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Reflecting its reputation for crisis management and rapid response, Johnson & Johnson (J&J) moved quickly when the Food and Drug Administration (FDA) recommended potentially stringent new limits on acetaminophen (the main ingredient in Tylenol) dosages. In an effort to reassure Tylenol users, J&J placed full-page ads in most major newspapers that promised acetaminophen was safe when consumers followed dosage instructions and thus that Tylenol is “the safest brand of pain reliever you can choose.”

If the FDA’s recommendations to lower the maximum daily dose of acetaminophen becomes mandate, J&J will have to turn Extra-Strength Tylenol into a prescription-only drug. This is because each Extra-Strength pill would exceed the maximum daily dose of acetaminophen. In the meantime, the company must constantly remind customers that taking more than the current recommended dosage can cause serious liver damage

In its consumer protection role, the FDA already has warned consumers to stop using certain Zicam Cold Remedy nasal products that caused some users to lose their sense of smell. It also requires that drugs such as Darvon and Darvocet, which combine acetaminophen with other specific ingredients, post warnings on their labels about the risks of a fatal overdose.

Yet the safest dose for acetaminophen remains under debate. Tylenol advertisements claim vigorously that current dosage recommendations are safe, but J&J may be forced to recant its claims if the FDA makes a final decision to lower the dosage levels.

Johnson & Johnson is considered a leader for its responsible reputation and crisis management skills. In 1982, Extra Strength Tylenol was it deliberately tampered with and contaminated, killing seven people. J&J immediately withdrew all Tylenol from retail store shelves even before they knew the cause of the deaths.  J&J has a lot to defend!

Discussion Questions:

  1. Why is J&J printing ads to respond to the FDA’s recommendation, even before the agency has come to a final decision?
  2. Would you rethink your usage of Tylenol after hearing the FDA’s recommendation to limit to maximum dose?

Vanessa O’Connell and Shirley Wang, “J&J Acts Fast on Tylenol,” The Wall Street Journal, July 9, 2009.