Drug alert: WHO issues urgent Alert over fake liver drug in India and Turkey

September 5, 2023

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Last Updated on October 6, 2024 by The Health Master

Drug alert

The World Health Organization (WHO) has raised a drug alert concerning a fake drug, DEFITELIO (defibrotide), purportedly distributed in India and Turkey.

This alarming revelation underscores the critical importance of ensuring the authenticity of medical products, as counterfeits can endanger lives and undermine public health efforts.

The Counterfeit Discovery:

WHO’s Medical Product Alert targets a single counterfeit batch of DEFITELIO (defibrotide sodium) that emerged in India in April 2023 and later in Turkey in July 2023.

The agency emphasizes that this falsified product surfaced outside the bounds of regulated and authorized distribution channels.

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DEFITELIO’s Purpose:

A key component of hemopoietic stem-cell transplantation (HSCT) therapy is DEFITELIO, a drug used to treat severe hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome (SOS).

It is designed to be administered to adults, adolescents, children, and infants over one month of age.

VOD is a condition characterized by the blockage of liver veins, hampering the liver’s normal functioning.

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Warning Signs of the Fake DEFITELIO:

According to WHO, the genuine manufacturer of DEFITELIO has confirmed the falsification of the product, highlighting several red flags:

Packaging Discrepancy: Authentic DEFITELIO (Lot 20G20A) comes in German/Austrian packaging, whereas the counterfeit versions sport UK or Irish packaging.
Expired Shelf Life: The stated expiration date on the counterfeit product is falsified and does not align with the registered shelf life.
Inaccurate Serial Number: The serial number on the counterfeit drug does not match batch 20G20A.
Lack of Marketing Authorization: The falsified DEFITELIO lacks proper marketing authorization in India and Turkey.

Past Alerts and Global Impact:

This isn’t the first time WHO has issued alerts regarding counterfeit DEFITELIO. Previous reports have highlighted this issue in other countries and regions as well.

The dissemination of fake medical products poses a severe risk to patient health and treatment efficacy.

Life-Threatening Consequences:

The use of counterfeit DEFITELIO can have dire consequences.

Given that it is administered intravenously, the fake drug may render treatment ineffective and even life-threatening in certain situations.

WHO stresses that, at present, no adverse events have been reported following the use of this counterfeit DEFITELIO.

Nevertheless, the safety, sterility, and quality of these fraudulent products remain uncertain.

Urgent Action Required:

WHO underscores the necessity for healthcare professionals to promptly report any incidents involving counterfeit DEFITELIO to National Regulatory Authorities or National Pharmacovigilance Centers.

National regulatory and health authorities are urged to inform WHO immediately upon identifying these falsified products.

In conclusion, the emergence of counterfeit DEFITELIO in India and Turkey serves as a stark reminder of the ongoing battle against fraudulent medical products.

Vigilance and swift action by healthcare professionals and regulatory bodies are essential to safeguarding public health and ensuring that patients receive genuine, life-saving treatments.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.