FDA Warns of Rare but Serious Skin Reactions with Acetaminophen
The U.S. Food and Drug Administration (FDA) is informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, can be fatal. Acetaminophen is a common active ingredient to treat pain and reduce fever and is included in many prescription and over-the-counter products.
Serious Side Effects
Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Other drugs used to treat fever and pain/body aches (eg, nonsteroidal anti-inflammatory drugs [NSAIDS] such as ibuprofen and naproxen) also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels.
Anyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away. Anyone who has experienced a serious skin reaction with acetaminophen should not take the drug again and should contact their health-care professional to discuss alternative pain relievers/fever reducers.
Health-care professionals should be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an association, when assessing patients with potentially drug-induced skin reactions.
New Labeling Requirement
This new information resulted from the Agency’s review of the FDA Adverse Event Reporting System database and the medical literature to evaluate cases of serious skin reactions associated with acetaminophen. It is difficult to determine how frequently serious skin reactions occur with acetaminophen, due to the widespread use of the drug, differences in usage among individuals (eg, occasional vs long-term use), and the long period of time that the drug has been on the market; however, it is likely that these events occur rarely.
FDA will require that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions. FDA will also request that manufacturers add a warning about serious skin reactions to the product labels of over-the-counter acetaminophen drug products marketed under a new drug application and will encourage manufacturers of drug products marketed under the over-the-counter monograph do the same.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
