DRAP issues alert over falsified blood cancer medicines

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has issued a rapid alert after several batches of two medicines commonly used to treat blood cancer were found to be counterfeit and potentially dangerous to patients.

According to DRAP, the alert follows Medical Product Alerts issued by the World Health Organization (WHO) regarding falsified DARZALEX (Daratumumab) Injection and JAKAVI (Ruxolitinib) Tablets detected in multiple WHO regions.

DRAP said falsified DARZALEX (Daratumumab) Injection was identified in the WHO Regions of the Americas and South-East Asia, while falsified JAKAVI® (Ruxolitinib) tablets were detected in the WHO Eastern Mediterranean and European Regions.

The counterfeit DARZALEX products were found in the Maldives and Mexico after being supplied through unauthorized distributors, with at least one report indicating that the products had reached hospitals.

The genuine manufacturer, Janssen, has confirmed that the following batch numbers are not authentic and any DARZALEX product bearing these numbers should be considered falsified:

DARZALEX (Daratumumab) Injection 400 mg/20 mL — Batch No. STV1K01
DARZALEX (Daratumumab) Injection 100 mg/5 mL — Batch No. MYS7381

DARZALEX (daratumumab) is a monoclonal antibody used to treat multiple myeloma and amyloid light-chain (AL) amyloidosis.

DRAP said no laboratory testing has been carried out on the falsified products, and their identity, composition, quality, and sterility remain unknown. The counterfeit medicines may contain no active ingredient, incorrect ingredients, or harmful substances, making them ineffective or potentially dangerous.

DO NOT use these syringes, DRAP issues alert

WHO has also reported visible particulate matter in one falsified batch (STV1K01), indicating a possible risk of contamination. Use of these products may lead to treatment failure, disease progression, infections, injection-related complications, increased morbidity, and potentially life-threatening outcomes.

Meanwhile, falsified JAKAVI (Ruxolitinib) tablets were detected in Iran, Türkiye, and the Russian Federation after being illegally sold through online platforms and, in at least one case, supplied through a pharmacy.

The genuine manufacturer, Novartis Pharma AG, has confirmed that the following batch numbers are not genuine and should be considered falsified:

JAKAVI® (Ruxolitinib) Tablets 20 mg — Batch No. AVT50
JAKAVI® (Ruxolitinib) Tablets 15 mg — Batch No. FNR06
JAKAVI® (Ruxolitinib) Tablets 15 mg — Batch No. SGL04

DRAP has directed its Regulatory Field Force and the Provincial Drug Control Departments to intensify surveillance across the pharmaceutical supply chain and confiscate any falsified products found in the market.