#NAFDAC Use of Chloroquine or Hydroxychloroquine for COVID-19 Clinical Trial Treatment: Risk of Heart Rhythm Problems


Posted on: Wed 06-05-2020

The National Agency for Food and Drug Administration and Control (NAFDAC), cautions Healthcare professionals that use Chloroquine or Hydroxychloroquine to treat patients with Coronavirus Disease (COVID-19) for clinical trial treatment due to risk of Heart Rhythm problems, especially in patients with underlying health issues. 

Serious heart-related adverse events in patients with COVID-19 receiving Chloroquine or Hydroxychloroquine either alone or combined with Azithromycin or other QT prolonging medicines had been reported. These adverse events included QT interval prolongation, ventricular tachycardia, ventricular fibrillation and in some cases death. 

Healthcare professionals are implored to only use chloroquine or Hydroxychloroquine in the context of clinical trials for the treatment of COVID-19. In addition, healthcare professionals are urged to: 

  • Ensure that patient receiving Chloroquine or Hydroxychloroquine for COVID-19 are adequately monitored to detect, document and report adverse Drug Reactions (ADRs) associated with the use of the medicines. 
  • Ensure that pre-existing heart problems that can make the  patients to be more prone to heart rhythm problems are properly documented during clinical trials. 
  • Report all concomitant medicines used in the management of OCVID-19 during clinical trials including Azithromcin. 
  • Enlighten patients with COVID-19 on expected and unexpected ADRs that may be association with Chloroquine or Hydroxychloroquine to enable the patients report their experiences with the use of the medicines. 

Healthcare professionals and patients are to report adverse event related to use of Chloroquine or Hydroxychloroquine or any other drug to the nearest NAFDAC office, 0800-1 NAFDAC (0800-1-623322) TOLL FREE from all networks or submit online at https://primaryreporting.who-umc.org/reporting/reporter?OrganizationID=NG or via [email protected]

NAFDAC… Customer focused, Agency minded 

Signed 

Management