{"id":23710,"date":"2023-04-17T04:50:00","date_gmt":"2023-04-16T20:50:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=23710"},"modified":"2023-04-17T05:42:40","modified_gmt":"2023-04-16T21:42:40","slug":"jama%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9afda%e9%99%90%e5%88%b6%e5%af%b9%e4%b9%99%e9%85%b0%e6%b0%a8%e5%9f%ba%e9%85%9a%e4%b8%8e%e9%98%bf%e7%89%87%e8%81%94%e5%90%88%e5%a4%84%e6%96%b9%e7%9a%84","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=23710","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1aFDA\u9650\u5236\u5bf9\u4e59\u9170\u6c28\u57fa\u915a\u4e0e\u963f\u7247\u8054\u5408\u5904\u65b9\u7684\u547d\u4ee4\u53ca\u968f\u540e\u4f4f\u9662\u53ca\u6025\u6027\u809d\u8870\u7684\u76f8\u5173\u6027"},"content":{"rendered":"\n

Original Investigation <\/p>\n\n\n\n

March 7, 2023<\/p>\n\n\n\n

Association of FDA Mandate Limiting Acetaminophen (Paracetamol) in Prescription Combination Opioid Products and Subsequent Hospitalizations and Acute Liver Failure<\/h1>\n\n\n\n

Babak J.\u00a0Orandi,\u00a0M. Chandler\u00a0McLeod,\u00a0Paul A.\u00a0MacLennan,\u00a0et al<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>2023;329(9):735-744. doi:10.1001\/jama.2023.1080<\/h3>\n\n\n\n

Key Points<\/p>\n\n\n\n

Question<\/strong>  Was the US Food and Drug Administration (FDA) mandate to limit acetaminophen (paracetamol) to 325 mg\/tablet in prescription combination acetaminophen and opioid medications associated with a decrease in hospitalizations for acetaminophen and opioid toxicity and a decline in the proportion of acute liver failure (ALF) hospitalizations due to acetaminophen and opioid toxicity?<\/p>\n\n\n\n

Findings<\/strong>  In this interrupted time series analysis, there was a significant decline in the yearly rate of hospitalizations involving acetaminophen and opioid toxicity and a significant decrease in the proportion per year of hospitalizations due to ALF with acetaminophen and opioid toxicity after the FDA mandate.<\/p>\n\n\n\n

Meaning<\/strong>  The FDA mandate to limit acetaminophen to 325 mg\/tablet in prescription combination acetaminophen and opioid medications was associated with a decline in hospitalizations involving acetaminophen and opioid toxicity and a decrease in the proportion of ALF hospitalizations due to acetaminophen and opioid toxicity.<\/a><\/p>\n\n\n\n

Abstract<\/p>\n\n\n\n

Importance<\/strong>  In January 2011, the US Food and Drug Administration (FDA) announced a mandate to limit acetaminophen (paracetamol) to 325 mg\/tablet in combination acetaminophen and opioid medications, with manufacturer compliance required by March 2014.<\/p>\n\n\n\n

Objective<\/strong>  To assess the odds of hospitalization and the proportion of acute liver failure (ALF) cases with acetaminophen and opioid toxicity prior to and after the mandate.<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>  This interrupted time-series analysis used hospitalization data from 2007-2019 involving ICD-9<\/em>\/ICD-10<\/em> codes consistent with both acetaminophen and opioid toxicity from the National Inpatient Sample (NIS), a large US hospitalization database, and ALF cases from 1998-2019 involving acetaminophen and opioid products from the Acute Liver Failure Study Group (ALFSG), a cohort of 32 US medical centers. For comparison, hospitalizations and ALF cases consistent with acetaminophen toxicity alone were extracted from the NIS and ALFSG.<\/p>\n\n\n\n

Exposures<\/strong>  Time prior to and after the FDA mandate limiting acetaminophen to 325 mg in combination acetaminophen and opioid products.<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>  Odds of hospitalization involving acetaminophen and opioid toxicity and percentage of ALF cases from acetaminophen and opioid products prior to and after the mandate.<\/p>\n\n\n\n

Results<\/strong>  In the NIS, among 474\u202f047\u202f585 hospitalizations from Q1 2007 through Q4 2019, there were 39\u202f606 hospitalizations involving acetaminophen and opioid toxicity; 66.8% of cases were among women; median age, 42.2 (IQR, 28.4-54.1). In the ALFSG, from Q1 1998 through Q3 2019, there were a total of 2631 ALF cases, of which 465 involved acetaminophen and opioid toxicity; 85.4% women; median age, 39.0 (IQR, 32.0-47.0). The predicted incidence of hospitalizations 1 day prior to the FDA announcement was 12.2 cases\/100\u202f000 hospitalizations (95% CI, 11.0-13.4); by Q4 2019, it was 4.4\/100\u202f000 hospitalizations (95% CI, 4.1-4.7) (absolute difference, 7.8\/100\u202f000 [95% CI, 6.6-9.0]; P<\/em>\u2009<\u2009.001). The odds of hospitalizations with acetaminophen and opioid toxicity increased 11%\/y prior to the announcement (odds ratio [OR], 1.11 [95% CI, 1.06-1.15]) and decreased 11%\/y after the announcement (OR, 0.89 [95% CI, 0.88-0.90]). The predicted percentage of ALF cases involving acetaminophen and opioid toxicity 1 day prior to the FDA announcement was 27.4% (95% CI, 23.3%-31.9%); by Q3 2019, it was 5.3% (95% CI, 3.1%-8.8%) (absolute difference, 21.8% [95% CI, 15.5%-32.4%]; P<\/em>\u2009<\u2009.001). The percentage of ALF cases involving acetaminophen and opioid toxicity increased 7% per year prior to the announcement (OR, 1.07 [95% CI, 1.03-1.1]; P<\/em>\u2009<\u2009.001) and decreased 16% per year after the announcement (OR, 0.84 [95% CI, 0.77-0.92]; P<\/em>\u2009<\u2009.001). Sensitivity analyses confirmed these findings.<\/p>\n\n\n\n

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Conclusions and Relevance<\/strong>  The FDA mandate limiting acetaminophen dosage to 325 mg\/tablet in prescription acetaminophen and opioid products was associated with a statistically significant decrease in the yearly rate of hospitalizations and proportion per year of ALF cases involving acetaminophen and opioid toxicity.<\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation  March 7, 2023 As […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/23710"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=23710"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/23710\/revisions"}],"predecessor-version":[{"id":23711,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/23710\/revisions\/23711"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=23710"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=23710"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=23710"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}