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Posted On: 07/04/2020 11:23:34 AM
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dj FDA findings on hydroxychloroquine and chloroquine in the setting of coronavirus:
The purpose of this review is for the Division of Pharmacovigilance II (DPV II) to provide the Division of Antiviral (DAV) Drug Products a high-level overview of the postmarketing safety data related to the use of hydroxychloroquine and chloroquine in the setting of coronavirus
disease 2019 (COVID-19). The data reviewed for this evaluation were fromthe FDA Adverse Event Reporting System (FAERS) database, published medical literature, American Association of Poison Control Centers National Poison Data System (AAPPC-NPDS), and other safety reports forwarded from DAV.a
https://www.accessdata.fda.gov/drugsatfda_doc...dacted.pdf
hydroxychloroquine Key Findings:
• The majority of the cases (69%) involved males with a median age in the early 60s.
• Of the 385 cases reporting use of hydroxychloroquine or chloroquine in the setting of COVID-19, 377 cases reported use for treatment and 8 cases reported use for prophylaxis.
• 28% of the cases were from the U.S. Of the 97 U.S. cases for hydroxychloroquine, 5 reported use of hydroxychloroquine through the EUA.
• Eleven cases reported both a cardiac and non-cardiac AE.
• Of all serious adverse events (cardiac and non-cardiac), QT prolongation was the most commonly reported adverse event for both hydroxychloroquine and chloroquine.
• Of the 109 hydroxychloroquine and chloroquine cases with a serious cardiac adverse event:
o 80 (73%) reported QT prolongation.
o 4 (4%) reported Torsades de Pointes (TdP)
o 92 (84%) reported concomitant use of at least one other medication that prolongs
the QT interval. 75 (69%) reported concomitant use of azithromycin.
o 14 (13%) reported ventricular arrhythmia, ventricular tachycardia or ventricular fibrillation.
o 25 (23%) had a fatal outcome. Fatal cardiac cases were considered those cases reporting death and a cardiac AE.
9/25 had a cardiac event that was assessed to have possibly or probably
contributed to death.
22/25 reported use of a concomitant QT-prolonging medication.
The purpose of this review is for the Division of Pharmacovigilance II (DPV II) to provide the Division of Antiviral (DAV) Drug Products a high-level overview of the postmarketing safety data related to the use of hydroxychloroquine and chloroquine in the setting of coronavirus
disease 2019 (COVID-19). The data reviewed for this evaluation were fromthe FDA Adverse Event Reporting System (FAERS) database, published medical literature, American Association of Poison Control Centers National Poison Data System (AAPPC-NPDS), and other safety reports forwarded from DAV.a
https://www.accessdata.fda.gov/drugsatfda_doc...dacted.pdf
hydroxychloroquine Key Findings:
• The majority of the cases (69%) involved males with a median age in the early 60s.
• Of the 385 cases reporting use of hydroxychloroquine or chloroquine in the setting of COVID-19, 377 cases reported use for treatment and 8 cases reported use for prophylaxis.
• 28% of the cases were from the U.S. Of the 97 U.S. cases for hydroxychloroquine, 5 reported use of hydroxychloroquine through the EUA.
• Eleven cases reported both a cardiac and non-cardiac AE.
• Of all serious adverse events (cardiac and non-cardiac), QT prolongation was the most commonly reported adverse event for both hydroxychloroquine and chloroquine.
• Of the 109 hydroxychloroquine and chloroquine cases with a serious cardiac adverse event:
o 80 (73%) reported QT prolongation.
o 4 (4%) reported Torsades de Pointes (TdP)
o 92 (84%) reported concomitant use of at least one other medication that prolongs
the QT interval. 75 (69%) reported concomitant use of azithromycin.
o 14 (13%) reported ventricular arrhythmia, ventricular tachycardia or ventricular fibrillation.
o 25 (23%) had a fatal outcome. Fatal cardiac cases were considered those cases reporting death and a cardiac AE.
9/25 had a cardiac event that was assessed to have possibly or probably
contributed to death.
22/25 reported use of a concomitant QT-prolonging medication.
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