Infant pain reliever dosing 'fix' shows label limitations

A new dosage concentration of liquid acetaminophen intended to protect infants from potentially fatal overdoses may actually be compounding the problem. To improve dosing accuracy, some (but not all) manufacturers adopted for their infant products the lower concentration dosage already in use in liquid acetaminophen products for older kids. Just the dosage—the amount of liquid given—would differ between infant and child treatments.

As a result of the partial adoption, however, the lower dosage concentration (160 milligrams per 5 milliliters) now available for infants sits on retailer shelves alongside the older, higher concentration (80 mg/0.8 mL and 80 mg/mL) products previously used for infant products only. Users now have to check dosage concentration as well as dosage.

It's likely to stay that way, too, because the manufacturers that didn't make the switch to the lower concentration will continue to populate retailer shelves with the higher concentration acetaminophen, maintaining the mismatch of products that look very much alike.

To help minimize the confusion, the FDA executed a multiform communication blitz in December 2011 that included a drug safety announcement, consumer update, Q&A page, separate information sheets for patients and healthcare professionals, and even a podcast. The message is consistent in all of these communications: Read the label carefully before administering the drug.

If all this effort is required to get consumers to read OTC drug labels, then labeling as a means of communication with them has failed. The same can be said—although to a lesser degree—about the densely packed, tiny-type missives included with prescription drugs; even the endless lists of side effects and advisories that accompany prescription drug ads. Do we really think anyone is paying attention?

The FDA communication blitz proves that drug labels on OTC products are ineffective, and hanging in the balance is the safety of infants vulnerable to liquid acetaminophen overdoses.

It's time to fix the labels. - George Miller

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