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10.1016/j.sapharm.2020.04.016

http://scihub22266oqcxt.onion/10.1016/j.sapharm.2020.04.016
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32327397!7166303!32327397
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suck abstract from ncbi


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pmid32327397      Res+Social+Adm+Pharm 2021 ; 17 (2): 483-486
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  • Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine #MMPMID32327397
  • Sarayani A; Cicali B; Henriksen CH; Brown JD
  • Res Social Adm Pharm 2021[Feb]; 17 (2): 483-486 PMID32327397show ga
  • BACKGROUND: Combinations of hydroxychloroquine (HCQ) and azithromycin have been promoted as treatments for COVID-19 based on small, uncontrolled clinical trials that have not assessed potential risks. Risks of treatment include QT segment prolongation, Torsades de Pointes (TdP), and death. This comparative pharmacovigilance analysis evaluated the risk of these events. METHODS: Data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) (>13 million total reports) were used. Queries extracted reports based on exposures of HCQ/chloroquine (CQ) alone, azithromycin alone, HCQ/CQ + azithromycin, amoxicillin alone, HCQ/CQ + amoxicillin alone. Amoxicillin served as a control. Events of interest included death and TdP/QT prolongation as well as accidents/injuries and depression as control events. Proportional Reporting Ratios (PRR) and 95% confidence intervals (CI) were calculated where a lower limit of the of 95% CI (Lower95CI) value of >/=2.0 is interpreted as a potential safety signal. RESULTS: Lower95CIs for HCQ/CQ alone showed no potential safety signals for TdP/QT prolongation, death, or any of the control events included. The PRRs and 95% CIs for TdP/QT prolongation was 1.43 (1.29-2.59) with HCQ/CQ use alone and 4.10 (3.80-4.42) for azithromycin alone. For the combined HCQ/CQ + azithromycin group, the PRR and 95% CI was 3.77 (1.80-7.87). For the control of amoxicillin, there were no safety signals when used alone or in combination with HCQ/CQ. CONCLUSIONS: HCQ/CQ use was not associated with a safety signal in this analysis of FAERS data. However, azithromycin used alone was associated with TdP/QT prolongation events and should be used with caution.
  • |Antiviral Agents/adverse effects/*therapeutic use[MESH]
  • |Azithromycin/adverse effects/*therapeutic use[MESH]
  • |COVID-19 Drug Treatment[MESH]
  • |COVID-19/complications[MESH]
  • |Chloroquine/adverse effects/*therapeutic use[MESH]
  • |Drug Interactions[MESH]
  • |Drug Therapy, Combination[MESH]
  • |Humans[MESH]
  • |Hydroxychloroquine/adverse effects/*therapeutic use[MESH]
  • |Long QT Syndrome/*chemically induced/mortality[MESH]
  • |Pharmacovigilance[MESH]
  • |Torsades de Pointes/*chemically induced/mortality[MESH]


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