What are the new regulations for acetaminophen mandated by the Food and Drug Administration (FDA)?
Acetaminophen (Tylenol) is a widely used over-the counter (OTC) and prescription medication for fever reduction and pain relief.1 The drug is generally considered safe with minimal adverse effects when administered appropriately (i.e. daily dosage not to exceed 4 grams). Daily doses greater than 4 grams may result in liver toxicity. During the late 1990s, acetaminophen overdose became the most common cause of acute liver failure (ALF) in the United States (US), surpassing hepatitis B infection, and the incidence of acetaminophen-induced hepatotoxicity continues to increase.1,2 Since 1998, the Food and Drug Administration (FDA) has been trying to reduce acetaminophen-induced hepatotoxicity through a variety of means including adding an alcohol warning to OTC acetaminophen labeling, creating educational programs, and obtaining assistance from state boards of pharmacy.2 Recently, the FDA issued stricter regulations regarding acetaminophen labeling in an effort to reduce the ever increasin
