NEW YORK While proponents of banning the use of cough-cold medicines in children argue that there is no clinical evidence that the eight ingredients that comprise more than 90 percent of kids’ cough-cold remedies are safe and effective, the converse also is true. That is, there’s no evidence to suggest that those medicine aren’t generally safe and effective, either.
According to the Consumer Healthcare Products Association, 40 percent of American households—representing 44 million homes—rely on pediatric over-the-counter oral cough-cold medications each year to relieve their children’s cold symptoms and help their children feel better. According to a CHPA poll—76 percent of moms have anecdotally reported that the medicines in question work to relieve their child’s cold symptoms.
To help set the record straight, and possibly validate the anecdotal safety and efficacy of these medicines as used by millions of parents, CHPA has committed to conducting pharmacokinetic and efficacy studies on many of these ingredients, including: brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine and pseudoephedrine.
Once the PK studies have been completed, the industry plans to begin research “to revalidate the effectiveness of these medicines.”
Clinical pharmacokinetic studies are performed to examine the absorption, distribution, metabolism and excretion of a drug in healthy volunteers and/or patients. Data obtained from such studies are useful for the design of subsequent clinical trials. They are also necessary for appropriate analysis and evaluation of the efficacy and safety data obtained in clinical trials.
PK studies for pseudoephedrine, sold behind the pharmacy counter as part of a federal mandate to thwart would-be methamphetamine makers, already have been conducted.
CHPA and its member companies have both publicly and privately asserted a greater emphasis on concern over child safety versus a concern over lost cough-cold products sales, as evidenced by their voluntary actions. “The safety of people who use over-the-counter medicines, especially children, is the No. 1 priority of the Consumer Healthcare Products Association and its member companies, who provide over-the-counter cough and cold medicines for pediatric use,” the association stated. “Parents and families trust that these medicines will help relieve their children’s symptoms and help their children feel better.”
CHPA member companies removed products marketed for use under age two last year, and this year have initiated a label change to advise parents not to use the products in children under age four this year; not for safety or efficacy concerns, but rather due to an increased risk of accidental overdose in children under the age of four—either because parents don’t follow prescribed dosage directions, or because children accidentally accessed and consumed the medicines without their parents’ knowledge.
Through the PK and efficacy studies, CHPA is looking to clarify the safety and efficacy of these medicines in an effort to better communicate appropriate dosing for children and prove that these medicines are indeed effective in relieving children’s cold symptoms.
“The vast majority of parents and caregivers safely administer pediatric over-the-counter cough and cold medicines,” CHPA stated. “However, data … compiled by CHPA suggest that in very rare instances, adverse events due to misuse have occurred when children are given excessive doses of medicine or accidentally ingest it themselves.”
The reason there has been no PK or efficacy studies thus far dates back to the mid-1970s, when the FDA determined that these medicines were generally safe and effective when used according to the label. At that time, over-the-counter cough and cold medicines underwent comprehensive scientific assessments and were reviewed by a panel of experts who worked with the agency regarding every active ingredient to determine the safety and efficacy profile, proper indications and dosing for each medication.
THE INGREDIENTS IN QUESTION: A breakdown of the ingredients, their common uses and some of the more popular pediatric brands containing those ingredients.
Brompheniramine is a first-generation antihistamine indicated for the treatment of symptoms of the common cold and allergic rhinitis, such as runny nose, itchy eyes, watery eyes and sneezing. Brompheniramine is one of the active ingredients in three Wyeth’s Children’s Dimetapp products.
Chlorpheniramine is also a first-generation antihistamine. Chlorpheniramine is one of the active ingredients in several Children’s Tylenol Plus formulations from McNeil Consumer Healthcare, in Procter & Gamble’s Vicks Nyquil—Children’s Cold & Cough, Wyeth’s Robitussin Pediatric Cough & Cold, Long Acting and several Triaminic brands from Novartis.
Dextromethorphan is a cough suppressant, providing temporary relief of cough caused by minor throat and bronchial irritation (as commonly accompanies the common cold. Products containing DXM include McNeil’s Children’s Tylenol Plus, Children’s Sudafed PE and Children’s PediaCare brands, Novartis’ Triaminic, Wyeth’s Robitussin Pediatric, Reckitt Benckiser’s Mucinex for Kids and Delsym brands, P&G’s Vicks Nyquil pediatric formulation and Prestige Brands’ Little Colds family of products.
Diphenhydramine is another first-generation antihistamine. Products containing diphenhydramine include McNeil’s Children’s Benadryl, Children’s Tylenol Plus and Children’s PediaCare and Novartis’ Triaminic.
Doxylamine is an antihistamine not found in any popular children’s cough-cold formulations that, in addition to helping relieve cold symptoms, is more commonly used as a sleep aid in the short-term treatment of insomnia. According to Medline Plus, a service of the U.S. National Library of Medicine and the National Institutes of Health, doxylamine should not be used in children under age 12.
Guaifenesin is an expectorant that often is combined with dextromethorphan, a cough supressant. In normal use this combination is believed to produce fewer, but more productive coughs. Children’s products containing guaifenesin include Reckitt Benckiser’s Mucinex for Kids and Mucinex Junior Strength and Wyeth’s Robitussin liquids.
Phenylephrine, a decongestant, is the ingredient many cough-cold manufacturers used to replace the decongestant pseudoephedrine for their on-the-shelf formulations when PSE was pulled behind the pharmacy counter. Children’s products include McNeil’s Children’s Tylenol Plus, Children’s Sudafed PE, Children’s PediaCare and Children’s Benadryl, Prestige Brands’ Little Colds, Wyeth’s Dimetapp, Novartis’ Triaminic and Reckitt Benckiser’s Mucinex for Kids.
All products containing pseudoephedrine, a decongestant, have been sold behind the pharmacy counter since 2006, when the Combat Methamphetamine Epidemic Act was passed. Consequently, there aren’t many children’s formulations containing PSE besides McNeil’s Children’s Tylenol Plus and Children’s Sudafed and Novartis’ Triaminic.