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Poynter Online - Monday Edition: Pain Reliever Warning - Mini Motorcycle


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The other night my wife and I saw a woman, who I now know is Brenda Bass (V.P. of Sales for Tylenol), delivering the following commercial message right in the middle of Olympics coverage. I don't know that I have seen anything quite like it, and I have been surprised that I have seen no mention of it in the news. Shortly, I will tell you why it is news.

The script was provided to me by McNeil Consumer & Specialty Pharmaceuticals, the makers of Tylenol:

AUDIO

Woman VO: Some people think if you have a really bad headache, you should take extra medicine. Problem is, that's not going to get rid of your heaache faster.

And taking too much of any medication, no matter how safe it is, can cause serious problems.

Your health is important to us, so if you're not going to take the recommended dose of our medicine, I'd rather you just didn't take it.

And if that means selling less Tylenol, that's fine with me.

VIDEO

VFX: Images of female with voice to camera

Super: Use only as directed at the recommended dose.

Image of female's handsSuper: Brenda Bass, Vice President of Sales, Tylenol

VFX: Tagline Treatment

STOP.

THINK.

tylenol.com

Tylenol's parent company, McNeil Consumer & Specialty Pharmaceuticals, also ran an ad in USA Today on August 19. The three-column bright red vertical ad includes this message, "We take health seriously, and we want you to take our medicine the same way. Please be sure to read the label and take only the recommended dose. Because while Tylenol is safe when used as directed, it's also strong. And taking too much of any medication can cause serious problems."

As I watched the direct and almost abrasive TV ad I wondered what the heck this was all about. Why would a drug company fire off such a warning about dosing unless there was a crisis at hand? I figured there must be something pretty important behind such an ad. It turns out, there is. And, my friends, there is a story in it for you.

Now, keep in mind, the study I am about to cite has to do with the misuse of various kinds of pain relievers, not Tylenol specifically. But a study I list below, and others cited by the Food and Drug Administration, say clearly that half of all Americans overuse and misuse over-the-counter pain relievers. Three-fourths of us never talk to a doctor or nurse before taking these medications.

Just as the ad says, the results can be pretty serious, even deadly.

I ran across this June 2004 study. The study published by the American College of Emergency Physicians says:

Approximately one in two Americans misuse common pain relievers such as ibuprofen, naproxen, and aspirin, according to results of a new survey released today by the American College of Emergency Physicians (ACEP) and the Emergency Nurses Association (ENA). The survey also found that more than three-quarters of respondents reported never speaking to a doctor or nurse about any potential risks associated with these medications, many of which can be purchased without a prescription, or "over the counter" (OTC).

Most OTC pain relievers fall into the category of drugs called non-steroidal anti-inflammatory drugs, or NSAIDs, which are generally safe and effective for managing pain but can cause serious side effects such as stomach bleeding when misused. NSAID-related complications have been linked with 103,000 hospitalizations and more than 16,000 deaths per year in the United States.

"The results found in this survey are disturbing given that a staggering 30 million people take NSAIDs every day," said Dr. J. Brian Hancock, president of ACEP and an emergency physician. "It's important for consumers to realize that misuse of these medicines can lead to serious side effects which might require emergency care."

The survey, codeveloped by ACEP and ENA, analyzed the behavior of 3,443 people in the United States in regard to their use and misuse of pain relievers. The term "misuse" refers to taking more than the recommended number of pills per dose and/or taking pills more often than the label directs.

The survey showed that most respondents admitted to taking more pills per dose than is recommended, and that nearly half have taken pills more often than is recommended. "People who disregard label instructions to manage chronic pain may be putting themselves at risk of side effects," said Dr. Hancock. "Instead of misusing OTCs, they should be talking to their doctors about how to manage their pain safely."

Indeed, the survey found that 66 percent of people did not read the label...

Kathy Fallon, director of Communications for McNeil, and the spokesperson for Tylenol, reminds me that Tylenol is not an NSAID.

WebMD explains the difference:

Acetaminophen is the active ingredient in Tylenol. NSAIDs include aspirin and drugs containing ibuprofen or naproxen sodium, such as Advil and Aleve.

WebMD continued:

The FDA says many OTC medications sold for different ailments contain the same active ingredient, which can increase the risk of overdose.

For example, cough and cold medications may have the same active ingredient, such as acetaminophen, as a headache medication. Acetaminophen is safe and effective when taken as directed, but taking too much can lead to irreversible liver damage or even death. That risk is higher if the drugs are taking by someone who consumes three or more alcohol beverages per day.

Fallon says journalists can call her at (215) 273-7818 if they have questions about the advertisement or about the campaign. "This campaign is in response to all we have learned from consumers, health care professionals, and the FDA," Fallon tells me. She says it is not in response to any incident involving her company's product.

The FDA launched a campaign armed with a pitiful $20,000 to talk about overdosing. See the FDA press release from January. The release says that the FDA is still considering tougher labeling for over the counter pain relievers. The release said:

In September 2002, FDA's Non-Prescription Drugs Advisory Committee recommended changes to labeling of certain OTC drug products, including acetaminophen and NSAIDS. They advised that these changes are needed to better inform consumers about the ingredients in these products and possible side effects caused by improper use. In addition to this new consumer outreach effort, FDA will consider changing the labeling of these products to further bolster their safe use. FDA is reviewing various changes to labeling for these ingredients that better reflect the latest scientific knowledge about OTC oral pain relievers.

Tylenol has an interesting quiz on the company website (click "Find out the facts about responsible dosing" to take the quiz). I got the first answer wrong.

Pocket Bikes

Picture a mini-motorcycle just 18 inches high. Now picture one traveling alongside buses and cars on city streets. That's what's happening with pocket bikes.

ABC News reports, "Pocket bikes look like a shrunken version of a real motorcycle. But they're so tiny even riders in their early teens hunch over them. Some are powered by electricity, some by gas, with a 49cc engine, just one cc below the size that requires a motorcycle license."

They were first developed in Europe and Japan, but are becoming popular in the United States. ABC News says:

They are now a common sight on city streets. The pocket bike craze has swept from West Coast to East since just last summer. And they are a growing headache for police everywhere in between.

Cement Shortage (follow-up)

What does the national cement shortage mean to commuters? KUT (Austin) radio's Larry Schooler reports construction projects may slow or stop.

Drug Lollipops in Iraq Combat

Has anybody seen one of these out in the field?

Reuters said:

A lollipop containing the pain-relieving drug fentanyl is helpful for controlling pain experienced by trauma patients who don't have immediate access to a hospital, such as those who sustain combat injuries, new research shows.

The lollipop, which is marketed by Cephalon, Inc., under the trade name Actiq, is currently used for cancer pain that's ongoing in nature. However, the new findings suggest that it may also be useful for pain that arises suddenly, according to the report in the Annals of Emergency Medicine.

The findings are based on a study of 22 soldiers who sustained injuries and were given the drug while serving in Iraq last year. All of the subjects had bone injuries or limb wounds that were not life-threatening.

A significant improvement in pain occurred within 15 minutes of getting Actiq, lead author Dr. Russ S. Kotwal, from the University of Texas in Galveston, and colleagues report. Moreover, the level of pain control remained stable for the next five hours without the need for another dose.

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