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  5. Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment
  1. Medical Product Safety Information

Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment

[Posted 06/15/2020]

AUDIENCE: Health Professional, Pharmacy, Patient

ISSUE: FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.

The agency is not aware of instances of this reduced activity occurring in the clinical setting but, is continuing to evaluate all data related to remdesivir.

BACKGROUND: Following an evaluation of the emergency use authorization criteria and the scientific evidence available, the FDA issued an emergency use authorization (EUA) in May 2020 allowing for remdesivir to be distributed in the U.S. and to be administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and pediatric patients hospitalized with severe disease. The safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, and preliminary clinical trial results have shown that on average, patients treated with remdesivir had more rapid time to recovery.

RECOMMENDATION: It is recommended that health care providers read the most up-to-date fact sheet when prescribing remdesivir. These fact sheets include information on possible side effects such as: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and allergic reactions, which may include low blood pressure, high heart rate, low heart rate, shortness of breath, wheezing, angioedema (for example, lip or tongue swelling), difficulty swallowing, rash, nausea, vomiting, sweating, shivering and respiratory distress.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form or submit by fax to 1-800-FDA-0178

[06/15/2020 - Press Release - FDA]

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