Rapid Alert: Drug Product; Falsified Defitelio Infusion  identified in the WHO Regions of Europe and the Eastern Mediterranean

Rapid Alert

WHO Medical Product Alert N°3/2023 On Falsified DEFITELIO (defibrotide sodium)

DRAP Alert NoNo  I/S/06-23-25
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics, etc.
3. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
4. Patients, Caregivers, and General Public.
Problem StatementWHO issued Medical Product Alert No. 3/2023 on falsified batch No. 19G19A, Expiry Date 01/2025, of DEFITELIO identified in the United Arab Emirates and publically reported by the national regulatory authority (in November 2022). The falsified batch was also identified in Kyrgyzstan (in March 2023). They have been identified in UK/Ireland packaging and US packaging. This falsified product is not registered in Pakistan.
The genuine manufacturer of DEFITELIO has confirmed that the products referenced in WHO alert are falsified. Lab analysis of a sample of falsified products found it did not contain any of the stated active ingredients. The genuine manufacturer has also advised that:
    i.  Stated batch number 19G19A is not a genuine DEFITELIO batch number
    ii.   Expiry dates are falsified
    iii.   Falsified US pack with batch 19G19A / Exp. 01/2025- the vial inside the pack has a different batch number- M06B466E which is not a genuine batch number.
Therapeutic Goods Affected:-DEFITELIO 80 mg/ml Concentrate for Infusion
Active Ingredient: (Defibrotide Sodium)
Registration No.: Nil
Batch No. Outer carton Batch: 19G19A Exp. date: 01/2025 and Inner vial Batch: M06B466E
Purported Manufacturer (as per label) M/s. Gentium SRl

For further information please click for details of the affected products.
Risk StatementDEFITELIO (Defibrotide sodium) is an antithrombotic agent used to treat severe venous-occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic (blood) stem cell transplantation.
·         Use of falsified products will compromise the treatment of disease and may intensify the existing condition.
·         It may lead to life-threatening reactions due to intravenous administration as safety, sterility and quality of product are unknown.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate the batch of products if available. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this batch product. The remaining stock should be quarantined immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) in order to ensure the removal of these products.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

-Pharmacists and procurement officers present at healthcare facilities are requested to remain vigilant and inform patients of procuring medical products only from authorized channels.

-Adverse reactions or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersTo ensure authenticity, consumers should always obtain medical products from authorized licensed pharmacies /outlets. The authenticity of these products should be carefully checked and If the consumer has any doubt, advice must be sought from your pharmacist.

In case a consumer has experienced any problem related to taking or using these drug product(s), they should cease the use of the product in question immediately and contact their Physician or Pharmacist and should also report the incident to the Drug Regulatory Authority of Pakistan.