Last spring, a group of pediatricians petitioned the FDA to finally conduct a formal safety review of cough and cold medicines for kids under two years old. [The FDA had resisted for decades in large part because of the longstanding popularity of the drugs. With no scientific basis beyond tradition, they were assumed to be plenty safe. Also, pharmas sell $2 billion of the stuff each year.]
Anyway, the Agency has agreed to conduct a review in October. In the mean time, though, they came out with this announcement:
Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the “Drug Facts” box on the package label.So DON'T give your kid too much medicine, too frequently, and read the labels? Right. Good ideas.
What should parents know about using cough and cold products in children?Wait, what? I know it's just a call to a nurse away, but still, I'm confused.
Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider. [emphasis and ALLCAPS all theirs]
If a government agency that admits to making regulatory decisions without any actual scientific or research basis comes out with a sweeping, stopgap, internally conflicted change of position on cold medicine in August, does it make a credibility problem?
F.D.A. Limits Children’s Cold and Cough Medicines [nyt]
Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children [fda.gov]