Industry Updates: Acetaminophen Safety Information

Acetaminophen is the generic name of the drug Tylenol. It is an analgesic used widely and effectively in both prescription and OTC products to reduce pain and fever. When taken in recommended doses, acetaminophen is typically very effective with little to no side effects. However, when taken in excess its effects can cause severe liver injury that can lead to liver failure, liver transplant, or even death.

Many patients do not take acetaminophen in excess intentionally. There are so many prescription and OTC combination drug products containing acetaminophen that patients don’t always realize that they are taking multiple doses of acetaminophen, therefore taking more than the recommended dose. The FDA reports that from 1998 to 2003, acetaminophen was the leading cause of acute liver failure in the United States with 48% of those cases being accidental overdoses. In another study, data shows that from 1990 to 1998 there were an estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths related to acetaminophen-associated overdoses.

In January of this year, the FDA asked manufacturers of prescription acetaminophen combination products to limit the maximum amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit. The FDA believes that these limitations will make these products safer for patients and will reduce the risk of severe liver injury.

In addition to setting the 325 mg maximum per dose, the FDA is also requiring manufacturers to include a Boxed Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching or rash) on the label of all prescription drug products that contain acetaminophen.  The new labeling also requires manufacturers to include a warning of the potential risk for severe liver injury.

Drug companies will have three years from the date of publication of the Federal Register Notice (January 14, 2011) to limit the amount of acetaminophen in their prescription drug products to 325 mg per dosage unit. Over-the-counter products containing acetaminophen will not be affected by these changes since they are already labeled with the liver damage warning.

As a pharmacy technician, it is important that you are aware of the many acetaminophen combination drug products, both prescription and OTC. Review the table below for current prescription acetaminophen combination drug products and notice which ones will need to be reformulated. Being an informed and aware pharmacy technician is invaluable to a pharmacy team and to the pharmacy patrons.

Common Acetaminophen-Containing Prescription Products

Brand Name Generic Name Strength
Tylenol w/ Codeine #3 acetaminophen; codeine phosphate 300 mg; 30 mg
Fioricet acetaminophen; butalbital; caffeine 325 mg; 50 mg; 40 mg
Lortab 5 acetaminophen; hydrocodone bitartrate 500 mg; 5 mg
Lortab 10 acetaminophen; hydrocodone bitartrate 500 mg; 10 mg
Norco 5 acetaminophen; hydrocodone bitartrate 325 mg; 5 mg
Norco 10 acetaminophen; hydrocodone bitartrate 325 mg; 10 mg
Vicodin acetaminophen; hydrocodone bitartrate 500 mg; 5 mg
Vicodin ES acetaminophen; hydrocodone bitartrate 750 mg; 7.5 mg
Vicodin Hp acetaminophen; hydrocodone bitartrate 660 mg; 10 mg
Percocet acetaminophen; oxycodone hydrochloride 325 mg; 2.5 mg, 5 mg, 7.5 mg, & 10 mg
Ultracet acetaminophen; tramadol hydrochloride 325 mg; 37.5 mg

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