Tylenol Latest Big Brand to Come Under FDA Scrutiny

Panel Seeks to Limit Acetaminophen in OTC Medication; Drug Is Used in Many Marketers' Products

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NEW YORK (AdAge.com) -- First, the Food and Drug Administration went after Cheerios. Now it appears to be targeting another beloved U.S. brand: Tylenol.

The FDA advisory panel recommendation could present advertising problems for J&J and Tylenol, as well as the rest of the big players in the pain-relief industry.
The FDA advisory panel recommendation could present advertising problems for J&J and Tylenol, as well as the rest of the big players in the pain-relief industry.
An FDA advisory panel has recommended that the regulatory agency reduce the maximum dosage of acetaminophen, the main ingredient in over-the-counter pain relievers such as Johnson & Johnson's Tylenol and Novartis' Excedrin, to 325 milligrams a pill from 500 milligrams a pill, and to fewer than 4,000 total milligrams a day. It's also recommending that the single 1,000-mg dose be available only by prescription. The same panel earlier had recommended pulling two prescription medications that contain acetaminophen, Percocet and Vicodin, off the market.

Ad challenges
The FDA, which says acetaminophen remains the leading cause of liver failure in the U.S., does not have to follow the recommendations of its advisory panels -- but it almost always does.

That could present advertising problems for J&J and Tylenol, as well as the rest of the big players in the pain-relief industry. All told, marketers spent $423 million on OTC pain-relief medications in 2008, according to TNS Media Intelligence, including children's medications. J&J was by far the leader in the category, with measured media spending of $105 million in 2008 on its various Tylenol products alone.

According to Norwalk, Conn.-based IMS Health, Tylenol led the $2.6 billion acetaminophen category with more than 30% market share.

No plans yet
Marc Boston, a spokesman for McNeil Consumer Healthcare -- the J&J affiliate that markets Tylenol -- said the company will not have any comment on its marketing plans, and that its statement suffices for now. That statement, in part, reads: J&J "strongly disagrees with the committee's recommendation. ... As the FDA stated in its own assessment, the risk with acetaminophen is at doses in excess of the recommended amount (overdose). We believe the FDA needs to take this key consideration into account as they deliberate on these advisory-committee recommendations and before they make any final decisions. ... The safety and efficacy of acetaminophen has been established in over 150 clinical studies and is supported by over 50 years of clinical use. Acetaminophen is the pain medicine that doctors recommend most."

Based on McNeil's history of responding to such crises, however, it's a safe bet the marketer and its lead creative agency on Tylenol, Interpublic Group of Cos.' Deutsch, New York, are already plotting a communications offensive to reassure consumers. When a slew of pain-relievers containing acetaminophen were recalled a few years ago after fragments of metal were found in them, McNeil and Deutsch turned around print ads touting the product's safety in a matter of 24 hours.

The company has already done some advertising damage control, changing its website for Tylenol. In a link titled "Your Safety Is Our Number One Priority" on Tylenol.com, a message from Edwin K. Kuffner, M.D., the senior director of medical affairs for McNeil Consumer Healthcare, stresses the safety of the product.

McNeil defends safety of product
"Recently, there have been reports about acetaminophen, the medicine in Tylenol, and the potential for liver damage if the medicine is misused or taken in overdose amounts," Mr. Kuffner wrote. "The U.S Food and Drug Administration (FDA) held a public meeting June 29th & June 30th to discuss this very issue. ... Tylenol, when taken as directed, remains the safest pain reliever people can take. It's important for people to know that it's not the recommended dosage of acetaminophen that poses the risk. Rather, it's when people take more than the recommended dose either intentionally, often because they think it will work better -- which is not the case -- or unintentionally, often because they don't realize that several products they are taking at the same time (both prescription and OTC) each contain acetaminophen. ... The safety and efficacy of acetaminophen has been established through more than 50 years of clinical use and scientific investigation and it is safe when used as directed."

Clark Rector, exec VP-government affairs for the American Advertising Federation, said it was too early for his group to comment.

Advantage Advil?
Linda A. Suydam, president of the Washington-based Consumer Healthcare Products Association, issued a statement saying, "While we are pleased with the committee's recommendation to allow continued access to OTC combination medicines containing acetaminophen because we know they provide real benefits to consumers, we are disappointed in their divided vote to lower the maximum daily dose and the single dose of 1,000-mg acetaminophen. There was a notable lack of data referenced by the committee to support these recommendations and overwhelmingly strong data affirming the efficacy and safety of acetaminophen in its current dosage forms."

In its statement, J&J alluded to a possible side effect -- a business side effect, that is -- when it wrote that "McNeil Consumer Healthcare believes that this recommendation is likely to lead to more serious adverse events as consumers shift to other over-the-counter products such as nonsteroidal anti-inflammatory drugs in search of pain relief. Compared to other over-the-counter pain medicines, acetaminophen has unique safety advantages for patients and consumers with certain medical histories and conditions."

Read: If the FDA does indeed curb the dosage of acetaminophen and limits the use of Tylenol and Excedrin, the company could lose sales to aspirins and ibuprofen products such as Wyeth's Advil.

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