FDA: Kids' Medicines NOT Recommended
Safety experts caution against unsafe and ineffective products.
Oct. 1, 2007 — -- They are widely available in drugstores across the country -- over-the-counter cold and cough remedies, with fruity flavors specifically marketed for kids.
But, there's a growing consensus that these medicines may not always be safe — and for young children, aren't worth the risks.
In a report released last week, safety experts within the Food and Drug Administration said they would recommend NO level of dosage for children under the age of two, "due to the lack of evidence of efficacy and safety concerns."
"There are a variety of problems that can occur, and there have been some deaths associated with cough and cold preparations," says Dr. Janet Serwint, who signed a petition, asking the FDA to warn parents about the dangers of these medicines.
Even more amazing, the industry itself — while insisting its medicines are safe — now agrees they should not be given to very young children.
"Parents should not use these products for children under 2," says Linda Suydam, president of the Consumers Healthcare Products Association.
Suydam says the real problem is "misuse" and "overdose." The labels on most boxes suggest that parents "consult with a doctor" about the appropriate dosage for children under the age of 2. The FDA review called that warning "confusing," and said it appeared to be contributing to "medication errors, which can result in fatal overdoses."
Overall, the review found 54 reported deaths from decongestants over the past four decades, most in children under the age of 2.
Experts say they believe the FDA may finally take action when it meets to discuss the matter next month.
Josslyn Goldner knows how dangerous over-the-counter medication can be. Her son, Max, wound up in the emergency room after he took the prescribed dose of a popular kids' medicine — one that isn't even under FDA review.
She says she has learned to be wary.
"I'm trying to be a little bit more selective and proactive, and not assume that companies that are in the business to make money, are going to actually be worrying so much about my child," Goldner says.