The World Health Organization (WHO) has urged caution following the discovery of fake batches of a cancer treatment drug named "Darzalex" in the Maldives.
In a medical product alert issued today, the WHO stated that these falsified medicines, which were detected in the Maldives and Mexico, pose a threat to patients' lives and could cause severe disruptions to treatment regimens.
According to the WHO, the greatest concern is that some hospitals have acquired this medicine. The organization stated that this is a worrying development regarding the international pharmaceutical supply chain.
"Darzalex" is an antibody used to treat multiple myeloma, a type of bone marrow cancer, as well as amyloidosis, a blood disorder.
This medicine plays an important role in the treatment of various types of cancer. Therefore, the WHO noted that the circulation of substandard versions of this drug could lead to delays in necessary patient care, treatment failure, and life-threatening outcomes.
The WHO has identified the batch numbers of these products, which have been deceptively placed on the market as genuine medical products. Citing Janssen, the manufacturer of the drug, the WHO stated that the batches bearing numbers MYS7381 and STV1K01 are not authentic.
Consequently, instructions have been given not to use the medicine bearing these specific numbers.
The Maldives Food and Drug Authority (MFDA) has also stated that visible particles or foreign substances were noticed inside some vials from these batches.
The WHO has urged regulatory authorities, healthcare professionals, and pharmaceutical wholesalers to further strengthen medicine safety protocols.
Furthermore, the WHO has advised countries to monitor pharmaceutical markets closely and to implement specific measures. In this regard, healthcare professionals have been instructed to immediately report to relevant authorities if a medicine is suspected to be counterfeit, if its use results in unusual adverse effects, or if the drug fails to produce the expected therapeutic effects.
The WHO also appealed to the public to acquire medicines only from licensed pharmacies and healthcare facilities. It further advised checking the outer cover and packaging of medicines thoroughly and seeking the advice of a healthcare professional if there is a change in the appearance of the drug or if it is suspected of being unauthentic.
Previously, the WHO has also issued warnings regarding falsified versions of other cancer treatment drugs, such as "Imfinzi," "Ibrance," and "Defitelio."
The WHO estimates that one in ten medical products in developing and developed nations is either substandard or falsified. The organization stated that this remains one of the greatest challenges facing global public health.
