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- W2001364739 abstract "In their review of drugs with safety concerns due to QTc prolongation and torsades de pointes (TdP), Lin et al1 in Table I list “drugs that had been withdrawn or suspended from the market in at least 1 major regulatory territory because of an unacceptable risk of TdP.” Surprisingly, 2 opioids, propoxyphene and levacetylmethadol, withdrawn from the European and US markets are not mentioned. On November 19, 2010, the FDA MedWatch announced the withdrawal of the opioid propoxyphene because of cardiotoxicity, saying that “therapeutic doses increased the PR interval, widened the QRS complex and prolonged the QT interval causing serious and often fatal cardiac arrhythmias.”2 The withdrawal of dextropropoxyphene occurred in the European community in 2009.3 Levacetylmethadol (Orlaam [levomethadyl acetate]), an opioid similar in structure to methadone, approved by the Food and Drug Administration (FDA) in 1993 for the treatment of opioid dependence, was withdrawn from the European market in 2001 and from the US in 2003 because of reports of “life threatening ventricular rhythm disorders.”4 The propensity of methadone for QTc prolongation and TdP is well known.5,6 As such, an FDA Advisory Panel has recommended that pharmaceutical manufacturers institute a mandatory training for opioid prescribing called REMS (Risk Evaluation and Mitigation Strategy).7 Omission mentioning these cardiotoxic opioid hazards is of particular concern with methadone deaths increasing in the United States.8" @default.
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- W2001364739 date "2012-10-01" @default.
- W2001364739 modified "2023-10-18" @default.
- W2001364739 title "Opioids, QTc Prolongation, and Torsades" @default.
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- W2001364739 doi "https://doi.org/10.1177/0091270011422816" @default.
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