The World Health Organization (WHO) has issued a warning on a fraudulent medication that is purportedly being marketed in Turkey and India. According to the international health organization, “This WHO Medical Product Alert relates to one tampered-with batch of DEFITELIO (defibrotide sodium).” This fake product, which was provided outside of authorized and controlled channels, has been found in India and Turkey. The real DEFITELIO producer has acknowledged that the item included in the notice is a fake, according to the UN health agency. Genuine DEFITELIO with a Lot 20G20A was packaged in German/Austrian packaging, according to the original manufacturer. The counterfeit product does not adhere to the registered shelf life. There is no connection between the provided serial number and batch 20G20A. In Turkey and India, the medicine does not have a marketing authorization.
The WHO has already warned against the use of the specific medicine. WHO discovered the phony medication on May 7, 2020, in nations including Saudi Arabia, Australia, Argentina, Latvia, Malaysia, and Malaysia. In haemapoietic stem-cell transplant therapy, the medicine is approved for the treatment of severe hepatic veno-occlusive disease, commonly known as sinusodial obstructive syndrome.
The use of counterfeit DEFITELIO will result in inadequate patient care, may present additional significant dangers to health due to its intravenous delivery, and may even be life-threatening in some situations, according to the Global Health Agency. The statement added that “the safety, sterility, and quality of the falsified products referenced in this alert are unknown,” adding that “at this time, it is not aware of any reports of adverse events following the use of this reported falsified DEFITELIO.”
The occurrence should be reported by healthcare practitioners to the National Regulatory Authorities/National Pharmacovigilance Center. If national regulatory or health authorities discover these fake items, they are recommended to alert WHO right once.
Conclusion:-
The World Health Organization (WHO) has issued a warning on a fraudulent batch of DEFITELIO (defibrotide sodium) being marketed in Turkey and India. The fake product, which was provided outside authorized channels, does not adhere to the registered shelf life and has no connection between the provided serial number and batch 20G20A. The WHO has already warned against the use of the specific medicine, which is approved for treating severe hepatic veno-occlusive disease. The use of counterfeit DEFITELIO could result in inadequate patient care, significant health risks due to intravenous delivery, and even life-threatening situations. The WHO is not aware of any reports of adverse events following the use of the falsified DEFITELIO. Healthcare practitioners should report the occurrence to the National Regulatory Authorities/National Pharmacovigilance Center.
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