FDA advises against using extra-strength acetaminophen

April 29, 2014

Apparently, the FDA's warning four months ago was missed by many physicians, pharmacists and patients, so the drug agency, in an unusual move, saw fit Monday to remind us: Stop writing prescriptions for, stop dispensing prescriptions for, and stop taking medications containing more than 325 milligrams of acetaminophen.

Your liver will thank you, since acetaminophen overdose has overtaken viral hepatitis infection as the most common cause of . It is now the second most common cause of requiring transplantation in the United States.

"These products are no longer considered safe by FDA and have been voluntarily withdrawn" by the manufacturers, the FDA said.

Just four months ago, the FDA called for doctors, dentists and pharmacists to stop recommending the higher dose, which, the FDA said, has demonstrated no superiority over the lower dose but poses dangers to the . The FDA does not usually have to repeat itself. But acetaminophen has become a workhorse of our home medicine chests, and an ingredient contained in many combination medications, including the opiate pain-relievers Percocet and Vicodin and in such over-the-counter stalwarts as Benadryl, Excedrin, Nyquil, Robitussin, Theraflu and Vicks.

"We encourage pharmacists to return them to the wholesaler or manufacturer," the FDA said, and to remove the product codes for prescription medications containing such doses from their automatic reordering systems. When patients come to fill prescriptions for products containing more than 325 mg of acetaminophen, the FDA recommends that pharmacists call the prescriber to discuss a lower dose.

As explained by Harvard Medical School's Family Health Guide, most is broken down into harmless substances that are removed from the body in urine. "But a small percentage is rendered into a compound that's extremely harmful to cells," the guide says.

The compound is known by the acronym NAPQI, and it's combined with an antioxidant called glutathione to make it safe to ingest. But in the case of an overdose, there's "not enough glutathione to sop up NAPQI," making a threat.

Explore further: US urges acetaminophen limits due to liver risks

Related Stories

US urges acetaminophen limits due to liver risks

January 15, 2014
US regulators said Wednesday they are urging doctors to cease prescribing drugs that contain more than 325 milligrams of acetaminophen per tablet due to concerns over liver damage.

Doubling up on cold, flu remedies may harm liver

January 30, 2013
(HealthDay)—Taking too much acetaminophen, an active ingredient in many commonly used drugs for fever and pain relief, including Tylenol, can cause liver damage, experts at the U.S. Food and Drug Administration warn.

FDA warns of rare skin reactions to acetaminophen

August 2, 2013
(HealthDay)—The widely used painkiller acetaminophen, best known as Tylenol, can cause rare but serious skin reactions and a warning about this danger will be added to product labels, the U.S. Food and Drug Administration ...

Common cold meds may pose health threats

March 19, 2014
(HealthDay)—Over-the-counter sinus and pain remedies that combine two common ingredients—phenylephrine and acetaminophen—might cause serious side effects such as high blood pressure, dizziness and tremors, New Zealand ...

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

1 comment

Adjust slider to filter visible comments by rank

Display comments: newest first

autismepi
not rated yet Apr 29, 2014
The list of risks for acetaminophen is long and growing. The most serious concerns are two new studies which show adverse neurodevelopment in children whose mothers used acetaminophen while they were pregnant. The study in 3 year olds (Brandlistuen et al. 2013) found a 70% increased risk of motor and behavioral problems and double the risk of communication problems (autism phenotypes). The study in 7 year olds (Liew et al. 2014)
found increased risk of ADHD behaviors and Hyperkinetic Disorders.

This is in addition to close to 30 studies finding an association to asthma and allergic disorders, 4 studies finding an association to male congenital malformations(cryptorchidism) and additional studies finding associations to skin disorders and mind numbing (relief of existential dread).

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.