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FDA Medwatch Alert: Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury
Posted 22 Sep 2017 by Drugs.com
ISSUE: FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them. Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label. FDA is working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns. BACKGROUND: Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC). PBC causes the bile ducts in the liver to become inflamed, damaged and ... Read more
Posted 15 Jun 2016 by Drugs.com
TUESDAY, May 31, 2016 – Ocaliva (obeticholic acid) has been approved by the U.S. Food and Drug Administration to treat a rare chronic liver disease called primary biliary cholangitis (PBC). The disease causes the liver's small bile ducts to become inflamed, ultimately destroying the ducts and leading to cirrhosis, which is scarring of the liver. Over time, this leads to a potentially deadly loss of liver function, the agency said Tuesday in a news release. Ocaliva is designed to increase bile flow from the liver. The drug was evaluated in clinical studies involving 216 people, and the most commonly recorded side effects included itchy skin, fatigue, abdominal pain, throat pain, dizziness and constipation. Ocaliva should not be given to people whose bile ducts are completely blocked, the FDA warned. Clinical studies have not established an improvement in survival, progression to liver ... Read more
Posted 8 Jun 2016 by Drugs.com
NEW YORK, May 27, 2016 (GLOBE NEWSWIRE) – Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic acid(UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Ocaliva is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. "Intercept was founded on the belief that targeting FXR would benefit patients with liver ... Read more