86 results

• Tavneos Recall Pressure Mounts, As EU Joins FDA Seeking Market Removal

  July 1, 2026

  Irvin Jackson

  The EU weighs a Tavneos recall following the release of data suggesting the autoimmune treatment's clinical trial results were manipulated to make Tavneos look safer and more effective than it actually is.

• Alli Side Effects Include Risk of Kidney Stones, Renal Injury: FDA Warns

  June 12, 2026

  Irvin Jackson

  The FDA has added new kidney stone and acute kidney injury warnings to the label of Alli, an over-the-counter weight loss drug.

• Tavneos Liver Injury Risks, Faked Data Lead FDA To Seek Market Removal

  April 29, 2026

  Irvin Jackson

  Amgen has received a letter from the FDA indicating the agency plans to remove Tavneos from the market after discovering falsified data in the original clinical trial.

• Tavneos Side Effects Linked to Severe Liver Injuries, FDA Warns

  April 1, 2026

  Michael Adams

  Federal regulators warn Tavneos may cause serious and potentially fatal liver injuries, with postmarketing data identifying 76 adverse cases, including 54 hospitalizations and eight deaths.

• Ocaliva Lawsuits Over Failure To Warn About Liver Injury Problems May Follow Market Withdrawal

  November 7, 2025

  Irvin Jackson

  Ocaliva, promoted as a treatment to prevent liver injury, has been recalled following reports of high rates of liver damage and patient deaths.

• Ocaliva Market Withdrawal To Take Final Effect on Nov. 14

  October 21, 2025

  Irvin Jackson

  The recalled liver disease drug Ocaliva will no longer be available to patients after November 14, following its rejection by the FDA over liver injury risks.

• Ocaliva Liver Side Effects Are Higher for Patients Who Didn’t Respond to Drug: Study

  October 14, 2025

  Irvin Jackson

  Patients who were unresponsive to Ocaliva treatment faced significantly increased risks of liver injury and cirrhosis, according to a study published just days after the drug's recall.

• Ocaliva Recall Issued Due to Liver Injury Risks

  September 12, 2025

  Irvin Jackson

  Intercept has announced it is removing the liver disease drug Ocaliva from the market after the FDA determined it does more harm than good.

• FDA Adds Veozah Liver Injury Warnings in “Black Box” on Menopause Drug’s Label

  December 18, 2024

  Irvin Jackson

  Side effects of Veozah have been linked to reports of rare, but serious liver injuries, leading to new warnings that urge users to stop taking the menopause drug if they experience symptoms of liver problems, like jaundice.

• FDA Warns of Ocaliva Liver Injury Risks Linked to Autoimmune Disorder Drug

  December 13, 2024

  Martha Garcia

  Federal regulators warns that the autoimmune treatment Ocaliva has been linked to liver damage and failure, resulting in patient deaths and the need for transplants.