On Aug. 5, 2021, Gilead Sciences, Inc. (Gilead) issued a Company Statement warning of tampered and/or counterfeit versions of HIV treatment regimen Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and HIV treatment and prevention medicine Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) in circulation in the U.S. Gilead is working with the U.S. Food and Drug Administration (FDA), pharmacies, and legal authorities to remove tampered and/or counterfeit medicines from circulation and to prevent further distribution. The Company Statement includes information to determine whether dispensed Biktarvy and Descovy are authentic, and sets forth the following instructions on reporting potentially tampered and/or counterfeit medicines:
- Individuals who believe they have been dispensed a counterfeit and/or tampered Gilead medicine should immediately report the medicine to their doctor and pharmacy and Gilead Product Quality Complaints (1-800-445-3235, Option #2; QualityComplaints@gilead.com).
- If an individual is experiencing any side effects that they believe may be related to a Gilead medicine or to the use of a counterfeit drug, that person should immediately contact their health care provider and is additionally encouraged to report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch) or Gilead (1-800-445-3235, Option #3).
- Websites selling counterfeit and/or tampered medicines may be reported to the FDA.
- Health care professionals are encouraged to report anyone who solicits the sale of suspect drug products by emailing DrugSupplyChainIntegrity@fda.hhs.gov and by calling the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 or a local OCI field office.
Photo courtesy of Gilead.