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Drug-induced liver injury (DILI) is a cause of acute and chronic liver disease caused specifically by medications and the most common reason for a drug to be withdrawn from the market after approval. The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents.
Hy's law is a rule of thumb that a patient is at high risk of a fatal drug-induced liver injury if given a medication that causes hepatocellular injury (not Hepatobiliary injury) with jaundice. [1] The law is based on observations by Hy Zimmerman, a major scholar of drug-induced liver injury.
On Friday, Novo Nordisk A/S (NYSE:NVO) released headline results from part 1 of the ongoing ESSENCE Phase 3 trial, a 240-week trial in 1,200 adults with metabolic dysfunction-associated ...
The FDA first warned in September that the drug could cause liver problems. It escalated that warning after reviewing the case of a person with blood markers of liver injury who had been taking ...
FXR-dependent processes in liver and intestine were proposed as therapeutic targets in human diseases. [7] Obeticholic acid is the first FXR agonist to be used in human drug studies. [medical citation needed] The FDA has flagged cases of serious liver injury associated with the use of obeticholic acid. [8]
They also raised concerns about the drug's safety, as 11 patients who received it during the trial died or required a liver transplant, compared with two patients on placebo.
It is suspected that the toxicity of fialuridine was a result of mitochondrial damage caused by the incorporation of fialuridine into mitochondrial DNA via its 3'-hydroxyl moiety, leading to impaired DNA synthesis. This toxicity was unusual in that it was not predicted by animal studies. [1] [2] [3]
(Reuters) -The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences' liver disease treatment, Livdelzi, which it gained through a $4.3 billion buyout of CymaBay Therapeutics ...