Tylenol warnings on the caps of Extra Strength Tylenol come as a response to liver failure and death lawsuits. The new Tylenol warnings on the caps of Extra Strength Tylenol bottles reemphasizes to consumers that Tylenol contains acetaminophen. “The message will reinforce existing warnings that the over-the-counter pill contains the ingredient acetaminophen, which has been linked to fatal liver failure,” reported BusinessWeek on Aug. 29, 2013.
The new bright and bold red Tylenol warning on the caps of Tylenol bottles is trying to warn consumers of the risks of taking too much acetaminophen. Even though the Tylenol warning is already included in fine print on the packaging of Tylenol bottles, acetaminophen has been found to be the leading cause of liver failure in the United States.
The lawsuits against Johnson & Johnson allege that liver failure and death occurred also in people who followed the warnings on the Tylenol bottles, according to Associated Press video report.
Besides liver failure, acetaminophen can also cause fatal skin reactions. According to The Merck Manual, one to three weeks after beginning to take an offending drug like acetaminophen, a person might develop malaise, fever, headache, cough, and conjunctivitis. The FDA will require prescription and non-prescription drug manufacturers to add warning labels about the potential skin reaction to acetaminophen.
“The FDA discovered the risk of skin diseases while reviewing adverse events reported in its database between 1969 and 2012, during which 107 cases of significant skin reactions were reported, 67 people were hospitalized and 12 people died.”
One of the major problems that is being highlighted in the lawsuits is that acetaminophen is included in over 600 different products.
“Acetaminophen is the most common drug ingredient in America and can be found in more than 600 different over-the-counter and prescription medicines which include Tylenol, Midol, Benadryl, Nyquil, Sudafed, Robitussin, Vicks, and other products. Many of the products containing acetaminophen are used as pain relievers, fever reducers, sleep aids as well as cough, cold, and allergy medicines,” reported the Examiner on Aug. 3, 2013.
Against the lawsuits, Johnson & Johnson argues that even though a person might be taking the correct dosage of Tylenol as indicated on the warning bottle, a consumer might in fact be taking an overdose of acetaminophen when adding other prescription or non-prescription medication like sleep aids or cold medicines.
Prescription labels on other products do not always show the name acetaminophen but sometimes list shorter versions such as “APAP,” or “acetam.”
Extra Strength Tylenol tablets contain 500 milligrams of acetaminophen. According to the BusinessWeek report, “the FDA cut the amount of acetaminophen that prescription products could contain to 325 milligrams per pill two years ago.” However, the reduced amount of acetaminophen is not being reinforced by the FDA.
Johnson & Johnson is the world’s largest maker of health-care products and the company’s over-the-counter drugs accounted for about 6.5 percent of the company’s $67 billion in sales last year.
In an e-mail today, Johnson & Johnson announced that the new Tylenol warning will begin in October. The new Tylenol warning on the caps will say “CONTAINS ACETAMINOPHEN” and “ALWAYS READ THE LABEL.”