Here's news you'll likely want to pass along to the parents of your youngest patients: FDA officials today issued a public health advisory recommending -- in no uncertain terms -- that over-the-counter, or OTC, cough and cold medicines no longer be used in infants and children younger than 2 years of age. For these young patients, the advisory stated, the possible side effects of such medications can be deadly.
FDA Warns Against Using OTC Cough, Cold Meds in Young Children
Side Effects Can Be Life-threatening
By News Staff
1/17/2008
The FDA based its recommendation on a review of published studies on the overall efficacy of OTC cough and cold drugs, as well as on safety information gleaned from decades of widespread use. The FDA review is ongoing, and agency officials expect to release additional recommendations about use of these drugs in children ages 2 through 11 years "in the near future."
Today's recommendation builds on an advisory issued last August, in which the FDA counseled parents not to use these products in children younger than age 2 years "unless given specific directions to do so by a health care provider." At that time, parents of these young patients were cautioned to ensure that they administered only products clearly labeled as pediatric formulas.
At a joint meeting (9-page PDF; About PDFs) of the FDA's Nonprescription Drugs Advisory Committee and its Pediatric Advisory Committee last October, participants discussed at length the value and reliability of data drawn from studies published on these products, concluding that those studies did not demonstrate efficacy because of various factors, including
Today's recommendation builds on an advisory issued last August, in which the FDA counseled parents not to use these products in children younger than age 2 years "unless given specific directions to do so by a health care provider." At that time, parents of these young patients were cautioned to ensure that they administered only products clearly labeled as pediatric formulas.
At a joint meeting (9-page PDF; About PDFs) of the FDA's Nonprescription Drugs Advisory Committee and its Pediatric Advisory Committee last October, participants discussed at length the value and reliability of data drawn from studies published on these products, concluding that those studies did not demonstrate efficacy because of various factors, including
- study design limitations,
- the relatively few number of studies performed,
- the inadequacy of study sample sizes, and
- the studies were underpowered and measured inappropriate outcomes.
In addition, the 22 committee members voted unanimously that it was inappropriate to extrapolate data on cough and cold indications in the common cold from adult studies to infants and children younger than 2 years. Moreover, they voted 18-4 that even extrapolating such data among different age groups within the childhood population still under review -- that is, among those ages 2 through 11 years -- also was inappropriate.
The current FDA advisory notes that pending conclusion of its review, parents and caregivers using these OTC cold medications in children ages 2 through 11 years should
The current FDA advisory notes that pending conclusion of its review, parents and caregivers using these OTC cold medications in children ages 2 through 11 years should
- check the "active ingredients" section of the product label to avoid using products that include more ingredients than indicated for a child's symptoms,
- exercise added caution if administering more than one such product to a child,
- carefully follow dosing instructions on the product label,
- use only the measuring implements included with the product,
- never use these products to sedate a child and
- contact a health care professional with any questions about using these OTC products.
Meanwhile, the Consumer Healthcare Products Association, or CHPA, which represents U.S. manufacturers and distributors of OTC medications and nutritional supplement products, also today issued a press release supporting the FDA's action. The association noted in its release that its member companies had voluntarily withdrawn the pediatric formulations used in infants and children younger than 2 last October, and added that CHPA had at that time launched an educational campaign for parents and caregivers of young children aimed at answering questions and addressing issues related to these products.
At this time, these OTC cough and cold medications are considered Category I products -- that is, they generally are recognized as being safe and effective. If the FDA decides to require new studies on these products, the agency first would have to rule to recategorize the product ingredients as Category II -- not generally recognized as safe and effective -- and the products' sponsors would have the opportunity to perform the requested studies. If the studies failed to establish efficacy or safety, then those products would be pulled from the U.S. market.
