Last month, the FDA added all acetaminophen-containing products to its “watch list.” Indeed, Medical Examiners like me have known for several decades now that acetaminophen (Tylenol) is a leading cause of fatal liver failure. In fact, today it’s the No. 1 cause of fatal liver failure in the U.S.
The EPA imposes billions of dollars in costs each year to keep hepatotoxic (toxic to the liver) chemicals out of the environment. OSHA imposes billions of dollars each year on businesses to limit hepato-toxins in the work place. But the FDA approves for sale, to millions of innocent consumers seeking only pain relief, the No. 1 liver toxin in the country!
Yet amazingly enough, acetaminophen has never been subjected to the same level of scrutiny regarding its safety as other painkillers. The FDA even recommends this common over-the-counter drug as a substitute for “dangerous,” effective opioid painkillers
But, thankfully, the FDA finally added acetaminophen to their Adverse Event Reporting System (FAERS).
It’s not for liver failure!
So, what is all the new concern about? After millions and millions of doses administered over many decades?
It turns out the FDA placed all products containing acetaminophen on the “watch list” because of…
Severe skin reactions.
Fatal liver failure does cause some spectacular skin reactions, such as yellow jaundice. But this is not the reason for the new FDA action.
No–the FDA put acetaminophen on its “watch list” because of concerns that it causes hives, rashes, and itching.
Well, it appears the FDA’s long-delayed concerns about acetaminophen are truly only skin deep!
Indeed, you’ll remember that making it onto the FDA “watch list” does not mean that the drug poses the specific health risk reported to FAERS. Or that physicians should stop prescribing it. Or that patients should stop taking it. So making the FAERS list is really pronounced “FARCE.”
However, it does mean that the FDA will investigate whether there is a causal risk. The agency will investigate whether acetaminophen actually causes all this itching. If yes, FDA would “consider” a regulatory action. Such as gathering more data. Revising the drug’s label. Or even requiring a risk evaluation or mitigation strategy.
So at best, we might expect a new FDA warning about rashes and itching. But don’t expect any new warnings about liver failure.
If this latest FDA action is not surreal enough, there is more stranger-than-fiction news about Tylenol this week.
Researchers from the University of British Columbia recently studied Tylenol’s so-called “psychological” effects. In a recent study, UBC doctoral students recruited more than 120 college students and randomly divided them into two groups. The first group took 1,000 mg of Tylenol. The second group, or the control group, took a placebo (or sugar pill).
Then the real silliness began…
In the first experiment, researchers ask the students in the Tylenol group to write about what would happen to their bodies after they died. And how they would feel about it. (If they could still feel anything at all.)
Then, they asked the control group to write about experiencing dental pain. This would be unpleasant, but unlikely to invoke “existential dread.”
Next, all the participants read a fictional arrest report about a prostitute. The researchers asked the students to set her bail on a scale of zero to $900.
Now, dear reader, please stay with me, because this is what constitutes important “psychological research” at major universities these days.
The researchers expected the students who took Tylenol to set higher bonds for the prostitute after considering the reality of their own death. They expected these students to feel the need to assert their values. (If you can’t follow this reasoning, good–don’t worry–you don’t need a psychologist!)
But the researchers were wrong.
The students who took Tylenol, while thinking about their own deaths, set lower bail amounts.
But researchers did not observe this effect among students asked to think about dental pain. And who didn’t take Tylenol.
These observations suggested to researchers that Tylenol “may numb worries about death.”
But the researchers were not done yet.
In a second test, the researchers showed half the students a short clip from the TV show “The Simpsons.” And they showed the other students a clip from “Rabbits,” a series of short films by the director David Lynch. These short films have the same eerie, dread-inducing effects as Lynch’s better-known works like “Twin Peaks” and “Mulholland Drive.”
Next, all the students viewed footage from the 2011 Vancouver hockey riots. Apparently, the students who took Tylenol seemed to feel more lenient toward the rioters.
So, what does this research really prove?
That taking Tylenol and watching cartoons, sports riots, and David Lynch films (often indistinguishable from each other) is how college students now pay to pass their time (after their parents pay their tuitions). And how college researchers are paid to pass their time
The researchers stated that their study suggests that Tylenol may be good for easing psychological pain and anxiety. And maybe that’s not such a bad thing…take two Tylenol and stop worrying about dying from liver failure.
Call it another backward victory for psychological drug research.
These findings ran in the April 11 issue of the journal Psychological Science. This publication seems determined to prove that its two-word name is an oxymoron by publishing this kind of research.
“The common pain of surrealism and death: Acetaminophen reduces compensatory affirmation,” Psychological Science. Advance online publication April 11, 2013