Consultant Pharmacist wearing surgical mask - Post Content: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19
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FDA Cautions Against Use of Hydroxychloroquine or Chloroquine for COVID-19

The Food and Drug Administration (FDA) recently cautioned against the use of hydroxychloroquine or chloroquine for the treatment of COVID-19 outside of a hospital setting or clinical trial.

Hydroxychloroquine or chloroquine are both approved for the treatment of malaria and additionally, hydroxychloroquine is also indicated for the treatment of autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.  Since the FDA issued the Emergency Use Authorization to allow these medications to be used in hospitalized patients with COVID-19, these medications have been used outside of this setting, despite a lack of evidence on safety and efficacy.

The FDA is concerned these medications are being used in unapproved ways to treat or try to prevent COVID-19.  These medications used alone or in combination with azithromycin or other medications that prolong QT interval may lead to potentially serious heart rhythm issues that can be life threatening.  This includes, QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases death.

What the FDA recommends for patients:

If patients are taking hydroxychloroquine or chloroquine to treat malaria or autoimmune conditions, they should continue taking their medication as prescribed.

Be aware, currently, there are no proven treatments for COVID-19 and no vaccine.

Consumers should not take any form of chloroquine that has not been prescribed for them by a healthcare professional.

What the FDA recommends for healthcare professionals:

When using hydroxychloroquine or chloroquine under the EUA or in clinical trials that investigate these medicines for the treatment or prevention of COVID-19, perform an initial evaluation and monitoring.  Monitoring may include baseline ECG, electrolytes, renal function and hepatic tests.

Be aware that hydroxychloroquine or chloroquine can:

  • cause QT prolongation
  • increase the risk of QT prolongation in patients with renal insufficiency or failure
  • increase insulin levels and insulin action causing increased risk of severe hypoglycemia
  • cause hemolysis in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
  • interact with other medicines that cause QT prolongation even after discontinuing the medicines due to their long half-lives of approximately 30-60 days

The FDA is continuing to investigate these risks and will provide more guidance when it is available.  They are asking patients and healthcare providers to report side effects via the FDA MedWatch Program.   If you have additional questions or are unsure what to do, please contact us and we will guide you.

The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centers, senior care facilities and pharmacies We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.

 

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