Tylenol, the Most Dangerous Over-the-Counter Drug? Part II
Previously on You Be the Judge:
37 year-old Antonio Benedi felt a case of the flu coming on. After taking the recommended dosage of Tylenol for three consecutive days, he ended up in a coma, near death, and was in desperate need of a liver transplant.
1 culprit ... and each year...
450 Deaths
26,000 Hospitalizations
56,000 Emergency Room Visits
100,000 Calls to Poison Control Centers
The suspect? A very common, everyday drug.
You Be the Judge
Tylenol, the Most Deadly OTC Drug? Part II/II
When people hear about the dangers of Tylenol (or acetaminophen), they often assume that Tylenol only harms people who abuse the medication or who don't follow the directions. Is this true? And is the recommended dosage safe?
It is widely asserted that a daily intake of 7,000 milligrams can severely damage an adult's liver, but the level at which such damage begins to occur is predicted to be much lower. Levels as small as 2,000-4,000 milligrams have been implicated in approximately 10% of deaths related to acetaminophen, proving that the medication does not have to be abused to cause harm.
Considering that a single capsule of extra strength versions of acetaminophen is 500 milligrams, as few as four capsules might damage the liver. This is particularly concerning when you realize that bottles containing 500mg capsules of acetaminophen say that the maximum daily dosage is eight pills, (8 X 500mg) a total of 4,000 mg.
To add to the confusion around this medication, prescription drugs containing acetaminophen often have warnings about liver failure and even death, but the over-the-counter versions do not.
In 2009 the FDA recommended that the adult daily dosage for acetaminophen be reduced from the current maximum of 4,000 milligrams to no more than 3,250 milligrams. McNeil Consumer Healthcare, a Johnson & Johnson subsidiary and the manufacturer of Tylenol, responded that they feared the recommendations could have the effect of steering consumers away from their drugs. To this day the company has not reduced the recommended dosage.
Should Tylenol and Acetaminophen continue to be sold over-the-counter?
Consider the following facts:
1. Hundreds of the drug's users die annually and tens of thousands are hospitalized.
2. Over-the-counter forms do not warn of liver failure or death, while prescription forms often do.
3. Acetaminophen is the number one cause of acute liver failure.
4. The maximum dosage and the manufacturer's recommended safe dosage leave no room for human error.
5. Warnings on the label about alcohol are not very clear.
6. There are no warnings on the label about taking the medication while fasting.
(See the previous episode for details about taking acetaminophen with alcohol or while fasting.)
7. Alternative medications are available that yield the same benefits and far fewer risks.
8. Many experts believe if Tylenol were introduced as a new drug today, it would not be approved.
9. Antonio Benedi took only the recommended dosage and after three days was hospitalized and near death.
The damaging effects of acetaminophen are linked to over 100,000 poison control center calls, 56,000 emergency room visits, 26,000 hospitalizations, and more than 450 deaths each year.
One final thought:
If the side effects and risks linked with acetaminophen were associated with a dietary supplement, it would be pulled from the market immediately.
Do you believe that Tylenol and acetaminophen should continue to be sold over the counter?