2010
DOI: 10.1111/j.1526-4637.2010.00811.x
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Removal of Opioid/Acetaminophen Combination Prescription Pain Medications: Assessing the Evidence for Hepatotoxicity and Consequences of Removal of These Medications

Abstract: Opioid/acetaminophen combination products are widely prescribed for the management of moderate to moderately severe pain. Acetaminophen, when improperly used, can lead to liver damage and even acute liver failure. In June 2009, an FDA advisory committee recommended elimination of prescription acetaminophen combination products because of the risk of hepatotoxicity associated with use of these medications. The FDA advisory committee reviewed numerous observational studies and adverse event reporting data. The a… Show more

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Cited by 47 publications
(39 citation statements)
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“…[20,28-30] However, only a few population level studies, all using American data, [31,32] have documented the prevalence of paracetamol use exceeding the dosage limits recommended by regulatory bodies. The objective of this study is to provide population-based Canadian data on the prevalence of high-dose paracetamol use from prescribed paracetamol/opioid combinations.…”
Section: Introductionmentioning
confidence: 99%
“…[20,28-30] However, only a few population level studies, all using American data, [31,32] have documented the prevalence of paracetamol use exceeding the dosage limits recommended by regulatory bodies. The objective of this study is to provide population-based Canadian data on the prevalence of high-dose paracetamol use from prescribed paracetamol/opioid combinations.…”
Section: Introductionmentioning
confidence: 99%
“…Due to this growing concern, the US Food and Drug Administration (FDA) voted in 2009 to recommend elimination of prescription acetaminophen combination products. However, they subsequently revised this recommendation in 2011 to no more than 325 mg of acetaminophen in each combination tablet (Michna et al 2010;Blieden et al 2014). As of January 2014, over half of pharmaceutical manufacturers have complied with this recommendation and the FDA has urged physicians to avoid prescribing combination medications with >325 mg of acetaminophen per tablet (Blieden et al 2014).…”
mentioning
confidence: 99%
“…With approximately half of all acetaminophen-related hepatotoxicity caused by unintentional overdose and 63 % of these cases involving opioid combination products, there is growing concern over unintentional overdose with acetaminophen combination medications (Michna et al 2010). A recent report cited that 6 % of adults in the USA are currently being prescribed over 4 g/day of acetaminophen, largely due to combination medications (Blieden et al 2014).…”
mentioning
confidence: 99%
“…Practitioners prescribe combination products such as hydrocodone-acetaminophen more often than any other pain medication in certain populations, such as beneficiaries of the Medicare Part D Prescription Drug Program [18]. The use of acetaminophen as part of a multimodal pain treatment regimen may attenuate opioid-induced side effects, but it increases the risk of acetaminophen toxicity [19,20]. …”
Section: Discussionmentioning
confidence: 99%