Acetaminophen
INJECTION PRODUCTS
Risk of Medication Errors
Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:
the dose in milligrams (mg) and milliliters (mL) is not confused;
the dosing is based on weight for patients under 50 kg;
infusion pumps are properly programmed; and
the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.
Hepatotoxicity
- Acetaminophen for Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than one acetaminophen-containing product (see WARNINGS).
ORAL PRODUCTS; OPIOID CONTAINING MEDICATIONS
Risk Evalutation and Mitigation Strategy (REMS)
Hepatotoxicity
- Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product.
- Refer to specific product package insert for acetaminophen combination products
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
- Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to:
- complete a REMS-compliant education program,
- counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
- emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
- consider other tools to improve patient, household, and community safety.
Life Threatening Respiratory Depression in Medications Containing Opioids
- Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper.
FDA and Industry Communications
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information
Package Inserts
Acetaminophen
Acetaminophen/Codeine
Acetaminophen/Oxycodone
Acetaminophen/Hydrocodone
Acetaminophen/Tramadol
Acetaminophen/Butalbital/Caffeine/Codeine
This list is not inclusive of all acetaminophen combination products. Acetaminohpen content/amount should be considered when prescribing such products.