![]() ![]() Jaundice has been reported eight times by Ofev patients, with two cases resulting in death and four in hospitalization. According to the FDA, two Ofev patients reported hyperbilirubinemia, with one case resulting in death. Jaundice is the yellowish discoloration of the skin that results when there is too much bilirubin in the blood. Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood, which is the substance that is formed when red blood cells break down. In addition to drug-induced liver injury, post-marketing reports link Ofev to hyperbilirubinemia and jaundice. Drug-induced liver injury has been reported to the FDA’s Adverse Event Reporting System (FAERS) 26 times by Ofev patients, with five cases resulting in death, 12 in hospitalization, one in disability, and one was described as life-threatening. In August 2017, the FDA identified cases of drug-induced liver injury with use of Ofev (nintedanib). Ofev and Esbriet were not curing IPF, but studies showed that they slowed the progression of the disease. At the time these drugs were approved, researchers noted that they don’t understand exactly how Ofev and Esbriet work in the body against IPF, but the drugs seem to inhibit important pathways to help prevent scarring. In October 2014, two drugs were approved to treat individuals suffering from idiopathic pulmonary fibrosis – Ofev (nintedanib) and Esbriet (pirfenidone). Doctors can generally determine the cause of fibrosis, but in cases where there is no known cause, they refer to the disease as “idiopathic” pulmonary fibrosis. ![]() When the lung tissue thickens, oxygen is unable to move properly into the bloodstream, often leading to death. The formation of scar tissue is called fibrosis. Pulmonary fibrosis is a disease in which tissue deep in the lungs becomes thick over time. IPF is a rare and fatal lung disease that affects as many as 132,000 patients in the U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) capsules for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. ![]()
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