WHO Issues Global Alerts on Falsified Oncology Drugs JAKAVI and DARZALEX Found Across Five Countries
核心洞察
WHO issued two medical product alerts in June–July 2026 for falsified JAKAVI (ruxolitinib) and DARZALEX (daratumumab) detected across Iran, Russia, Türkiye, Maldives, and Mexico.
Laboratory analysis of falsified JAKAVI 20 mg confirmed complete absence of the active ingredient ruxolitinib, while falsified DARZALEX vials contained visible particulate matter signaling contamination risk.
Both falsified products reached patients through online platforms and, in some cases, through pharmacies and hospitals, posing risks of treatment failure, disease progression, and death.
The World Health Organization has issued two urgent medical product alerts following the discovery of falsified versions of two critical oncology drugs—JAKAVI (ruxolitinib) and DARZALEX (daratumumab)—in five countries across three continents. The alerts, published in June and July 2026, warn that these counterfeit products have reached patients through online platforms, pharmacies, and hospitals, posing potentially life-threatening risks to individuals with serious blood disorders and cancers.
Falsified JAKAVI: Three Batches, Zero Active Ingredient
WHO Medical Product Alert N°2/2026 concerns three batches of falsified JAKAVI (ruxolitinib) detected in the Islamic Republic of Iran, the Russian Federation, and Türkiye and reported to WHO in May 2026. JAKAVI, manufactured by Novartis, is used in oncology to treat certain serious blood diseases and complications following stem cell transplantation.
The genuine manufacturer confirmed that the batch numbers observed on the falsified products—AVT50, FNR06, and SGL04—are not valid. Any JAKAVI product bearing these batch numbers should be considered falsified and must not be used.
Laboratory analysis conducted by Novartis on a sample of falsified JAKAVI 20 mg from batch AVT50, identified in Türkiye, confirmed the complete absence of the stated active ingredient, ruxolitinib. Additionally, visual inspection revealed packaging discrepancies: blister strips from falsified cartons of batches AVT50 and SGL04 do not display a batch number.
The falsified products were illicitly sold to patients via online platforms and, in at least one instance, were also supplied to patients from a pharmacy.
Falsified DARZALEX: Contamination Risk from Visible Particulates
WHO Medical Product Alert N°3/2026 addresses two batches of falsified DARZALEX (daratumumab) injection detected in Maldives and Mexico. National Regulatory Authorities in both countries reported the incidents to WHO in May and June 2026. DARZALEX, a monoclonal antibody manufactured by Janssen, is used to treat multiple myeloma (搜索) and amyloid light-chain (AL) amyloidosis (搜索).
Janssen confirmed that the batch numbers MYS7381 and STV1K01 are not valid. The falsified products were supplied or offered by non-authorized distributors, and in at least one case, hospitals received these falsified products.
Critically, the Maldives Food and Drug Authority reported visible particulate matter in vials of falsified DARZALEX from batch STV1K01. No laboratory testing has been conducted on these products, and their contents, quality, and sterility remain unknown.
Patient Safety Risks
WHO warns that the use of these falsified products may pose significant risks to patient health. Since the falsified products have not undergone comprehensive laboratory analysis, they may contain no active ingredient, incorrect ingredients, or harmful substances.
For patients receiving falsified JAKAVI, the absence of ruxolitinib may lead to treatment failure, resulting in progression of serious disease and an increased risk of death due to lack of therapeutic effect. WHO notes that patients receiving JAKAVI often have weakened immune systems as a result of their condition, making them particularly vulnerable to ineffective or falsified products, which may result in rapid deterioration and severe clinical outcomes.
For falsified DARZALEX, the visible particulate matter signals a risk of contamination. Patients could face adverse reactions, including infections or injection-related complications. Patients receiving falsified DARZALEX may not get appropriate treatment for their condition, which can lead to disease progression and increased morbidity and mortality.
WHO Recommendations
WHO advises healthcare professionals to report any unusual adverse events, unexpected lack of therapeutic effects, or observed quality defects associated with JAKAVI or DARZALEX to their National Regulatory Authority or National Pharmacovigilance Centre.
The organization calls for increased surveillance and monitoring of the supply chain in countries and regions likely to be affected, with special emphasis on the informal and unregulated market, including online platforms. National regulatory authorities, health authorities, and law enforcement are advised to immediately notify WHO if these falsified products are detected in their country.
WHO emphasizes that all medical products must be obtained from authorized and licensed suppliers. Anyone in possession of these products should not use them, and individuals who may have used them or suffered adverse events should seek immediate medical advice. Information about the manufacture or supply of these products can be reported to WHO at rapidalert@who.int.