FDA: Kids' Medicines NOT Recommended

LIZ MARLANTES, GREG McCOWN and MARY BRUCE, "FDA: Kids' Medicines NOT
Recommended", ABC News, September 30, 2007,
Link: http://abcnews.go.com/WN/story?id=3672787

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.