NCHR Testimony at the FDA Advisory Committee Meeting on Codeine in Children’s Prescription Cough Medication

My name is Dr Diana Zuckerman and I am president of the National Center for Health Research.  Thank you for the opportunity to speak today at this important meeting regarding codeine in children’s prescription cough medication.

Rather than focus on discrepancies in research results, I urge you to focus on important meta analyses.    As you can see on my first slide, last year’s Cochrane review found no solid scientific data to support efficacy in children of any age with chronic cough.  The European Medical Agency also found a lack of evidence compared to placebo, but medicines with codeine were no more effective than non-opioid cough medicines – but with worse side effects.

Older Cochrane reviews also failed to support the use of cough medicine with codeine for children for either chronic or acute cough.

As has been stated, cough medicine with codeine is given to children to help them sleep.  If you think that’s a reasonable use, then FDA approval should be for codeine as a sleeping pill for children, not a cough medicine.

As you know, one in 12 children and adults have a gene that makes them more vulnerable to codeine, and it is especially dangerous for them – and can even be fatal.  That is another reason to avoid exposing children to codeine, knowing that there are no established benefits for coughs.

The risks of codeine are very well established and can be fatal.  With no clear evidence of benefit, how can FDA possibly conclude that the benefits outweigh the risks for children of any age?

My final slide is an important reminder that warnings about which children are especially at risk are not sufficient.

Research indicates that the risks are greater for children who are obese, for example, but research clearly shows that most parents of obese children don’t realize that their children are obese.  As this slide shows, approximately one-third of all children in the U.S. today are overweight or obese, but parents of only 4% of all children realize that their children are overweight or obese.  In contrast, 29% of children are obese or overweight but their parents think they are a healthy weight.

Although doctors would presumably be making the decision of whether or not to prescribe cough medicine with codeine, we don’t know whether those doctors will be aware that the children are obese and not merely overweight.  Doctors would have access to that information, but the child may not be labeled as obese in their medical chart.  Certainly, the data clearly show that most doctors of obese patients are not telling the parents that their children are obese.

In conclusion, there are serious risks and no clear benefits for cough medicine with codeine for children of any age.  And while we can’t say for certain whether giving opioids to children has long-term negative effects contributing to opioid abuse by teenagers, that logically makes sense.  Why not prevent opioid use in children when we can?