FDA Announces Alert of Potential Risks Associated with Compounding of Remdesivir

The U.S. Food and Drug Administration (FDA) approved a new drug application (NDA) for Veklury (remdesivir), a drug indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization on October 22, 2020. The Veklury approval includes two presentations: remdesivir for injection, 100 milligrams (mg), a sterile, preservative-free lyophilized powder and remdesivir injection, 100 mg/20 milliliters (mL) (5 mg/mL), a sterile, preservative-free solution. Veklury is an injectable drug and should only be administered in a hospital or in a health care setting capable of providing acute care comparable to inpatient hospital care. Important information about using Veklury to treat COVID-19 for its approved use is available in the prescribing information which includes dosing instructions, potential side effects and drug interactions. Possible side effects include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.

FDA understands that some compounders might be interested in compounding remdesivir drug products. However, FDA cautions against compounding remdesivir drug products and recommends that health care providers utilize the FDA-approved drug for patients who are prescribed remdesivir.

The agency reminds health care providers that compounded drugs are not FDA-approved and are not evaluated by FDA for safety, effectiveness or quality. Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.