Tylenol warnings are coming soon the pain reliever near you.
The Tylenol warnings about overdoses will be seen on the pill bottle’s caps.
The Tylenol warnings are a result of lawsuits and pressure from federal authorities against the maker of Tyleno, Johnson & Johnson.
Tylenol warnings will start to appear in October.
The Tylenol warnings will be in red to let users know that taking too much of the popular pain reliever carries the potentially fatal risks.
Tylenol warnings are an unusual step for over-the-counter drugs.
The Tylenol warnings alert millions of users may signal widespread ramifications for over the counter pharmaceutical.
Johnson & Johnson says, starting in October in the United States, the Tylenol warnings will be seen on the cap of new bottles of Extra Strength Tylenol.
In the coming months, Tylenol warnings will follow on most other Tylenol bottles.
The Tylenol warnings will make it explicitly clear that Tylenol contains acetaminophen, which is a major cause of sudden liver failure.
Edwin Kuffner, vice president of McNeil Consumer Healthcare, said, “We’re always looking for ways to better communicate information to patients and consumers.” McNeil Consumer Healthcare is the Johnson & Johnson unit that makes Tylenol.
The Centers for Disease Control and Prevention and the Food and Drug Administration says that every year 55,000 to 80,000 people in the U.S.
go to the emergency room because of acetaminophen overdoses.
The Tylenol warnings will alert people that at least 500 people are killed from acetaminophen overdoses every year.
Acetaminophen is an ingredient in over 600 over-the-counter and prescription drugs that are used by almost one in four American adults every week.
Acetaminophen is found in Nyquil, Excedrin and Sudafed.
Tylenol will be the first of these products to have a warning label.
The Tylenol warnings will read: “CONTAINS ACETAMINOPHEN” and “ALWAYS READ THE LABEL.” Johnson and Johnson has over 85 personal injury suits in federal court pending.
The lawsuits blame Tylenol for liver injuries and deaths.
The Food and Drug Administration will also write safety proposals for Tylenol and other acetaminophen product use.
According to retail data service Information Resources Inc.
Johnson & Johnson’s Tylenol brought in over $1.75 billion last year.
Experts worry most about “extra-strength” Tylenol, which contains 1,000 milligrams of acetaminophen.
Regular strength Tylenol only has 650 milligrams of acetaminophen.
Extra Strength Tylenol is so popular that some drug stores don’t even stock regular strength.
If used as directed, acetaminophen is safe.
That means people should only take 4,000 milligrams or less a day.
The is about eight pills of Extra Strength Tylenol.
100 million Americans use acetaminophen every year.
Only one percent of users experience liver damage but liver specialists say those cases are preventable.
Experts say part of the problem is that there a hundreds of pills in a bottle.
It is easier for users to take too many.
Extra Strength Tylenol bottles have up to 325 tablets Dr.
William Lee of the UT Southwestern Medical Center studied acetaminophen toxicity for forty years.
He says, “The argument goes that if you take acetaminophen correctly you will virtually never get into trouble.
But it’s the very fact that it’s easily accessible over-the-counter in bottles of 300 pills or more that puts people in harm’s way.” Lee thinks the new Tylenol warnings are a step in the right direction.
Tylenol is marketed as “the safest kind of pain reliever” when used as directed.
Lee says “That has been their standard ploy in the past, and I would argue that safest it is not.” Kuffner says “When taken as directed, when people read and follow the label, I believe that Tylenol and the acetaminophen ingredient is one of the safest pain relievers on the market.” Consumer Healthcare Products Association says McNeil is the only major drug maker that will right now adopt the Tylenol warning at this time.
Consumer Healthcare Products Association Vice President Emily Skor says, “While this is not an industry wide initiative at this time, it fits squarely within the many ongoing industry-wide educational initiatives to further acetaminophen safe and responsible use by consumers.” McNeil has updated the Tylenol warnings on Tylenol since the 1990s, when J&J added a warning about the risk of liver damage if you took Tylenol while drinking alcohol after former President George H.W.
Bush aid Antonio Benedi fell into a coma and had to have emergency liver transplant after mixing Tylenol with wine at dinner.
A jury awarded Benedi $8.8 million in damages after they found that McNeil didn’t warn consumers about the risk.
In 1998, The Food and Drug Administration made the alcohol warning mandatory for all acetaminophen makers.