According to the U.S. Food and Drug Administration, 325 is the magic number—325 milligrams of acetaminophen per tablet or capsule, that is. Due to continuous reports of severe liver damage, the FDA requests that manufacturers of prescription combination products containing acetaminophen—such as Vicodin and Percocet –not exceed 325 mg of acetaminophen per dosage unit. Since the initial January 2011 request to place a 325 mg limit on dosage unit by January 14, 2014, a little over half of manufacturers have cooperated on their own volition. The FDA’s actions do not affect over-the-counter acetaminophen products such as Tylenol.
The FDA stated that acetaminophen has been implicated in severe liver injury in patients who “took more than the prescribed dose of an acetaminophen-containing product in a twenty-four-hour period; took more than one acetaminophen-containing product at the same time; or drank alcohol while taking acetaminophen products.” In fact, accidental overdose of these combination products accounts for nearly half of acetaminophen-related liver failure, resulting in transplant or death.
Acetaminophen, when used as directed, safely and effectively alleviates pain and fever. Most people associate the drug with Tylenol; however, most consumers are often oblivious of acetaminophen’s presence in other products—both prescription and over-the-counter. The recipe for typical prescription pain medications (for moderate to severe pain) consists of acetaminophen combined with other ingredients, most often opioids such as codeine, oxycodone and hydrocodone, to form Tylenol with Codeine, Percocet and Vicodin, respectively. “There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury,” said the FDA in statement on January 14th of this year. With a new limit of acetaminophen per capsule, the FDA suggests that physicians can prescribe patients one or two units up to six times a day and still be under the 4000 mg daily limit.
“There is no immediate danger to patients who take these combination pain medications, and they should continue to take them as directed by their health care provider,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. Kweder stated that “The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.” By lowering the maximum dosage per unit, the likelihood for overdose is diminished in the event that someone ingests too many acetaminophen-containing products. The FDA now requires manufactures to print a “Boxed Warning”—the FDA’s strongest type of warning—to stress the risk for potential severe liver damage.
The FDA requests that physicians advise patients not to take more than the prescribed dose of an acetaminophen-containing medication. They also urge doctors to advise patients 1)not to take more than one product that contains acetaminophen 2) to read all prescription and labels to ensure they are not taking multiple acetaminophen-containing products accidentally (such as Tylenol, NyQuil, Vicks and Coricidin) 3)not to drink alcohol while taking acetaminophen-containing medications.
Hopefully, thanks to a greater effort to raise awareness of acetaminophen overdose, there will be significantly fewer cases of severe liver damage. Although the risk of overconsumption may be lower at YU, it is nonetheless imperative to read the label before taking any prescription or nonprescription drugs. The ingredients might surprise you.