by James Hubbard, M.D., M.P.H.

The FDA met to look at evidence, take comments and decide whether there should be a ban on children’s cough and cold medicine under the age of 6.  They acknowledged the evidence from pediatricians that it was not effective at that age and sent thousands of kids to the ER each year.  Then they punted.  No ban or recall.

A spokesperson for the FDA acknowledged there was no evidence that the meds worked under 6  (apparently the meds were “grandfathered” by the FDA many years ago with no tests on children), but was afraid that parents would use stronger adult meds on children if there was a ban.  The American Academy of Pediatrics does not recommend the meds under 6 and an independent group advised the FDA to ban them last year.

Now in steps the Consumer Healthcare Products Association (CHPA) to save the day (sort of).

(more…)

by James Hubbard, M.D., M.P.H.

An article in the August 2008 journal Pedatrics investigated unexpected infant deaths in Arizona over a span of 1 year (2006) The common factor in 10 out of 21 autopsied babies (all under age 1) was that each had over-the-counter cough and cold medications in their system. Although this could not be confirmed as the cause of death, it is suspicious and just another reminder that children, of a certain age, should not be given these medications, ever. The article states that 123 deaths of children under 6 have been reported to the FDA in all.

Actually the FDA has already issued a warning against giving these meds to children under 2. The FDA’s Drug and Pediatric Advisory Committe says no one under 6. So what should do when your child is under 6 with a bad cough?

(more…)

by James Hubbard, M.D., M.P.H.

If we are not supposed to give cold medicines to kids anymore, then what is a parent to do?

Is honey the answer? With good timing a study came out in the December 2007 Archives of Pediatric and Adolescent Medicine showing that buckwheat honey is more effective than dextromethorphan (dm) in cough in children 2 and over. (more…)

by James Hubbard, M.D., M.P.H.

Have you heard about the FDA’s new cold-medicines advisory: not to give them to kids under 2? If you’d like to read it for yourself–including the FDA’s bullet-pointed tips–rather than go through the media, here’s a link.

Below is a shorter blurb (originally posted here).

[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA’s recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue.