Responding to the urgings of pediatricians, family medicine doctors, and the FDA’s own outside advisors, the agency acted this week to officially recommend against the use of over-the-counter cough and cold medicines for kids younger than 2 years. In some ways this is a ceremonial, but still important, move – manufacturers of these medicines withdrew their advertisements and labeling for kids under 2 last fall in anticipation of the FDA advisory panel’s recommendation in October, 2007 (see Dr. Rotbart’s GERMBlog posting 10/19/07). Pediatricians have been recommending against these medicines in young kids even longer (see Chapter 8, Germ Proof Your Kids – The Complete Guide to Protecting (without Overprotecting) Your Family from Infections (ASM Press, Washington, D.C., 2008).
The rationale behind this official recommedation is straightforward – the medicines have never been shown to benefit kids in this age group, there are undesirable side effects of the medicines, and accidental overdoses are far too common – the medicines are tasty and easy for kids to snatch off the countertop if parents turn their backs for just a minute.
What’s coming next? I anticipate the FDA will follow advisory panel recommendations and extend the admonition against cough and cold medicines for kids between the ages of 2 and 6 years old. More controversial is the possibility of banning the medicines for all kids under age 11 – the FDA’s outside advisors couldn’t come to consensus on that age group (i.e. kids between 6 and 11 years old).
For more about all over-the-counter medicines for kids’ infections, see Chapter 8 in Germ Proof Your Kids – The Complete Guide to Protecting (without Overprotecting) Your Family from Infections (ASM Press, Washington, D.C., 2008).