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  • Medical Product Alert N°5/2020 – 7 May 2020

    Medical Product Alert N°5/2020 – 7 May 2020

    Falsified and contaminated Defibrotide identified in WHO regions of Western Pacific, Europe and Eastern Mediterranean

    This alert relates to falsified DEFIBROTIDE 200MG VIALS OF 2.5ML (80MG/ML) CONCENTRATE FOR SOLUTION FOR INFUSION identified in Australia, Latvia and Saudi Arabia. This product is sold under the brand name Defitelio.

    On 13 March 2020, the WHO Global Surveillance and Monitoring System on Substandard and Falsified (SF) Medical Products was informed that falsified DEFIBROTIDE 200MG vials were identified at patient level in Australia, displaying batch number 0286 (see Table 1 below for full details).

    Following enquiries with stakeholders, on 8 April 2020, WHO was informed that falsified DEFIBROTIDE 200MG vials had also been supplied to Saudi Arabia, displaying batch number 0286 and 0126 (see Table 1 below for full details).

    Following enquiries with stakeholders, on 9 April 2020, WHO was informed that falsified DEFIBROTIDE 200MG vials, displaying batch number 0126, had also been identified in Australia and Latvia.

    DEFIBROTIDE is used to treat hepatic veno-occlusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots. This can be caused by treatments prior to a stem cell transplantation.

    Laboratory analyses, conducted by national medicines regulatory authorities and the manufacturer of the genuine product, established that these falsified products do not contain any of the expected active ingredient. The solution in the vials is also contaminated with mould (Cladosporium sp. and Aspergillus niger).

    Information available to WHO indicates that both batches of falsified DEFIBROTIDE 200MG vials were present within the regulated supply chain in Latvia as early as January 2020 and were also handled by medicine wholesalers in the United Kingdom in February 2020. It is important to note that widespread vigilance is required from all countries, regardless of where the product was originally identified.

    Table 1: falsified defibrotide subject of WHO Alert n°5/2020, identified in Australia, Latvia and Saudi Arabia

    Medical Product Alert N°5/2020 - 7 May 2020 1

    The two products listed in Table 1 are confirmed falsified, on the basis that there is deliberate misrepresentation of their identity, composition and source.

    The genuine manufacturer of Defibrotide, GENTIUM S.R.L has also confirmed to WHO that:

    • They did not manufacture the above products.
    • Authentic DEFIBROTIDE 200MG VIALS with batch number 0286 were supplied to Argentina, Hong Kong, Malaysia, Singapore and Turkey.
    • Authentic DEFIBROTIDE 200MG VIALS with batch number 0126 were supplied to Australia, Jordan, Kuwait, Lebanon, New Zealand, Qatar, Singapore, Turkey and the United Arab Emirates. 

      For guidance and photographs, please refer to page 2 of this Alert n°5/2020.

    Photos of Falsified DEFIBROTIDE Batch number: 0286, with expiry date: 09/2021

    Medical Product Alert N°5/2020 - 7 May 2020 2         Medical Product Alert N°5/2020 - 7 May 2020 3
    Sample from Latvia       Sample from Latvia

    Photos of Falsified DEFIBROTIDE Batch number: 0126, with expiry date: 08/2021

    Medical Product Alert N°5/2020 - 7 May 2020 4           Medical Product Alert N°5/2020 - 7 May 2020 5
    Sample from Australia       Sample from Australia

    WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products.

    If you are in possession of the above products, please do not use them. If you have used these falsified products, or if you suffer an adverse reaction/event having used these products, you are advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre.

    All medical products must be obtained from licensed, authorized and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.

    National regulatory/health authorities are advised to immediately notify WHO if these falsified products are identified in their country(ies). If you have any information concerning the manufacture, distribution, or supply of these products, please contact rapidalert@who.int.

    WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products

    For further information, please visit our website: https://www.who.int/medicines/regulation/ssffc/en/ 

    Medical Product Alert N°5/2020 - 7 May 2020
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    https://www.who.int/news-room/detail/07-05-2020-medical-product-alert-n-5-2020

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  • UFC 249 postponed again

    UFC 249 postponed again

    UFC 249 postponed again 6

    LOS ANGELES: The Ultimate Fighting Championship on Thursday scrapped controversial plans to stage a fight card later this month as the United States battles the coronavirus pandemic.

    The mixed martial arts organisation had planned to hold UFC 249 without fans at an undisclosed location, reportedly an Indian tribal reservation in California.

    However in an abrupt U-turn on Thursday, UFC said it had postponed the event at the request of broadcasters ESPN.

    “While the organisation was fully prepared to proceed with UFC 249, ESPN has requested the postponement of the event and subsequent bouts until further notice in light of the COVID-19 pandemic,“ a UFC statement said.

    “UFC looks forward to resuming the full live events schedule as soon as possible.”

