Originally Published PMPN
January 2004
EDITORIAL
Consumers May Miss the Fine Print
I was surprised in late January when FDA announced its campaign to educate consumers on the safe use of OTC pain relievers. I do, of course, support the agency’s efforts in patient education. I am glad that FDA finally shares so much information with the audience it serves. But I had thought that drug makers had made similar strides. Given their compliance with OTC Drug Facts labeling rules, I didn’t think a nationwide campaign focusing on OTC pain and fever reducers was needed.
I was even more surprised that FDA is also considering changes to the labeling rules for these products. According to its January 22 announcement, the agency wrote, “FDA is reviewing various changes to labeling for these ingredients that better reflect the latest scientific knowledge about OTC oral pain relievers.”
“Pain relievers and fever reducers are safe drugs when used as directed, but they can cause serious problems when used by people with certain conditions or those who are taking specific medicines,” explains FDA commissioner Mark B. McClellan, MD, PhD. “We want to remind consumers who take these products that it’s important to follow current dosing and label directions carefully.”
More labeling changes? What could possibly be wrong? After years of delaying the Drug Facts rules, would industry even accept more changes? I decided to check out the labeling of these products just to see what information could be lacking. I took along my 3-year-old daughter, who was enough of a distraction to mimic any confusion that feverish or pain-stricken shoppers may experience on a similar search.
On such products as Advil Flu & Body Ache, Children’s Tylenol Plus, and Aleve Cold and Sinus, the pain-relievers Ibuprofen, acetaminophen, and naproxen sodium, respectively, were all called out on carton fronts. They were also listed in the Drug Facts Active Ingredients section of each product. The Tylenol product warned consumers not to use it with any other products containing acetaminophen. And the Advil and Aleve products advised patients to ask a doctor or pharmacist before using them with other products containing the same ingredients.
How much more could drug makers warn consumers? I couldn’t think of an answer, until I found another Tylenol product: Multi-Symptom Tylenol Cold. On one panel was the warning, “Do not use with other medicines containing acetaminophen.” It was set within a bright red box. The print was also positioned so that it would be visible again to consumers as they opened the carton.
Could this be what FDA wants? As soon as I saw it, I realized how clear and powerful the warning was. It was much more so than those on the other products I had studied. And I was much more likely to see it. I realized that feverish consumers—or distracted parents—may not always have the clarity to read the fine print.
Daphne Allen
Editor
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