FDA Issues New Draft Guidance for Products Containing Acetaminophen

Posted 03 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released new draft guidance pertaining to over-the-counter drug products containing acetaminophen, saying it will allow exceptions to a labeling rule under limited circumstances.

Acetaminophen is commonly used in internal analgesic, antipyretic and antirheumatic (IAAA) drugs to relieve pain, but had also been associated with liver injury and stomach bleeding if used at high dosages. As a result of the associated adverse events, FDA required product manufacturers to label IAAA products with the following label as the result of a 2009 final rule:

Liver warning: This product contains acetaminophen.  Severe liver damage may occur if you take

    • More than [insert maximum number of daily dosage units] in24 hours, which is the maximum daily amount [optional: "for this product"]
    • With other drugs containing acetaminophen 
    • 3 or more alcoholic drinks every day while using this product.

Because the first clause of this statement can be construed as being confusing-FDA said it is aware of concerns saying it "might be interpreted as indicating that severe liver damage is associated with a total daily dose of acetaminophen that is less than 4,000 mg"-FDA said it will "exercise enforcement discretion" in certain circumstances.

If the manufacturer believes the use of the above statement could cause confusion as it relates to its specific product, FDA has authorized an alternate statement:

Liver warning:  This product contains acetaminophen. Severe liver damage may occur if you take:

    • More than 4,000 mg of acetaminophen in 24 hours
    • With other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product.

While the changed wording was not authorized in the original regulation, FDA said its use of "enforcement discretion" is needed to mitigate "potential confusion." The alternate warning is not to be used for pediatric populations, which has a unique wording apart from the one in question.

Read more:

FDA - Guidance for Industry - Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use - Labeling for Products That Contain Acetaminophen

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