Tylenol’s Maker Ends Capsule Use : Johnson & Johnson Switches to Pills for Patent Medicines

Johnson & Johnson, in a difficult $150-million marketing decision, announced Monday that it no longer will produce or sell Tylenol capsules--or any other over-the-counter medicine in capsule form--because it cannot guarantee the products’ safety.

“We feel the company can no longer guarantee the safety of capsules to a degree consistent with Johnson & Johnson’s standards of responsibility to its consumers,” James E. Burke, the company’s chairman, told a news conference at the firm’s New Brunswick, N. J., headquarters near here.

Nine days ago, cyanide-laced Tylenol capsules killed a 23-year-old Peekskill, N. Y., woman. A second bottle of Tylenol capsules poisoned with cyanide subsequently was found in a store just two blocks from the supermarket where the first bottle had been purchased.

Won’t Re-Enter Field

“Johnson & Johnson will no longer manufacture or sell any capsule products made directly available to the consumer, and we have no plans to re-enter this business for the foreseeable future,” Burke said.

In Washington, the head of the Food and Drug Administration, Frank E. Young, said: “This action taken by Johnson & Johnson was a matter of its own business judgment and it represents responsible action taken under tough circumstances.”

But Young called it “premature” to discuss whether other pharmaceutical companies should stop the production of over-the-counter medicine in capsule form.

“We think Johnson & Johnson did what they had to do,” said John T. Walden, a spokesman for the Proprietary Assn., which represents 83 companies in the United States that make more than 95% of medicines sold without prescriptions.

Packaging Defended

“The problem is still confined to its (Johnson & Johnson’s) medicine, and we don’t think it follows that the same solution follows for all capsule medicine . . . . Over-the-counter medicines are still the most safely packaged in the world,” Walden said.

Johnson & Johnson will substitute Tylenol in caplet form for all forms of Tylenol in capsule form, which had been the nation’s best selling pain-killer. Unlike capsules, which are usually made of gelatin and can be taken apart easily, caplets are oval-shaped solid pills, especially designed to be easy to swallow.

The company will also replace capsule forms of its Sine-Aid and Dimensyn medicines with caplets. When the process is completed, 15 million packages will have been taken off shelves and out of warehouses.

“We have taken this action with great reluctance and with a heavy heart, but we cannot control random tampering with capsules after they leave our plant,” Burke said. “Therefore, we feel our obligation to consumers is to remove capsules from the market and protect the public.

” . . . While this decision is a financial burden to us, it does not begin to compare to the loss suffered by the family and friends of Diane Elsroth.”

Sales Halted

The company has not manufactured or sold Tylenol capsules since Feb. 10, when Elsroth, a young stenographer, died at the home of her boyfriend in the New York suburb of Yonkers after taking Extra-Strength Tylenol laced with cyanide.

Soon afterward, Johnson & Johnson urged consumers to stop using the capsule form of the product, and states across the nation ordered Tylenol capsules pulled off store shelves.

“We fought our way back from the Chicago tragedy in 1982, thanks to the fairness and good judgment of the American consumer,” Burke said. “We will do it again this time.”

Seven people in the Chicago area were killed in 1982 by cyanide-laced Tylenol. No one has been charged in those poisonings. But, after they occurred, Johnson & Johnson began producing and test-marketing Tylenol in caplet form. The firm found that consumers accepted the oval caplets as comparable to capsules in ease of swallowing.

Soon after Elsroth’s death, Johnson & Johnson began an intensive review of capsule safety technology. It concluded that someone determined to tamper with capsules could do so, despite the steps taken after the 1982 poisonings to ensure the safety of its capsules.

3 Seals on Each Bottle

Those steps included three seals on each bottle of Tylenol capsules, with prominent warnings against using capsules from damaged packages. The box containing the bottle was glued tightly shut. A plastic band sealed the cap to the neck of the bottle. And the bottle’s mouth was sealed with a tough foil membrane.

But those precautions proved insufficient.

“What we tried to do is look at all other technologies to improve the capsule form from a safety point of view,” Burke said Monday. “We came to the conclusion we couldn’t improve it.”

Studies showed that Tylenol in capsules made up 30% of the total Tylenol market. Burke said at a press conference last week that 14 million Americans used Tylenol capsules, while more than 30 million used other forms of the medication.

Market research surveys by Johnson & Johnson after Elsroth’s death showed that the company and the media had been effective in issuing warnings: More people in the New York area knew that they should stop using Tylenol capsules than knew the name of the President of the United States.

In addition, the surveys asked Tylenol capsule users nationwide how likely they would be to buy caplets. Fifty-nine percent said they would be willing to try the substitute form. Before introducing caplets in test markets in 1983, the company had asked consumers their preference for pill shape. The caplet design won easily.

‘Not Going to Defeat Us’

“I don’t think we’re defeated,” said Burke, who was named chairman of Johnson & Johnson in 1976. “The so-called terrorist made no demands on us. We have not given in to any demands . . . . What we’ve really done here is say to whoever made this act: ‘You’re not going to defeat us. We’re coming back again. We’re going to give the consumer a safer product, better product in light of the fact that you have found a way to invade our package, which we thought was the best that could be made.’ ”

John Norris, the FDA’s deputy commissioner, said that his agency would begin to conduct studies in an effort to strengthen the tamper-resistant properties of capsules. He said that capsules have advantages over other forms of drug packaging. Capsules are especially effective in dispensing time-release medications, which allow a drug to enter the blood stream at a steady dose over a sustained period of time. The elderly find capsules particularly easy to swallow, he said.

Others May Follow Suit

Some pharmacists said Monday that Johnson & Johnson’s decision to halt production of over-the-counter capsules could force other companies to do the same.

“It will knock everyone out of the box in capsules for a long time,” said Fred Young, pharmacist at Prescription City South in Chicago. “ . . . I tell everyone to use tablets now.”

John J. Goldman reported from New York and Marlene Cimons from Washington.