    The New York Times reported on Wednesday that UFC chief Dana White planned to hold the event at the Tachi Palace Resort Casino in central California on April 18.

    By staging the event on tribal land, the UFC could have sidestepped state guidelines aimed at halting the spread of COVID-19 infections that have brought sports to a standstill.

    However the move met with resistance from California Senator Dianne Feinstein, who urged the UFC to postpone.

    “This event would involve dozens of individuals flying to California and driving to a casino for a purpose no one can honestly claim is essential,“ Feinstein said in a statement.

    “Going ahead with this event is not the right move.”

    The Ultimate Fighting Championship has already postponed three events after officials were unable to find venues to stage fights amid restrictions put in place to combat the COVID-19 pandemic. – AFP

    UFC 249 postponed again
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    https://www.thesundaily.my/sport/ufc-249-postponed-again-EF2241152

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  • Medical Product Alert N°4/2020

    Medical Product Alert N°4/2020

    This Medical Product Alert relates to a number of confirmed falsified chloroquine products circulating in the WHO region of Africa. Please note that this Medical Product Alert n°4/2020 will be updated as new reports of falsified chloroquine are received and validated by WHO.

    Between 31 March and 2 April 2020, the WHO global surveillance and monitoring system on substandard and falsified (SF) medical products received nine reports of confirmed falsified chloroquine products from three countries. All reported products were identified at patient level and all have been confirmed as falsified.

    This WHO medical product alert N°4/2020 refers to nine different falsified chloroquine products, with different presentations (see Table 1). It is important to note that widespread vigilance is required from all countries, regardless of where the product was originally identified.

    Table 1: List of identified falsified chloroquine products, subject of WHO Alert N°4/2020
    table1

    All the products listed in Table 1 are confirmed as falsified, on the basis that they deliberately/fraudulently misrepresent their identity, composition or source. Indeed, it can be noted that:

    • either: the products do not contain the correct amount of the active pharmaceutical ingredient, based on the results of preliminary or full compendial analysis;
    • and/or: the products were not produced by the manufacturer whose name is stated on the product labels, and the variable data (batch number and dates) of the above products do not correspond to genuine manufacturing records;
    • and/or: the manufacturer whose name is stated on the product labels does not exist.

    Chloroquine phosphate or sulfate is referenced on the WHO Model List of Essential Medicines for the treatment of Plasmodium vivax infection (malaria). Large clinical trials are under way to generate the robust data needed to establish the efficacy and safety of chloroquine and hydroxychloroquine in the treatment of COVID-19. These medicines are currently authorized for malaria and certain autoimmune diseases and it is important that patients do not face shortages caused by stockpiling or use outside the authorized indications. 
    Both chloroquine and  hydroxychloroquine can have serious side effects, especially at high doses or when combined with other medicines.

    The SOLIDARITY trial, led by WHO, is reviewing potential treatments for COVID-19. Please refer to  WHO medical product alert n°3/2020 for general information on falsified medical products in relation to the management 
    of COVID-19.

    For photographs of products listed in Table 1, please refer to the WHO Medical Product Alert website, and 
    to the annex of this medical product alert n°4/2020 (see pages 3-7).

    WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products.

    If you are in possession of the above products, please do not use. If you have used these falsified products, or if you suffer an adverse reaction/event having used these products, you are advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre.

    All medical products must be obtained from licensed, authentic and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.

    National regulatory/health authorities are advised to immediately notify WHO if these falsified products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact: rapidalert@who.int. 

    WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products
    For more information, please visit: www.who.int/medicines/regulation/ssffc/en/ 

    Annex: Photographs of falsified chloroquine products circulating in the WHO region of Africa, Medical Product Alert N°4/2020

    CAMEROON

    Photographs of confirmed falsified Chloroquine Phosphate (100mg)
    ChloroquinePhosphate250mgCameroon-1

    Photographs of confirmed falsified Chloroquine Phosphate (250mg)
    ChloroquinePhosphate250mgCameroon-2

    Photographs of confirmed falsified Chloroquine Phosphate 250mg
    ChloroquinePhosphate250mg-Cameroon 3

    DEMOCRATIC REPUBLIC OF CONGO

    Photographs of confirmed falsified CLOROQUINE 250MG
    ChloroquinePhosphate250mgDRC1

    Photographs of confirmed falsified Chloroquine Phosphate 250mg
    ChloroquinePhosphate250mgDRC2

    NIGER

    Photographs of confirmed falsified Samquine 100 (100mg)

    Samquine100-100mgNiger 1

    Photographs of confirmed falsified Chloroquine phosphate tablets B.P 100mg

    Chloroquine-phosphate-tabletsB.P100mgNiger2

    Photographs of confirmed falsified Niruquine (100mg)
    Niruquine00mgNiger3

     

    Medical Product Alert N°4/2020
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    https://www.who.int/news-room/detail/09-04-2020-medical-product-alert-n4-2020

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