Acetaminophen, the over-the-counter and prescription drug for fever and pain relief an pain for adults and children alike received new warning guidelines this month from the U.S. Food and Drug Administration. Acetaminophen may cause three rare and potentially lethal allergic skin reactions; Stevens-Johnson Syndrome, toxic epidermal necrolysis, known as TEN, and acute generalized exanthematous pustulosis, or AGEP.
Looking at its Adverse Event Reporting System data, the FDA found 107 cases of adverse skin reactions from 1969 to 2012, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products and the cases were categorized as either probable or possible cases associated with acetaminophen.
“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.”
Matthew Pitlick, PharmD, an assistant professor of pharmacy practice from the St. Louis College of Pharmacy, said persons taking acetaminophen need to know the signs and symptoms of these very severe skin conditions.
“What does happen when these reactions pop up is that the skin becomes very, very red; very inflamed; blisters form and there can be severe peeling of the skin as well,” Pitlick described.
The FDA reports the reactions can occur at any time.
“It can happen in the first doses or it can happen after subsequent doses after you’ve been taking it, “Pitlick added.
“If you’ve been taking the drug for years, it’s likely that nothing is going to happen now. For the most part, when these skin conditions do pop up – it can happen with other drugs as well, not just acetaminophen – it usually happens within the first few doses.”
Acetaminophen is the main ingredient in the popular Tylenol brand and generic equivalents.
Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions. FDA is requiring an added warning about these skin reactions on the labels of all prescription medicines containing acetaminophen.
Moreover, it considers the benefits of acetaminophen to outweigh the risks.
“FDA’s actions should be viewed within the context of the millions who, over generations, have benefited from acetaminophen,” Hertz said. “Nonetheless, given the severity of the risk, it is important for patients and health care providers to be aware of it.”
Pitlick concluded, “As far as me and my practice and what I’m going to do, I’m still going to recommend acetaminophen to my patients and my family for the majority of times when they have mild pain.”
