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FDA acts to limit exposure to acetaminophen in combination products

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g356 (Published 22 January 2014) Cite this as: BMJ 2014;348:g356
  1. Michael McCarthy
  1. 1Seattle

Healthcare providers should stop prescribing combination drug products that contain more than 325 mg of acetaminophen (paracetamol) per dosage unit because of the increased risk of liver injury, the US Food and Drug Administration has said.1

Many prescription drugs for pain on the market combine acetaminophen with an opioid, such as codeine, oxycodone, or hydrocodone. Such prescription products containing acetaminophen combinations make up 20% of the acetaminophen market and include some of the most widely prescribed drugs in the United States.

Inadvertent overdoses from acetaminophen combination products account for nearly half …

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