7 results

• Andexxa Recall Announced After FDA Says Risk of Blood Clots and Death Outweigh Benefits

  December 22, 2025

  Irvin Jackson

  AstraZeneca is removing its blood thinner reversal agent Andexxa from the market after the FDA determined the drug's blood clot risks outweigh its benefits.

• Andexxa Blood Clot Risks Lead to FDA Questions Regarding Safety of the Reversal Agent for Xarelto, Eliquis

  November 21, 2024

  Irvin Jackson

  Safety concerns linked to Andexxa, the reversal agent for newer blood thinners like Xarelto and Eliquis, will be discussed at an FDA advisory panel meeting today, after postmarketing studies indicated the drug doubled the risks of blood clots and death.

• Eliquis Lowers Stroke Risk, But Side Effects Linked to Higher Risk of Major Bleeding: Study

  January 17, 2024

  Katherine McDaniel

  A new study reveals Eliquis decreases the risk of stroke in patients with subclinical atrial fibrillation, but at the cost of an increased risk of major bleeding events.

• Antidote For Xarelto, Eliquis Bleeding Events Approved For Large-Scale Production

  January 8, 2019

  Irvin Jackson

  The FDA has approved Andexxa, a reversal agent for Xarelto and Eliquis, for large-scale production in the face of growing bleeding injury reports.

• Xarelto Antidote Andexxa To Only Get Limited Release To 40-50 Hospitals, Investors Told

  May 10, 2018

  Irvin Jackson

  The release of the highly anticipated Xarelto reversal agent, AndexXa, will be limited to only 40 to 50 hospitals until at least next year, due to concerns the FDA has over the manufacturing process, Portolo Pharmaceuticals CEO told investors.

• FDA Approves AndexXa as Reversal Agent For Xarelto, Eliquis

  May 7, 2018

  Irvin Jackson

  A new reversal agent has been approved for Xarelto and Eliquis but will only continue to be approved if postmarketing studies find no problems.

• Xarelto Reversal Agent Delayed Again, More Clinical Trials May Be Needed

  March 7, 2018

  Irvin Jackson

  The FDA is calling for clinical trials before it will approve the long-delayed Xarelto and Eliquis reversal agent, AndexXa.