A new draft guidance document issued by the U.S. Food and Drug Administration (FDA) calls for all over-the-counter drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions.

The FDA’s new guidance, “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions,” follows a 2013 warning by the agency that acetaminophen is associated with a risk of developing serious skin reactions.

Those reactions, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), are known to be fatal and can occur after just a single use.

While the FDA said it was difficult to determine the exact frequency with which the acetaminophen side effects occurred, regulators said that they believed the events occurred “rarely.”

FDA Warning About Acetaminophen SJS Risks

The FDA’s new draft recommendations are intended to warn consumers and healthcare providers about the risks of all single and combination ingredient acetaminophen over-the-counter (OTC) products. Under the new guidance, the FDA “does not intend to object to the marketing of products containing the following warning language:

“Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.”

According to the FDA, the language should be included in the “warnings” section of the acetaminophen product labeling. While the guidance is technically non-binding, the FDA could object to the marketing of any product not containing the warning, preventing it from being sold.

Acetaminophen and Stevens Johnson Syndrome

Stevens Johnson Syndrome (SJS) is a painful and sometimes fatal severe allergic skin reaction, most often caused by medications. While technically any medication may cause SJS, there are different types which are more prone to causing SJS than others.

One group is OTC medicine containing acetaminophen, one of the most common ingredients in painkillers, such as Tylenol.

Stevens Johnson Syndrome symptoms can begin with a fever, sore throat and headache and over a few days can turn into skin lesions and blisters and respiratory infection. Often an SJS rash is not diagnosed in time, and the condition becomes life-threatening.

Symptoms of SJS and TEN, skin reactions to acetaminophen, include initially hives, a rash, facial swelling, and an inability to eat and drink. As it progresses, SJS symptoms include blisters or sores in the mouth, eyes, throat, or genitalia, open lesions or raw sores, a progressively worsening body rash, blistering and detachment of skin, and any unexplained or persistent fever.

SJS Lawsuits

Many over-the-counter drugs such as acetaminophen — found in Tylenol — have been linked to Stevens Johnson Syndrome. The warning labels of Tylenol and other acetaminophen products will be updated to include the risk of SJS and TEN, but until now the public had not been warned about these potentially life threatening conditions.

Many victims of SJS have filed SJS lawsuits against drug makers for failing to warn about the risk of developing Stevens Johnson Syndrome from medications such as acetaminophen. SJS lawsuits charge drug makers with negligent marketing and labeling practices, and seek compensation for hospital bills, pain and suffering, and more.