National Consumers League


NCL Health Issues

NCL Statement on OTC cough and cold drugs for kids

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NCL has worked for decades to ensure that consumers have the information they need to take their medications safely and effectively, whether over-the-Counter (OTC) or prescription drugs. Through our survey research, we have gained an understanding of consumer behaviors and attitudes toward their medications, including OTC cough and cold medications.

In a public hearing before the Food and Drug Administration (FDA)  on over-the-counter cough and cold medication on October 2, 2008, NCL addressed several of the questions posed in the Federal Register, with an overall emphasis on the need for education of parents and caregivers on the proper use of these medications.

Question #2 – Should cough and cold products for the pediatric population continue to be available OTC, or should they be made available by Rx only?

The National Consumers League defers to the FDA, as the government agency responsible for ensuring the safety and efficacy of our medications, to determine, by using its scientific resources and expertise, if and how these medications are made available. As children get an average of six to ten colds a year, we know that parents and caregivers turn to these medications with some frequency, often in conjunction with their pediatrician, hoping to minimize the pain and discomfort of a child. The widespread use of these medications is just one of the many reasons that we feel whatever the outcome, it will be vital to educate parents and caregivers about the FDA’s decision and the proper use of these medications.

We recognize that the FDA’s decision regarding the availability of pediatric cough and cold medication will impact millions of parents and their daily routines. It is therefore important that the FDA communicate and explain their decision, and what it will mean for parents and caregivers In light of numerous media reports on this issue, parents and caregivers remain confused about when it is safe to use these products. We encourage any decision by the FDA be accompanied by a broad based education campaign, with efforts made to reach non-English speakers and the underserved. Parents, caregivers and teachers, as well as health care professionals from pharmacists to pediatricians to nurse practitioners, must remain informed about what remedies are available, where they might be found, how they work, and all associated risks and benefits.

Question 3 – If the pediatric indications and dosing for cough and cold products were no longer available OTC, would the public use the adult formulations of the TOC monograph products for children, and thus create a greater risk of misuse or overdose?

While many parents and caregivers understand that cough and cold medicines do not cure a cold, many people believe that these medications will help everyone get a better night’s sleep.

In a 2005 NCL study on consumer views on access to cough and cold medication, 90% of the mothers said they rely on OTC cold products somewhat or a lot. Additionally, 90% of respondents in households with children under the age of six stressed the importance of access to cough and cold medication at any time of day. This overwhelming percentage demonstrates the strong desire to have access to remedies for children when they are sick.

We would assume, based on the demand for and popularity of these medications, that parents and caregivers may turn to the adult formulations if pediatric alternatives are only available by prescription. If such a decision is made, the FDA needs to clearly state what parents and caregivers should do and specifically what alternative remedies are available to comfort their child (as well as themselves). The adult medications should be clearly labeled that they are NOT for use in pediatric populations, and that modifying an adult dosage for a child can be disastrous.

Question 6 – What is the most appropriate method for determining pediatric doses that could be used as an alternative to the quarter- and half-dose assumptions used in the monograph? Should products be dosed by age, by weight, or both?

Question 9 – Can measurement errors in dosing be reduced using more standardized measuring devices or alternative dosage forms, and, if so, what is the best way to effect this change?

We again defer to the medical and scientific experts at the FDA to best determine the proper dosages for children. However, we believe that in order to reduce measurement errors, parents and caregivers need to be given the most effective and accurate information regarding dosage recommendations. We must learn more about the reality of measuring and administering these medications, and to learn what information is most important.

Parents and caregivers are frequently dispensing these medications in the middle of the night or when the exact measurement instrument might not be available, sometimes resorting to “desperate calculations,” including use of a kitchen spoon. With the current packaging, variation in dosing cups, and dosage recommendations, it is too easy to administer too much or not enough.

Parents and caregivers need to be informed about the importance of and accuracy associated with weight-based dosing. They should be encouraged to know their child’s weight, BUT we must also recognize the challenges this raises for those who don’t know the weight, as well as those who might face language or cultural barriers to obtaining an accurate weight.

Additionally, using multiple medications can often duplicate ingredients, and may also result in overdoses. OTC labels should more clearly and prominently indicate the key ingredients and presence of multiple active ingredients in products. It also seems appropriate that these packages be made to look more like adult medication through the removal of graphics that would be attractive to children, including pictures of teddy bears, fruit and candy.

We hope to work as a united front with the FDA, pharmacists and pediatricians, consumer groups, and other stakeholders to educate parents and caregivers about the FDA’s decision and the implications it will have on children. We thank the FDA for the opportunity to represent the consumer’s voice today.