FDA Offers New Guidelines in Tylenol Dosing

By: Victor Sun Pharm D.

Acetaminophen (Tylenol) is one of the most commonly used pain relievers in America today. Copiously used over the counter for minor pains, it is one of the main ingredients found in prescription pain medications such as Percocet, Vicodin and Tylenol with codeine.

Acetaminophen over-dosage is one of the most common and severe forms of overdose. The maximum recommended dose for acetaminophen is 3000mg a day for the average adult. Patients who exceed this dosage, experience overdose symptoms starting with nausea and vomiting, fatigue, abdominal pain and ultimately liver failure if left untreated. Overdoses are common because acetaminophen is so prevalent in combination pain and cold medications. Unaware patients taking one or two extra strength Tylenols as needed, along with a prescription strength pain medication containing acetaminophen, easily reach 3000mg a day.

Since Jan 14, 2014 the US Food and Drug Administration has urged health care providers to stop prescribing medications with more than 325mg of acetaminophen. The FDA has concluded that the benefits of using more than 325 mg of acetaminophen in drugs like Percocet and Vicodin are few. Studies supporting the use of higher strength acetaminophen, such as 500mg and 650mg in prescription products, have only shown to be marginally more effective at pain relief as compared to formulations with strengths of 325mg. The FDA has concluded that the benefits of a higher dose formulation do not outweigh the risks of liver damage from acetaminophen overdose.

Back in 2011 the FDA requested drug manufacturers to reduce the amount of acetaminophen in their products, with half of the manufacturers complying and already producing products with low strength of acetaminophen. Products such as Vicodin now come in strength of 5mg/300mg, 7.5mg/300mg and 10mg/300mg offering similar pain relief with lower risks. Healthcare professionals are strongly encouraged to prescribe these new products to help avoid acetaminophen overdoses in patients.

Patients who are taking prescription strength painkillers such as Percocet or Vicodin should avoid taking more than one acetaminophen product at a time. Patients should also avoid drinking alcohol while taking acetaminophen, as alcohol can exacerbate damage to the liver.

In general, Tylenol and products containing acetaminophen are safe to use. This is why the FDA has allowed higher strength of the drug to stay over the counter. But as a precautionary measure, patients should be aware that taking more acetaminophen than the liver can handle is dangerous and such drugs should be taken with caution.