Past Tylenol Label Updates and Dosage Changes

The latest change to the Tylenol packaging is that the cap of the product will now read “Contains Acetaminophen” and “Always Read the Label.”  Click here to read more about this latest change.

However, this is not the first time Tylenol has added new warnings to its label.  In 1994, Johnson & Johnson subsidiary McNeil added a warning regarding the risk of liver damage when consumers take Tylenol and drink alcohol.  The change was spurred by a lawsuit brought by an aide to the first President Bush.  Antonio Benedi was taking Tylenol while he was having wine with his dinner.  He ended up with liver complications so severe that he had to have an emergency liver transplant.

Benedi brought suit against McNeil in federal court, and was granted $7.855 million in compensatory damages, plus another $1 million in punitive damages.  Records showed that McNeil had knowledge of 16 deaths that had occurred as a result of Tylenol being taken with alcohol, but had still failed to properly warn of the risk.

After this lawsuit, McNeil voluntarily added a warning regarding the dangers of mixing acetaminophen and alcohol.

Another change came in 2002 when an FDA panel advised that all products containing acetaminophen  should carry a warning regarding the risk of serious liver damage.  In 2004, such a warning was voluntarily added to Tylenol products by McNeil.  It was made mandatory by the FDA in 2009.

Another change was made in 2009, this time to the dosage of Tylenol.  Another FDA panel recommended lowering the dose from 4000 milligrams (8 tablets of extra-strength Tylenol) to 3000 milligrams (6 tablets of extra-strength Tylenol).  McNeil adopted this change as well.

Now however, the FDA is proposing a change that McNeil has refused.  In an attempt to reduce the number of cases of liver damage, the FDA wants McNeil to eliminate the extra-strength dosage altogether.  The panel wants the extra-strength dosage to be available by prescription only.  McNeil has rejected this proposition, arguing that consumers will turn to anti-inflammatory drugs such as Advil if they do not have the option of the more effective dosage of Tylenol, and that anti-inflammatory drugs have even greater risks than acetaminophen.

Currently, the FDA is in the process of revamping its rules on acetaminophen for both adults and children.  The changes are expected to be complete by the end of 2013.


Have you suffered liver damage as a result of Tylenol?

If you have taken Tylenol or any other acetaminophen product and suffered liver injury or liver failure, the attorneys at Kirkendall Dwyer LLP can help.  Contact our attorneys today for a free case review.