended that cough and cold products not be used at all in children under 2. Also in 2008, manufacturers went further in response to public pressure, and changed the labeling of products to indicate that they should not be used in children less than 4 years old. The FDA supported this action.

A study that was published in Annals of Emergency Medicine in 2009 looked at pediatric fatalities associated with over-the-counter cough and cold meds reported by 5 sources, including poison centers, over a period of at least 20 years (different sources included different time periods), up to the time of the actions taken on these products. There were just 118 deaths in children less than 12 years old that were concluded to be possibly due to cough and cold medicines.  Most of the fatalities were in children less than 2 years of age. Eighty-eight of the deaths involved an overdose of the medicine, and most of the remaining cases involved giving the child more than one product with the same ingredients. Unfortunately, many of the overdoses were when adults gave the children the cough & cold medicines to sedate them or to control their behavior. This sheds a little more light on pediatric fatalities with cough and cold medicines – how many and why they occurred, prior to the regulatory and voluntary actions.

The FDA is reviewing whether to recommend more restrictions on the labeling of over-the-counter cough and cold medicines. Some have raised concerns that placing restrictions on cough and cold medicines for children might actually increase overdoses, hospitalizations and severe outcomes by parents giving their young children products and doses that are intended to be used by older children and adults. So, Dr. Wendy Klein-Schwartz and Dr Suzanne Doyon of the Maryland Poison center along with Dr. David Sorkin of the University of Maryland School of Medicine analyzed poison center data since the recall and limitations took effect to see if this concern is a valid concern. Their research was published in the August 2010 issue of Pharmacoepidemiology and Drug Safety. The authors found that there was a greater than 50% decrease in the rate of cases of therapeutic dosing errors in children less than 2 years old for the 15 months following the withdrawal in October 2007. This time period included a flu season that was more severe than previously, leading one to predict that there would be more cases of parents giving children cough and cold medicines. There was no difference found in the rate of unintentional poisonings, that is when children grab the bottle and drink from it, or in poisonings with these products for any reason in the 2-5 year old age group. This suggests that products were still accessible to toddlers and still were being given therapeutically to slightly older children. So, concerns that restrictions would lead to more harm is not supported.

Lastly, remember that your regional poison center is available 24/7 to assess and recommend treatment for all cough and cold medicine exposures in children.

References:

Dart RC, Paul IM, Bond GR, et al. Pediatric fatalities associated with over the counter (nonprescription) cough and cold medications. Ann Emerg Med. 2009;53:411-417

Klein-Schwartz W, Sorkin JD, Doyon S. Impact of voluntary withdrawal of over-the-counter cough and cold medications on pediatric ingestions reported to poison centers. Pharmacoepidemiol Drug Saf 2010;19:819-824

Maryland Poison Center

CDC: Cough and Colds Medications Information for Parents

Mayo Clinic Children’s Health

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Until next time, Scene safety, BSI!

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2 Responses to Pediatric Cough and Cold Meds Revisited with Lisa Booze and Episode 247

  1. […] this recent episode of the MedicCast to learn more about FDA and manufacturer changes regarding pediatric… for those patients under age […]

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