A prominent pharmacist has raised alarms about the potential dangers associated with a widely used medication, warning that it might lead to significant health issues, including organ failure and dementia. Dr. Ethan Melillo, from Rhode Island, specifically expressed his disdain for Tylenol PM, one of America’s leading nighttime pain relievers that generates nearly $1 billion in annual sales.
Dr. Melillo describes the 17-cent pills, popular for alleviating headaches and minor aches, as being ‘misused’ by many individuals. He cautions that regular use can result in liver damage due to its acetaminophen content. Additionally, diphenhydramine, an ingredient designed to promote sleepiness, poses a risk of memory loss.
When acetaminophen is metabolized in the liver, it produces a small quantity of a toxic byproduct known as NAPQI. Typically, the body’s natural antioxidant glutathione neutralizes this substance. However, consuming high doses of acetaminophen—or having reduced glutathione levels due to factors such as alcohol consumption or malnutrition—can overwhelm the liver’s ability to process NAPQI. This accumulation can cause cellular injury and may ultimately lead to liver failure.
Dr. Melillo highlights that the risk of liver damage escalates significantly when individuals consume more than 4,000 mg of acetaminophen daily, which equals over eight Tylenol PM tablets. He points out that acetaminophen is also prevalent in numerous other medications, urging consumers to check for this ingredient and its dosage in various products.
He is not completely opposed to the use of acetaminophen but stresses it should not be a habitual choice. He attributes the high prevalence of liver damage in the U.S. partly to widespread acetaminophen consumption, with liver disease affecting approximately one in three Americans, totaling around 100 million individuals.
The FDA responded to these concerns in January 2011, mandating that manufacturers of combination medications containing acetaminophen limit the dosage to no more than 325 mg per tablet or capsule, as there is no evidence that exceeding 325 mg provides additional benefits while increasing the risk of liver injury.
Despite these recommendations, each Tylenol PM tablet contains 500 mg of acetaminophen and 25 mg of diphenhydramine. Research has also indicated that acetaminophen may alter risk perception, making activities seem less dangerous. A study conducted by The Ohio State University found that participants who took 1,000 mg of acetaminophen rated high-risk activities such as bungee jumping and skydiving as less hazardous compared to those who took a placebo.
Furthermore, Dr. Melillo expresses concerns about diphenhydramine, the main ingredient in Tylenol PM, which blocks histamine and promotes drowsiness. He notes that most people recognize it by its brand name, Benadryl. He is particularly worried about its potential to induce memory loss as it acts as an anticholinergic medication, blocking acetylcholine, an important neurotransmitter for cognitive function.
One study found that daily use of an anticholinergic drug for three years or longer increased the risk of dementia by 54% compared to those who took the same dosage for only three months.
The side effects of diphenhydramine include dry mouth and urinary retention, which can pose significant issues for older adults, potentially exacerbating other age-related health problems. Dr. Melillo advises those struggling with sleep to consult a physician about prescription alternatives instead of relying on Tylenol PM or Benadryl, which could lead to dependency.
He concludes,
If you’re someone who takes this on a blue moon, then that’s fine, it’s not a big deal. But this should not be your go-to medication for sleep every night… because you’re gonna want to prevent long-term complications.
