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Tylenol - A Bizarre Contradiction

This one has apparently been flying under the radar for awhile.

Recently, we posted a story of how some individuals have been using Tylenol as a method of suicide. The irony here is that according to a study that was done at the University of British Columbia this past spring, the active ingredient in Tylenol – acetaminophen may help people in dealing with “existential dread,” or the overwhelming fear of one's mortality and feelings of uncertainty.

It is one more way in which this drug is being abused, resulting in often fatal liver damage. According to the Center for Disease Control, approximately 78,000 patients are admitted to emergency rooms every year for acetaminophen overdose – and 500 of these cases are fatal. Half of these cases involve intentional overdose.

Amazingly, the effects of acetaminophen on the liver has been known since 1977. At that time, the Food & Drug Administration “recommended” that warnings be placed on the label – but with billions of dollars in profits to be made from Americans whom they have convinced through endless (and expensive) ad campaigns that pills will cure anything that ails them, Big Pharma has been reluctant to do so.   It took nearly over twenty years for the FDA to require any warning at all – a box warning advising patients to avoid alcohol when taking acetaminophen (and that only after a former aide to President Bush  wound up having to get a liver transplant after drinking wine on top of taking Tylenol one night – and his subsequent lawsuit in which McNeil wound up paying him $8.8 million). It took another decade before the FDA made warnings about liver damage mandatory (to McNeil's credit, the company started putting its own warnings on the bottle voluntarily five years earlier).

Finally, come October, Johnson & Johnson's McNeil division, which manufactures and markets the drug, will start placing red warnings on caps of Extra Strength Tylenol. Of course, company representatives say “the warning is a result of research into the misuse of Tylenol by consumers.” One suspects, however, that impending lawsuits and the prospect of additional regulations that could curb availability and sales have more to do with it. Though McNeil has voluntarily lowered the recommended dosage, the FDA is considering rules that require a doctor's prescription for doses in excess of 650 milligrams (the current recommended dosage is 1,000 milligrams).

Naturally, McNeil argues that a lower dose “less effective and could drive people to take anti-inflammatory pain relievers” such as aspirin and ibuprofen. The company points out that these drugs can cause ulcers and gastrointestinal bleeding.

It would be nice to believe that McNeil and other large pharmaceutical companies truly have consumers' best interests at heart. There remains little evidence to that effect.

Sources

Buditz, D.S., et. al. “Emergency Visits for Overdoses of Acetaminophen-Containing Products. American Journal of Preventive Medicine,  vol. 40 no. 6 (June 2011).

Gannon, Megan. “Tylenol May Ease Anxiety Over Death.” LiveScience, 16 April 2013.

Hughes, Carol. “Suicidal Teen Turns to Tylenol.” Albany Times-Union, 7 August 2013

Perrone, Matthey. “J&J Launches New Cap to Curb Tylenol Overdoses.” Associated Press via Abiline Reporter News, 29 August 2013.

Learn more about Tylenol lawsuits

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