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The Honolulu Advertiser
Posted on: Tuesday, December 26, 2006

Clearer drug labeling can help save lives

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Considering the way our pill-popping society turns to painkillers, a new call by the Food and Drug Administration for clearer labels — on box and bottle — sounds like a good prescription.

Users need to know, beyond the brand name, exactly what they're taking and the inherent precautions regarding dosing and drug combinations.

The painkillers in question are internal analgesics such as acetaminophen, commonly sold as Tylenol. They also include aspirin, ibuprofen (Nurofen, Dorival, Motrin, Advil, Act-3), naproxen (Anaprox, Naprelan, Aleve) and ketoprofen (Orudis, Oruvail).

The FDA said that these over-the-counter painkillers are safe when used properly. The new concern comes from the growing number of deaths from stomach bleeding and liver failure due to misuse. A 1997 study in the Annals of Internal Medicine put casualties from painkillers at an estimated 7,600 deaths and 76,000 hospitalizations.

It's important to note, however, that those numbers are still small compared with the total number of painkiller users overall. A 2005 Sloane Survey on U.S. Medication estimated that acetaminophen is the most commonly used drug in America, with 60 million Americans taking it each week.

It's that high usage that makes the call for improved labeling a sensible step.

The proposed regulations would require safety information displayed with specific warnings. For example, acetaminophen would have a prominent warning of the potential for liver damage.

According to the FDA, a number of drug manufacturers voluntarily have implemented labeling changes. That's good for consumers and businesses.