The US Food and Drug Administration informed the public about possible skin reactions related to the intake of acetaminophen. In light of this new warning, the FDA will now require drug manufacturers to include written warnings in the labels of drugs containing acetaminophen to remind the public about possible side effects.
Acetaminophen is a common ingredient in popular drugs like Tylenol and the prescription drug Vicodin. It is also found in many other over-the-counter drugs for fever and pain relief.
According to studies, acetaminophen can cause skin reactions that may result in hospitalization and even lead to death. Although the occurrence may be rare, the effect is quite serious and is certainly a reason for caution.
The side effects include toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome (SJS), and acute generalized exanthematous pustulosis (AGEP). These can cause patients' skin to have rashes and blisters. In some cases, the epidermis, or the upper layer of the skin, comes off.
FDA Division of Anesthesia, Analgesia and Addiction deputy director Dr. Sharon Hertz assures everyone that the warnings are not meant to scare people or to lead them into taking other drugs. However, she emphasized that the public should be aware of the symptoms of the effects of acetaminophen so they can respond promptly.
The FDA based its decision to give out a warning from a study that identifies 91 patients who suffered from TEN and SJS and 16 patients who had AGEP because of acetaminophen intake. Of these, 67 were hospitalized and 12 died. The FDA advises the public that should they recognize any symptom that may possibly a result of taking acetaminophen, they should immediately call 911 or go to the hospital for treatment.
Ibuprofen, which is a common ingredient in pain relievers like Advil, and naproxen, which is found in Midol, have carried similar warnings for years.
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