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WHO: Medical Product Alert N°1/2024: Falsified (contaminated) USP/EP PROPYLENE GLYCOL

This WHO Alert refers to falsified DOW USP/EP PROPYLENE GLYCOL detected in Pakistan. Authentic DOW USP/EP PROPYLENE GLYCOL is a raw material (excipient) utilized in pharmaceutical and other manufacturing processes, adhering to the standards of the United States and European Pharmacopoeias (USP/EP) for medicinal use. WHO has previously published seven Alerts on contaminated oral liquid medicines.  Following WHO Medical Product Alert N°8/2023 Product Alert N°8/2023 in December 2023, the Drug Regulatory Authority of Pakistan (DRAP) investigated potential contamination of oral liquid medicines. Suspect drums of PROPYLENE GLYCOL were identified by DRAP, and samples were tested by Pakistan’s Central Drugs Laboratory. The analyses revealed unacceptable levels of ethylene glycol contamination, ranging from 0.76% to 100%. Between January and March 2024, DRAP issued three Rapid Alerts regarding five contaminated batches of DOW USP/EP PROPYLENE GLYCOL. DOW has confirmed that the raw materials detailed in the DRAP Alerts, and identified in this WHO Alert are falsified and were not manufactured or supplied by DOW. The quality and safety of these excipients therefore cannot be assured. The PROPYLENE GLYCOL materials identified in this Alert are considered to have been deliberately and fraudulently mislabelled. They contain high levels of ethylene glycol, which if ingested can be toxic. These raw materials may have been distributed to other countries, including through informal or unregulated markets. Manufacturers of oral liquid medicines may have unknowingly purchased these contaminated raw materials, which may still be in their storage facilities.

  • 19 April, 08:50
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WHO sounds alarm on viral hepatitis infections claiming 3500 lives each day

According to the World Health Organization (WHO) 2024 Global Hepatitis Report, the number of lives lost due to viral hepatitis is increasing. The disease is the second leading infectious cause of death globally -- with 1.3 million deaths per year, the same as tuberculosis, a top infectious killer. The report, released at the World Hepatitis Summit, highlights that despite better tools for diagnosis and treatment, and decreasing product prices, testing and treatment coverage rates have stalled. But, reaching the WHO elimination goal by 2030 should still be achievable, if swift actions are taken now. New data from 187 countries show that the estimated number of deaths from viral hepatitis increased from 1.1 million in 2019 to 1.3 million in 2022. Of these, 83% were caused by hepatitis B, and 17% by hepatitis C. Every day, there are 3500 people dying globally due to hepatitis B and C infections. Updated WHO estimates indicate that 254 million people live with hepatitis B and 50 million with hepatitis C in 2022. Half the burden of chronic hepatitis B and C infections is among people 30–54 years old, with 12% among children under 18 years of age. Men account for 58% of all cases. New incidence estimates indicate a slight decrease compared to 2019, but the overall incidence of viral hepatitis remains high. In 2022, there were 2.2 million new infections, down from 2.5 million in 2019. These include 1.2 million new hepatitis B infections and nearly 1 million new hepatitis C infections. More than 6000 people are getting newly infected with viral hepatitis each day. The report outlines a series of actions to advance a public health approach to viral hepatitis, designed to accelerate progress towards ending the epidemic by 2030. They include: expanding access to testing and diagnostics; shifting from policies to implementation for equitable treatment; strengthening primary care prevention efforts; simplifying service delivery, optimizing product regulation and supply; developing investment cases in priority countries; mobilizing innovative financing; using improved data for action; and engaging affected communities and civil society and advancing research for improved diagnostics and potential cures for hepatitis B.

  • 18 April, 14:43
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