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No pain, all gain for Tylenol as it turns 50

Sales of the best-known acetaminophen brand have grown by double digits since fall 2004.

Associated Press
Published November 1, 2005

TRENTON, N.J. - Tylenol, originally a pain reliever for children, has hit middle age.

The world's best-known acetaminophen brand turns 50 today, and it's more popular than ever, in part because of its reputation as the safest nonprescription pain reliever. Even a fatal 1982 poisoning scare barely hurt the brand - and led to tamper-proof packaging.

Already in medicine cabinets in 70 percent of U.S. households, Tylenol now is seeing sales jump amid concern over the risks of other painkillers. Sales have grown by double digits since fall 2004, according to maker McNeil Consumer & Specialty Pharmaceuticals of Fort Washington, Pa.

"It's become the fastest-growing pain reliever in 2005," said Ashley McEvoy, general manager of McNeil Consumer, part of New Brunswick, N.J., health care conglomerate Johnson & Johnson.

Tylenol sales are up about 9 percent in 2005's first nine months, after holding or declining slightly the three years before, according to Chicago market research firm Information Resources Inc. Sales last year totaled $786.5-million, but IRI doesn't track sales to hospitals, nursing homes or Wal-Mart stores.

One reason for growing sales is that since September 2004, popular prescription painkillers Vioxx and Bextra were pulled from the market because of increased risk of heart attack and stroke. This year, the Food and Drug Administration warned other anti-inflammatory drugs carry such risks.

Tylenol is in a separate drug class from anti-inflammatories such as Vioxx, ibuprofen and naproxen. Compared with those drugs and aspirin, Tylenol is less likely to interact with other medications, irritate the stomach or cause internal bleeding, and it is safe for patients with common conditions such as heart disease and diabetes.

"Doctors and patients are confident they won't have these kinds of complications," said Dr. Michel Dubois, director of research at the New York University Pain Management Center. "That's why it has been so popular."

Dubois said that despite J&J's aggressive marketing, Tylenol is not the best choice for arthritis pain because it does not reduce inflammation. It also has a rare risk of liver damage at very high doses.

Acetaminophen had been used in Europe since 1893 but was little known in the United States when the Tylenol brand was launched in 1955. McEvoy said Tylenol was the first aspirin-free, nonnarcotic pain reliever on sale in the country - available only by prescription, for children and in liquid form. McNeil, acquired by J&J in 1959, rolled out the first Tylenol for adults in 1961.

Tylenol's biggest challenge, the 1982 cyanide tampering scare in Chicago that killed seven people, is considered "a case study of how to deal with a brand crisis," said Mark Bard, president of Manhattan Research. He said pharmaceutical companies such as Vioxx manufacturer Merck & Co. and Bextra manufacturer Pfizer Inc. "could learn some lessons from what happened 20 years ago."

J&J had its sales force remove 264,000 Tylenol bottles from Chicago area stores. Consumers also were urged to return any Tylenol they had for a safe bottle, and prompt alerts from J&J and the FDA kept the public informed, said Dr. Anthony Temple, head of medical affairs for McNeil Consumer in 1982.

"If you leave people in the dark, you have a real risk of them never being able to trust you" again, said Temple, now senior medical consultant for McNeil Consumer. It took just a few months to regain public confidence, he said.

Bard said it was worth it for J&J to spend about $100-million on the recall to save its brand, given that nonprescription drugs are on the market for decades, compared with prescription drugs that lose patent protection, and thus most of their sales, in 10 to 15 years at most.

The culprit was never caught, but McNeil prevented a recurrence by developing containers protected by multiple seals.

"They made tamper-proof packaging, which we take for granted today" on everything from nonprescription drugs to pickle jars, Bard said.

[Last modified November 1, 2005, 04:58:03]

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