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A History of Tylenol

Tylenol: the early years

Tylenol was developed by McNeil Laboratories. It has as its active ingredient a generic compound that can be manufactured by most pharmaceutical companies: acetaminophen. After Johnson & Johnson acquired McNeil in 1959, it began aggressively to advertise the product—to health professionals—as an analgesic that was as effective as aspirin but easier on the stomach. By 1970, sales of Tylenol were growing about 20 to 30 percent annually, with projected sales to reach about $60 million by 1975.

With the release of a number of studies in the early 1970s which questioned the wisdom of widespread dependency on aspirin as a pain-killer, the use of acetaminophen accelerated with Tylenol accounting for 90 percent of acetaminophen sales. Two-thirds of Tylenol users were introduced to the product by physicians. Others became familiar with it through hospitals, where it was used extensively—not necessarily because it was the medication of choice, but because it was generally less expensive than other analgesics and less interactive than aspirin.

When a 1976 survey showed that consumers were generally aware that Tylenol was easier on their digestive system than other analgesics but felt that this benefit was achieved at a loss of efficacy to reduce pain, Johnson & Johnson introduced Extra-Strength Tylenol. Extra-Strength Tylenol became the first nonprescription analgesic to contain 500 mg of pain-killer per unit—the established industry dosage was 325 mg for regular and 400 mg for extra strength. The product was advertised as the most potent OTC pain-reliever, and sales climbed.

Tylenol: the 1982 poisonings

In fall 1982, four people, all living in Chicago suburbs died of cyanide poisoning. Each had recently ingested one or more Extra-Strength Tylenol capsules. When a fifth person died, having in her possession six capsules—four of which tested positive for outside contamination with cyanide—Johnson & Johnson realized that it was facing a very serious public health problem. The company recalled all 31 million Tylenol capsules still on the store shelves nationwide. After spending about $62 million in promotions, Tylenol recaptured 85 percent of its prior market share by 1983. Once again, Tylenol was the best-selling analgesic, holding 30 percent of the $1.3 billion nonprescription pain-killer market.

Tylenol: the landmark lawsuit

The level of consciousness concerning the safety of Tylenol rose because of a 1994 lawsuit in Virginia. In Antonio Benedi v. McNeil, a former White House aide to President George Bush, Antonio Benedi, sued McNeil Consumer Products, alleging negligent failure to warn of the possible dangers of mixing Tylenol with alcohol and for breach of implied warranties. The plaintiff, who claimed he was in good health when he began taking Extra-Strength Tylenol in the recommended dose to treat the flu, alleged that this liver loss resulted from taking the analgesic with wine at dinner. The jury found for Benedi and awarded him $7.8 million in compensatory damages and $1 million in punitive damages.

Following the Benedi decision, other suits were filed against McNeil Consumer Products alleging negligence for its failure to warn about interaction between alcohol and recommended doses of acetaminophen.

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