DEFITELIO (Defibrotide Sodium) is the Subject of WHO Alert for Falsified Medical Products No. 3/2023

The DEFITELIO (defibrotide sodium) batch that was found to be false in the United Arab Emirates and publicly disclosed by the national regulatory authorities (in November 2022) is the subject of this WHO Medical Product Alert. Additionally, the fake batch was found in Kyrgyzstan (in March 2023). The forged goods have been located in both US and UK/Ireland packaging.

Defibrotide is an antithrombotic medication used in the treatment of severe veno-occlusive disease (VOD) in adult and pediatric recipients of haematopoietic (blood stem cell) transplants. VOD is a disorder when the liver’s veins obstruct and prevent it from functioning normally. The items mentioned in this Alert are fake, according to the real DEFITELIO producer.

An examination of a sample of the fake product in a lab revealed that none of the claimed active ingredients were present. Additionally, the authentic manufacturer has claimed that the stated batch number 19G19A is a fake DEFITELIO batch number.
The expiration dates are fake. The vial inside the counterfeit US pack, batch 19G19A/Exp 01/2025, has a different batch number: M06B466E, which is not a legitimate batch number. For more information on the items that are affected, please see the Alert’s Annex.

Risks to use of Falsified DEFITELIO

Due to its intravenous delivery and potential for major health concerns, the use of counterfeit DEFITELIO will lead to inadequate patient care. In rare cases, it may even be fatal. WHO is not yet aware of any reports of adverse events occurring after using the counterfeit DEFITELIO, however it is unknown whether the counterfeit items mentioned in this alert are safe, sterile, or of high quality.

Advice for the public and regulatory bodies.

WHO advises against using any impacted products if you own any of them. It is urged that you get immediate medical assistance from a healthcare provider if you or someone you know has used the impacted product or may have done so, or if they experienced an unanticipated side effect or unpleasant reaction. To the National Regulatory Authorities/National Pharmacovigilance Center, healthcare providers should report the incidence. If national regulatory or health authorities discover these phony goods, they are recommended to alert WHO right once.

More About DEFITELIO

DEFITELIO (defibrotide sodium) is a medication that is used to treat a rare and potentially life-threatening condition called hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS). VOD/SOS can occur as a complication of certain types of cancer treatments, such as chemotherapy and stem cell transplants. DEFITELIO works by helping to reduce the inflammation and blood clotting that can occur in the liver as a result of VOD/SOS. It is administered as an injection into a vein by a healthcare professional.

DEFITELIO was approved by the U.S. Food and Drug Administration (FDA) in 2016 for the treatment of VOD/SOS in adults and children with liver or kidney dysfunction following hematopoietic stem cell transplantation (HSCT). As with any medication, DEFITELIO can cause side effects. The most common side effects reported in clinical trials include low blood pressure, diarrhea, vomiting, and nosebleeds. More serious side effects can occur, so it is important to talk to your healthcare provider about any potential risks and benefits of taking DEFITELIO.

About Severe veno-occlusive Disease (VOD)

Severe Veno-occlusive Disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a rare and potentially life-threatening condition that can occur as a complication of certain medical treatments, such as chemotherapy or radiation therapy, or after a bone marrow or stem cell transplant. In VOD/SOS, the small blood vessels in the liver become inflamed and blocked, leading to the accumulation of fluid and clotting in the liver. This can cause damage to the liver and lead to liver failure, which can be fatal.

Symptoms of VOD/SOS can include abdominal pain, swelling, and tenderness, jaundice (yellowing of the skin and eyes), weight gain, and fluid retention. Treatment for VOD/SOS typically involves supportive care, such as managing fluid and electrolyte levels and providing nutritional support. In severe cases, medications such as DEFITELIO may be used to help reduce inflammation and blood clotting in the liver.

Prevention strategies for VOD/SOS include carefully selecting patients who are at high risk for the condition, monitoring patients closely for symptoms, and using medications such as DEFITELIO prophylactically in high-risk patients undergoing stem cell transplantation.

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