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FDA warns of rare skin reaction caused by acetaminophen
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The FDA today released a warning that acetaminophen can cause rare but serious skin reactions.
Although rare, Stevens-Johnson Syndrome and toxic epidermal necrolysis are the two most serious skin reactions linked to acetaminophen, according to a consumer update posted on the agency web site today.
Problems usually begin with influenza-like symptoms followed by rash, blistering and extensive damage to the surfaces of the skin. Recovery can take weeks or months, and possible complications include scarring, changes in skin pigmentation, blindness and damage to internal organs, according to the FDA.
Acute generalized exanthematous pustulosis can also result from acetaminophen use and typically resolves within 2 weeks of stopping the medication.
“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” Sharon Hertz, MD, deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction, said. “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.”
FDA said it will now require that a warning about these skin reactions be added to the labels of all prescription medicines containing acetaminophen. FDA will work with manufacturers to get the warnings added to the labels of over-the-counter medicines containing acetaminophen.
This causal link was discovered as part of the FDA Adverse Event Reporting System (FAERS). A search of FAERS uncovered 107 cases from 1969 to 2012 that resulted in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products; the cases were categorized as either probable or possible cases associated with acetaminophen, according to the FDA.
Go to the FDA’s Consumer Updates page for more information.
Perspective
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Edward A. Bell, PharmD, BCPS
As acetaminophen is perhaps the most commonly used medication in the pediatric population, this news, although describing a rare event, is important to consider. As the FDA indicates, it is difficult to accurate access how often this adverse effect occurs. Given that acetaminophen is likely given to hundreds, if not thousands of infants, children, adolescents and adults daily, a true incidence is difficult to determine. There is probably no immediate need to significantly change how acetaminophen is used and recommended to our patients for pain and fever, other than to apply an axiom that can be reasonably applied to every medication described in this journal: drugs should be used therapeutically as wisely as possible. Every drug, no matter safe we may view its use, has potential for harm (ie, adverse effects). A true benefit should outweigh a drug’s risk at all times.
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