FDA Initiative Focuses on Safe Use of Acetaminophen

Acetaminophen is one of the most commonly used medicines in the United States. When used according to the label directions, it has a well-established record of safety and efficacy. Although acetaminophen overdose is very rare in the context of its broad usage, overdose can be toxic and lead to acute liver failure.

Liver injury from acetaminophen overdose remains a serious public health problem despite ongoing regulatory and educational efforts over the past several years to improve the safe use of medicines that contain acetaminophen. Patients can take too much if they take more than the labeled dose of one acetaminophen medicine, or if they take more than one medicine containing acetaminophen (for example, an OTC medicine that contains acetaminophen with a prescription medicine that contains acetaminophen).

To prevent acetaminophen overdose, consumers need to be able to read labels and recognize when their medicines contain acetaminophen. The active ingredients in OTC medicines are clearly listed on the label, but the container labels on prescription medicines that contain acetaminophen may not clearly identify acetaminophen as an active ingredient.

Under the leadership of the National Council for Prescription Drug Programs, FDA’s Safe Use Initiative and a broad group of stakeholders came together to form the Acetaminophen Best Practices Task Group, which produced the white paper, “NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen.”

These recommendations are intended to make it easier for consumers to: 1) identify that their prescription pain reliever contains acetaminophen, 2) compare active ingredients on their prescription and over-the-counter labels, and 3) take action to avoid taking two medicines with acetaminophen.

The recommendations advocate harmonizing the prescription container labeling with the labeling that already exists for OTC medicines that contain acetaminophen, providing consistency in labeling across all acetaminophen-containing medicines.

The White Paper recommends:

• Complete spelling of acetaminophen and all other active ingredients on the pharmacy labels of all acetaminophen-containing prescription medicine, eliminating the use of abbreviations, acronyms or other shortened versions for active ingredients
• A standardized concomitant use and liver pharmacy warning label for these medicines
• Formatting and wording on pharmacy container labels consistent with plain language and health literacy principles
• A stakeholder call to action: adopt, implement, adhere, communicate and educate

The Safe Use Initiative will continue to work with stakeholders to encourage adoption, implementation, and adherence to these recommendations, to address existing barriers and to encourage education and communication to improve the safe use of acetaminophen medicines.

In addition, the Safe Use Initiative will continue to initiate and participate in collaborative efforts and alternative strategies to help decrease unintentional overdose of acetaminophen-containing medicines.

For more, visit the FDA's Acetaminophen Information page.