FDA Safety Review Recommends Banning Cough Medicines for Kids Under Six

Washington, DC: In what is poised to become yet another test of the US Food and Drug Administration (FDA), the release of an exhaustive safety report on children’s cough medicines recommends a total ban for children under 6 years of age.

Given there are more than 800 products on the market directed at children, this could turn into a closely-watched debate as the FDA – partially funded by the pharmaceutical industry – attempts to play Solomon and weigh the need for protecting children and reflecting modern data against outdated notions, versus making allowances for established business and commerce.

In the Old Days…

It used to be, decades ago, that children were regarded as tiny versions of adults. Cough suppressants were therefore formulated to work within their tiny bodies.

Given that children can get up to ten colds a year, and the realities of modern life with two parents working, it’s little wonder that the children’s cough medicine industry has surged to include some 800 products, 200 of which are not approved by the FDA but medicines to which parents and caregivers have access, anyway.

Reality Check…

From 1969 to 2006, at least 54 children are reported to have died after taking decongestants, and 69 did not survive after taking antihistamines, according to the safety review. What’s even more tragic is that given adverse reaction reports are submitted voluntarily, we may never know the actual number of children who have died after taking these medications, the report concluded.

The safety review, conducted under the jurisdiction of the FDA, was initiated after data released by the Centres for Disease Control and Prevention in Atlanta (CDCP) which revealed that more than 1500 children under the age of 2 years had suffered serious health problems after being treated with common cold and cough medicines. The data covered a period between 2004 and 2005.

How effectively the FDA responds to the report by its own safety reviewers, remains to be seen. But there were a couple of related events that also happened on September 28, when the report was released.

On Friday the FDA warned all manufacturers of some 200 unapproved prescription cold and cough suppressants containing the narcotic hydrocodone that they have until the end of October to stop making the above-noted products for children under the age of 6. Makers of all other unapproved hydrocodone products have until the end of the year to stop manufacturing them.

There are seven approved products containing hydrocodone, for which doctors can still write prescriptions with the blessing of the FDA.

Also on Friday, the Consumer Healthcare Products Association recommended in its own, independent 156-page study the implementation of mandatory warning labels which state these medicines should not be used in children under the age of two years.

The Association does not back an outright ban.

Current sales figures and usage are not known, but in 1994 researchers reported in The Journal of the American Medical Association that more than a third of all three-year-olds in the United States were administered over-the-counter cough and cold medications in one 30-day span.

What’s more, in 1990 Americans spent more than $2 billion on cold medicines for their children. One can imagine what current sales figures might suggest.

It sets up, at best, a robust debate between the FDA and the manufacturers of these 800 products. At worst, it could escalate into a war as the makers of over-the-counter cold remedies for our kids dig in to defend a lucrative product line.

The FDA safety review, spanning 356 pages, is exhaustive in scope. What remains to be seen is the length the FDA will go, in the end, to do what’s best for our children.

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