Tylenol has been found to increase the risk of three serious skin reactions. The Food and Drug Administration (FDA) has alerted health professionals and consumers that while the reactions are rare, their risk should be noted.
The three rare but severe skin reactions are Stevens-Johnson Syndrome (SJS), toxic epidermal necrosis (TEN) and acute generalized exanthematous pustulosis (AGEP).
SJS and TEN are the more serious of the three and could possibly be fatal. AGEP usually resolves within two weeks of stopping the medication, stated EMRP.com.
“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications," said Sharon Hertz, M.D., deputy director of FDA's Division of Anesthesia, Analgesia and Addiction.
"However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare, but serious, side effects, which are potentially fatal."
Stevens-Johnson Syndrome (SJS) often starts with flu-like symptoms. A painful red or purplish rash with blisters follows. It is treated as a medical emergency usually requiring hospitalization.
Mayoclinic.com stated that the cause of the condition is thought to be due to a reaction to medication, infection or illness.
Toxic epidermal necrosis (TEN) is most typically caused by a medication. Some feel that SJS and TEN are related but TEN has more extensive skin involvement.
TEN can have spots or no spots but can have widespread redness that causes areas to become eroded, followed by detachment of the skin. Mucous membranes are most often involved first, stated Emedicine.com.
Acute generalized exanthematous pustulosis (AGEP) generally starts as a fever the same day as the rash appears and within 24 hours after taking the medication, reported Medscape.com.
It appears as a multiple small pustular rash that predominantly affects main body folds and the upper trunk, though the face can be affected. AGEP resolves after discontinuing the suspected drug, which helps identify the cause.
According to the FDA Adverse Event Reporting System (FAERS) there were 107 cases, 67 hospitalizations and 12 deaths from 1969-2012 due to acetaminophen complications. The FDA is requiring warnings about these potential rare skin reactions to be added to labels of prescription drugs that contain acetaminophen.
Tylenol, frequently labeled as acetaminophen, is used in many cold, cough and allergy medications. The FDA has future plans for the warnings to be added to all OTC medications that contain acetaminophen.
FDA: Acetaminophen May Cause Rare But Serious Skin Reaction. Monthly Prescribing Reference. Retrieved August 3, 2013.
FDA Warns of Rare Acetaminophen Risk. FDR.gov. Retrieved August 3, 2013.
Stevens-Johnson syndrome. Mayoclinic.com. Retrieved August 3, 2013.
Toxic Epidermal Necrolysis. Emedicine.medcape.com Retrieved August 3, 2013.
Drug Eruptions in Dermatology. Medscape.com. Retrieved August 3, 2013.
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Jody Smith