US FDA has given 3 years’ time for drug manufacturers to limit the strength of paracetamol or acetaminophen in Rx only formulations, predominantly combinations of paracetamol & opioids, to 325 mg/dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with paracetamol.

A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain paracetamol.
Examples of such prescription products that include hydrocodone with paracetamol (Vicodin, Lortab), and oxycodone with paracetamol (Tylox, Percocet). OTC products containing paracetamol (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing paracetamol. FDA is continuing to evaluate ways to reduce the risk of paracetamol related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.
RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the paracetamol maximum total daily dose (4 grams/day), and not to drink alcohol while taking paracetamol-containing medications.
Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products.
Read the MedWatch safety alert, including links to the FDA Drug Safety Communication, Q&As, and Consumer Update here.

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