Acetaminophen Position Statement

National Pain Foundation Position Statement on Acetaminophen Safety, FDA 2009N0138

The National Pain Foundation (NPF) is dedicated to improving the quality of life for those living with pain through information, education, and support that connects persons with pain to each other and to those that can help. Established by some of the country's foremost authorities on pain medicine and research, the NPF, a non-profit 501(c)(3) organization, has been building a legacy of compassion to people in pain, their caregivers, family members and health care providers.

The NPF believes that acetaminophen is a safe and effective medication for relieving pain and reducing fever when used as directed. The NPF recommends that patients always follow our Five Tips for Taking Acetaminophen guidelines to ensure they take acetaminophen safely.

Five Tips for Taking Acetaminophen

1. Do not exceed the recommended single dose and total daily dose of acetaminophen.
2. Be aware that many over-the-counter (OTC) and prescription medications contain acetaminophen and that the label “APAP” on prescriptions is shorthand for acetaminophen.
3. It is up to you to calculate how much acetaminophen you are taking, especially if both OTC and prescription drugs are being used at the same time. Be especially careful in calculating doses for infants and children.
4. Keep acetaminophen products safely away from children and adults with impaired thinking (e.g., dementia).
5. If you have chronic kidney or liver disease, consult with your health care provider before using acetaminophen.

Patient education is key to keeping patients safe. To better educate patients about their medications and treatment options, the NPF has created PainSAFE - Pain Safety & Access For Everyone, an educational initiative for patients, health care providers, pharmacists and the public to ensure the safe use of medications and other pain therapies while protecting access to care. PainSAFE provides solutions to help save lives and reduce injuries related to pain therapies while ensuring that pain care options remain accessible for everyone.

Our PainSAFE campaign promotes patient safety and responsibility through education and awareness about proper drug medication use among patient and physician communities. PainSAFE’s focus is to alleviate suffering, provide education on safety and treatment options and improve pain care for the millions of Americans with pain.

The NPF supports the US Food and Drug Administration’s efforts to improve the safe use of acetaminophen. Acetaminophen is one of the most widely used and safest medications available to relieve pain and reduce fever when used appropriately. The NPF believes it is extremely important for patients and providers to be aware of the cumulative amount of acetaminophen patients are ingesting, as too much acetaminophen can be extremely dangerous, potentially causing liver damage or death if too much is ingested. The NPF supports efforts to promote safety and awareness related to acetaminophen use.

The National Pain Foundation believes:

• As a patient education and advocacy nonprofit organization, efforts to promote safety and awareness related to the safe use of acetaminophen are needed to keep patients safe.
• That greater patient, public and health care provider educational efforts are the best tool to increase patient safety while maintaining access to care.
• That patient safety and access to care issues must be balanced to deal effectively with medication safety issues.

The National Pain Foundation supports:

• Patient education efforts that focus on safety and safely ingesting acetaminophen.
• More prominent labeling of risks of overdose on the packaging of acetaminophen products.
• Changing all labels of products with acetaminophen to spell out “acetaminophen” so that products do not use APAP as an abbreviation.
• Significant public and patient education efforts funded by both branded and generic acetaminophen manufacturers that include:
  • Having third-party independent nonprofit organizations manage the education instead of the FDA or industry.
  • Maintaining a web site to link all information and education efforts on acetaminophen safety from public, professional and industry related information sites via the NPF.
• Mandating that a measuring device be included in each package of infant or children’s formulas containing acetaminophen.
• Promoting health care professional education for physicians, pharmacists and other providers.

The National Pain Foundation opposes:

• Actions that will limit patient access to care and/or move people to other products which may be less effective or more dangerous than acetaminophen.
• Requiring packaging of the pills in blister packs.
  • Blister packs can be very difficult to open for those with arthritis, fibromyalgia, Parkinson’s and other ailments.
• Eliminating all OTC products that contain acetaminophen along with other ingredients for a combination product.
  • It is more expensive for consumers to buy two products.
  • It creates more packaging waste, which is harmful to the environment.
  • Better package warnings and public education can prevent misuse or unintentional overdose without limiting many patients’ preference for combination products.
  • Many people, particularly older Americans, do not want to take more pills. This would increase that problem.
• Limiting the number of pills in a bottle.
  • Limiting the number of pills decreases access to pain relief.
  • This increases the cost to the patient and health care costs in general.
  • This creates more packaging waste which is harmful to the environment.
  • This does not prevent consumers from buying multiple packages.
• Reducing the maximum recommended dose.
  • Research indicates the current dosage is safe and also best for pain relief.