I Can Buy it Over the Counter: FDA Followup

In my last entry, I told you that cough and cold remedies marketed for infants had been removed from the shelves of drug stores across the country. This move was made in response to concerns raised by a group of pediatricians who charged that these medications are dangerous and ineffective. An FDA advisory panel met this past week to review these charges and to make recommendations about ongoing sales of these medications and what, if any, warning labels should be attached.

As reported yesterday in The Washington Post, “The Food and Drug Administration panel voted 13 to 9 to recommend against the use of the products for children in that age group [children under the age of 6] after concluding overwhelmingly that there was insufficient evidence the long-used remedies worked in youngsters.”

The group’s chair, Dr. Mary Tinetti, stated, “The sentiment here is that they should not be used.”

The problem is that these drugs have never been adequately tested in children, so there is no evidence that they work. There is evidence, though, that they are dangerous, and the same Washington Post article quotes a report from the Centers for Disease Control that at least 1500 children under the age of 2 suffered complications from the use of these products between 2004 and 2005. These were not minor complications, either, as these drugs have been linked to convulsions, heart problems, neurologic complications, and at least 123 deaths.

I’m very proud that this action resulted from my colleagues in the Baltimore City Health Department speaking up, raising awareness, and pushing the issue, ultimately resulting in safer medication use for our children.

One final note: This issue has larger implications than just cough and cold medicine. These actions by the FDA are a result of inadequate testing of drugs on children, and on the false assumption that dosing of drugs in kids can be estimated by simply giving proportionally less medicine. But, as I was taught in residency – children are not just small adults. New drugs need to be tested not just on adults, but also on children, with particular attention to proper dosing and a real estimate of how well they work. If the financial hit to the pharmaceutical company from this action by the FDA is sufficient, maybe the net result will be more appropriate testing of new drugs in kids, something we sorely need.