“Alarming” Number of Stevens-Johnson Syndrome Cases Linked to Tylenol Active Ingredient: Study

While most people consider Tylenol and other acetaminophen products to be relatively safe, a new study warns that the drug may account for more than one out of every 20 cases of a severe skin reactions, known as Stevens-Johnson syndrome, which can lead to painful burning of the skin, blindness and even death.

In findings published last week in the medical journal Cureus, researchers from Louisiana State University report that more than five percent of all cases of Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are linked to side effects of acetaminophen, which is one of the most widely used pain medications, not just in Tylenol, but also found in a number of over-the-counter pain and cold medications.

Stevens-Johnson syndrome (SJS) side effects produce painful blisters, severe rash and can cause the skin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is typically referred to as toxic epidermal necrolysis (TEN), typically resullting in the need for treatment in a hospital Intensive Care Unit (ICU) or Burn Unit.

Prior studies have linked the development of Stevens-Johnson syndrome to anticonvulsants, antibiotics and non-steroidal anti-inflammatory drugs (NSAIDS), but acetaminophen has always been one of the most widely cited causes.

In 2014, the FDA required new label warnings for Tylenol and other acetaminophen drugs due to the risks of SJS and TEN.

Tylenol SJS Risk

In this new report, researchers conducted a narrative review of studies on SJS, TEN and the use of acetaminophen over the last 15 years.

One recent study the researchers examined indicated that acetaminophen was linked to 5.2% of all SJS/TEN cases, though there appears to be a higher correlation with some people who have specific genetic predispositions, particularly among Asian populations. Other studies the researchers looked at appeared to link Tylenol use with a higher risk of death from TEN, but those findings have been inconclusive overall.

“While other drugs such as allopurinol and carbamazepine have been shown to be large contributors to SJS/TEN, physicians must be aware of the alarming percentage of cases caused by acetaminophen,” the researchers warned. “This correlation is not commonly mentioned in the literature and can lead physicians to not recognize the potential effects or causations of a patient with SJS/TEN. Furthermore, cases of SJS/TEN are usually rare, so more attention needs to be called to healthcare workers to recognize acetaminophen and its adverse effects.”

The researchers estimated about 9.2 million cases of SJS and 1.9 million cases of TEN are reported in the U.S. every year. In cases of Tylenol-linked skin reactions, the onset of symptoms occurred within two to three days. That compares with much longer incubation periods linked to other drugs, such as anticonvulsants, allopurinol and other drugs, where symptoms may manifest in four to 21 days.

“Awareness of these adverse afflictions can lead physicians to make more informed decisions to respond to SJS/TEN cases efficiently,” the researchers concluded. “Acetaminophen is a staple drug for antipyretic and analgesic effects, but physicians must consider the potential risks and outcomes to deliver thorough patient care and to quickly respond in the case of an emergency.”

Tylenol Pregnancy Side Effects

The researchers in this latest study note that acetaminophen’s unique mechanism of action leads it to being viewed favorably by pregnant women as an analgesic and antipyretic drug, which has led to Tylenol’s widespread use worldwide. However, this may increase the over the overall global risks of SJS/TEN, particularly among Asian populations where certain genetic variants linked to the skin reactions are more common.

These findings come as Johnson & Johnson and other drug makers already face a growing number of Tylenol lawsuits over failure to adequately disclose the pregnancy risks associated with acetaminophen. A series of studies have been published in recent years which indicate that in utero exposure may increase the risk that a child is later diagnosed with autism or ADHD.

Lawsuits allege that information about the link between acetaminophen and autism has been withheld from families and medical providers for decades, causing children to develop the life-long disability.

Given common questions of fact and law over the adequacy of the Tylenol pregnancy warnings, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings late last year, centralizing all lawsuits brought throughout the federal court system before U.S. District Judge Denise Cote in the Southern District of New York, as part of a federal multidistrict litigation (MDL).

As part of the coordinated pretrial proceedings, it is also expected that the court will establish a “bellwether” process where a small group of representative cases will be selected for early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation. However, if the parties fail to negotiate Tylenol autism settlements or another resolution for the litigation in the MDL, each family’s lawsuit may eventually be remanded back to different U.S. District Courts nationwide for future trial dates.