FDA flags serious liver injury cases, 8 deaths with ‘reasonable’ link to Amgen's Tavneos

Summary: The FDA is warning that Amgen's rare disease drug, Tavneos, can cause severe liver damage. The drug is linked to 76 cases of liver injury and 8 deaths. It can also cause a rare condition where the body's bile ducts vanish. Because of these dangers, the FDA asked Amgen to take Tavneos off the market. However, Amgen said no, claiming the drug is still safe and helpful. Amgen bought the drug's original maker for $3.7 billion in 2022 and inherited these issues. Doctors are now told to test their patients' livers often.

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Tags

Chemical and Drug Induced Liver Injury
Rare Diseases
Vasculitis
Wounds and Injuries
Death
Disease
Syndrome
Antibodies, Antineutrophil Cytoplasmic
Jaundice