title: 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 aims of this article are to: 1) provide a summary and epidemiologic critique of the studies and evidence the FDA advisory committee reviewed; 2) examine the potential consequences, such as poorly managed pain or a shift to treatment with other medications with greater potential toxicity and/or restricted availability, if the FDA follows the advisory committee vote; and 3) outline alternate strategies the FDA should consider for reducing hepatotoxicity associated with opioid/acetaminophen combination products.
authors.affiliation: Brigham & Women's Hospital, 850 Boylston Street, Chestnut Hill, MA 02467, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Michna
authors.forename: Mei Sheng
authors.initials: MS
authors.lastname: Duh
authors.forename: Caroline
authors.initials: C
authors.lastname: Korves
authors.forename: June L
authors.initials: JL
authors.lastname: Dahl
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects*; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects*; D000701:Analgesics, Opioid / Q000009:adverse effects*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology*; D017281:Cost of Illness; D004338:Drug Combinations; D006801:Humans; D017114:Liver Failure, Acute / Q000139:chemically induced / Q000453:epidemiology; D057051:Product Recalls and Withdrawals; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D000082:Acetaminophen