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FDA Comments on Label Changes for Children's OTC Cold Meds

Oct 10, 2008 | Parker Waichman LLP

The Food & Drug Administration (FDA) has commented on the decision by the maker's of over-the-counter (OTC) cold medications to modify the product labels to state  "do not use" in children under 4 years.  In its statement, the FDA says it supports the industry's move, and will continue to investigate the safety and effectiveness of the medications.

The Consumer Healthcare Products Association announcement of  the labeling change came barely a week after an FDA advisory panel met to discuss the safety of OTC children’s cold medicines. At that  meeting, pediatricians had pushed for an all-out ban on children’s cough medicines.  The panelists conceded that there was the little evidence the medicine worked, but worried parents would treat their children with adult drugs if pediatric versions were not available.  They did recommend that the drugs be banned for  children under six, but said children older than 2 could keep taking the medications while studies investigating their safety and effectiveness were being conducted.

Concerns over the safety and effectiveness of children's OTC cold medications were sparked by a 2007 study conducted by the Centers for Disease Control that found the drugs had injured 1,500 children under the age of 2  between 2004 and 2005. A second study by FDA safety reviewers reached similar conclusions. Their research found that from 1969 to 2006, at least 54 children died after taking over the counter decongestants, and 69 died after taking over-the-counter antihistamines.

In October 2007, some drug makers removed infant versions of the medications of the market. The medicines recalled at that time included Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand. Pediacare, Dimetapp and Little Colds brand products were also recalled.

According to the FDA, the latest steps that are being taken by drug makers will not affect the availability of the medicines, but said that this voluntary action will result in a transition period where the instructions for use of some OTC cold medicines in children will be different from others. Because the FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age.

If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, the FDA recommends that they adhere to the dosage instructions and warnings on the label that accompanies the medication. The agency said that caregivers  should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist, the FDA said.

The agency also advised that, until questions regarding the safety and effectiveness of children's OTC cold medicines are resolved, parents and caregivers should also:

  • Choose OTC cough and cold medicines with child-resistant safety caps, when available.
  • Check the "active ingredients" section of the DRUG FACTS label of the medicines.
  • Be very careful when giving more than one medicine to a child. If  giving more than one medicine to a child make sure that they do not have the same type of "active ingredients."
  • Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label.
  • Only use measuring devices that come with the medicine or those specially made for measuring drugs.
  • Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat symptom(s) such as runny nose, congestion, fever and aches and do not shorten the length of time your child is sick.

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