Recalls – A New Kind of “Tylenol Scare”

On September 29, 1982, a “Tylenol scare” began when the first of seven individuals died in Chicago after ingesting Extra Strength Tylenol that had been deliberately contaminated with cyanide. The incident shocked the American public because of its former belief in the safety of the nation’s drug supply. But Johnson & Johnson, manufacturer of the drug, quickly moved to protect its image as a trusted family-owned company; within six days it issued a nationwide recall of 31 million bottles of Tylenol from retailers.

Eighteen years later, in 2010, the OTC drug manufacturing picture has changed somewhat – and not for the better. By October of this year Johnson & Johnson announced its ninth recall of some of its products, including the popular pain reliever, Tylenol. One could argue that this year’s Tylenol scare is even more frightening than the 1982 incident because there is no madman to blame, but only the drug maker itself. The recalls are related to shoddy manufacturing practices and this time the company took 20 months to respond to customer complaints about a musty smell coming from the medicine. The odor is caused by a chemical called 2,4,6-tribromoanisole (TBA), a fungicide used to treat wooden pallets which then leached into the Tylenol stored on them. The nausea, stomach pain, vomiting and diarrhea reported after taking the tainted medicine seems rather benign at first until one reads the FDA statement that, “The health effects of this compound have not been well studied… ”

A Google search of the 2010 Tylenol recalls show top-of-the-page headings declaring that, “The Safety of Tylenol Has Been Established For Over 50 Years” with a link to Tylenol.com, indicating that the company has taken steps to attempt to protect its reputation. In 1982 it was thought that the cyanide poisonings would be the death of the company. Instead, their quick response was seen as socially responsible and doubts about Johnson & Johnson subsided. 2010 is a different story. In October Reuters reported disappointing quarterly revenue for Johnson & Johnson as sales plunged 25 percent. The number of recalls and the company’s slow responses to complaints signal some real problems within the company and public confidence is waning.

Still, the important news about Tylenol and the soaring numbers of other drug recalls in the US is not about profit/loss statements, it’s about drug safety. The corner drug store has always been seen as a place where we can find safe and reliable everyday remedies for common illnesses. If that is no longer true then we have to question the ability of the pharmaceutical industry and the FDA to keep us safe. The recalls have resulted in heightened scrutiny of certain drugs with hearings before Congressional committees. Tighter regulations requiring higher safety standards will help, but responsibility for safety begins with the consumer. Education about the drugs we take, including OTC drugs, is readily available on the internet and from the neighborhood pharmacist. That’s fortunate, because learning to question the medications we put in our shopping basket has become a necessary habit to create.       

 

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