One year ago, a trade group representing major leaders in the over-the-counter pharmaceutical industry, such as Johnson & Johnson, Wyeth, and Novartis, issued a voluntary market recall of infant formula cold medications. In February 2008, the FDA released a Public Health Advisory recommending no over-the-counter cold medications in children under the age of 2. This month, the over-the-counter pharmaceutical industry once again issued voluntary statements that they will add warning labels to the remaining children’s cold medications – they should not be given to children under the age of 4.
October 2007 Children’s Cold Medication Recall
The recall in Fall 2007 was a preemptive public relations move for an expected Food and Drug Administration (FDA) announcement about the effectiveness of the medications. Research had never been conducted to determine the safety and efficacy of cold medication in children. The dosages had been based on assumptions based on adult figures.
February 2008 FDA Recommendations for Children’s Cold Medication
The questions raised by the panel’s recommendations in 2007 came after a three month investigation and were based on research that found that the cold medications likely have no effect in children. They recommended no medication for children under the age of 2. They also questioned the use of the medications in children under the age of 11, but were not ready to issue guidelines at that time.
October 2008 Doctor Recommendations for Children’s Cold Medicine
This month, the American Academy of Pediatrics asked the FDA to ban children’s over-the-counter cough and cold medication because of insufficient evidence of its benefits, particularly for children 2-6 years of age. The FDA refused due to fears that parents will just give their kids adult medication instead, according to Dr. John Jenkins. The use of adult medication in children has been deadly in the past. Accidental overdoses of acetaminophen and histamine-containing medications have increased in recent years, sending approximately 7000 children in the United States to the emergency room each year.
New Warning Labels for Children’s Cold Medicine
After coming under fire for potentially marketing cold medications for use in children, drug companies issued a statement that they will add warning labels to over-the-counter cold medications stating that they are not to be given to children under the age of 4. Warning labels will be appearing on anti-histamines as well to remind parents that they are not to be given to children to help them sleep. The companies included information for parents in the press release.
The key points for parents to remember are:
- Never give adult medications to a child
- Never give more than one medication that contain the same ingredients or double up on doses
- Speak to a pediatrician about potential treatments or medications prior to giving them
- Follow directions and warning labels exactly
- Keep all medication, over-the-counter and prescription, out of the reach and sight of children
- Remember that the medication will not cure the cold, it only treats the symptoms.
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