FDA SIDE EFFECTS UPDATE: New Liver Injury Warnings for MS Drugs and Epilepsy Treatment

Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning these drugs used to treat Multiple Sclerosis (MS): Ocrevus, Ocrevus Zunovo, Briumvi, and Kesimpta. We also are featuring a safety update for epilepsy treatment Xcopri.

Side Effect Update for Multiple Sclerosis Drugs

Multiple Sclerosis (MS) is a chronic and often debilitating disease in which the immune system attacks myelin, the protective coating of nerve cells. This damage interferes with the communication between the brain and body, leading to the symptoms of MS, which may include visual disturbances, muscle weakness, and difficulties with coordination and balance. The MS medicines in this update are newer types of treatments called “anti-CD20 monoclonal antibodies.” They work by targeting and depleting “B” cells, which are cells that contribute to nerve damage.

Briumvi (ublituximab-xiiy) injection for intravenous infusion

Initial FDA Approval: 2022

Side Effect Update Date: August 18, 2025

Medication Description: Treats relapsing forms of multiple sclerosis. Briumvi is administered intravenously by a healthcare professional every 24 weeks after the first two doses.

Updated Side Effect/Safety Information: There’s a new warning about the risk of serious drug-induced liver injury. Before starting Briumvi, patients must undergo liver function assessments, including tests for liver enzymes and bilirubin levels, as well as a screening for Hepatitis B infection. Patients must be monitored for signs of liver injury during treatment. Symptoms that may indicate liver injury include new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or yellowing of the skin or eyes (jaundice). Signs of liver injury have occurred weeks to months after taking the drug.

FDA Safety Announcement: Briumvi FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more. 

Kesimpta (ofatumumab) injection for subcutaneous use

Initial FDA Approval: 2009; approved for MS in 2020

Side Effect Update Date: August 18, 2025

Medication Description: Treats relapsing forms of multiple sclerosis. Kesimpta is self-administered subcutaneously once weekly for the first three weeks, then every four weeks thereafter.

Updated Side Effect/Safety Information: There’s a new warning about the risk of serious drug-induced liver injury. Before starting Kesimpta, patients must undergo liver function assessments, including tests for liver enzymes and bilirubin levels, as well as a screening for Hepatitis B infection. Patients must be monitored for signs of liver injury during treatment. Symptoms that may indicate liver injury include new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or yellowing of the skin or eyes (jaundice). Signs of liver injury have occurred weeks to months after taking the drug.

Essential Extras: Some studies have shown that the risk of liver injury is lower with ofatumumab than with ocrelizumab. Ofatumumab was approved in 2009 as Arzerra, an intravenous infusion treatment for leukemia. In 2020, Novartis received approval for Kesimpta, a subcutaneous formulation of ofatumumab, for treating relapsing forms of multiple sclerosis.

FDA Safety Announcement: Kesimpta FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Ocrevus (ocrelizumab and hyaluronidase-ocsq) intravenous infusion

Initial FDA Approval: 2017

Side Effect Update Date: August 18, 2025

Medication Description: Treats relapsing forms of multiple sclerosis. After the first two doses are administered two weeks apart, Ocrevus is administered intravenously by a healthcare professional twice a year.

Updated Side Effect/Safety Information: There is a new warning about the risk of serious drug-induced liver injury. Before starting Ocrevus, patients must undergo liver function assessments, including tests for liver enzymes and bilirubin levels, as well as a screening for Hepatitis B infection. Patients must be monitored for signs of liver injury during treatment. Symptoms that may indicate liver injury include new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or yellowing of the skin or eyes (jaundice). Signs of liver injury have occurred weeks to months after taking the drug.

FDA Safety Announcement: Ocrevus FDA Safety Label Change  and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection for subcutaneous use

Initial FDA Approval: 2017

Side Effect Update Date: August 18, 2025

Medication Description: Treats relapsing forms of multiple sclerosis. Ocrevus Zunovo is administered subcutaneously in the abdomen by a health care professional twice a year.

Updated Side Effect/Safety Information: There is a new warning about the risk of serious drug-induced liver injury. Before starting Ocrevus Zunovo, patients must undergo liver function assessments, including tests for liver enzymes and bilirubin levels, as well as a screening for Hepatitis B infection. Patients must be monitored for signs of liver injury during treatment. Symptoms that may indicate liver injury include new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or yellowing of the skin or eyes (jaundice). Signs of liver injury have occurred weeks to months after taking the drug.

FDA Safety Announcement: Ocrevus Zunovo FDA Safety Label Change  and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Side Effect Update for Epilepsy Medications

Xcopri (cenobamate) tablets

Initial FDA Approval: 2020

Side Effect Update Date: August 18, 2025

Medication Description: Treats partial-onset seizures in adults

Updated Side Effect/Safety Information: A new warning has been issued regarding the risk of significant liver injury. Before starting Xcopri, patients must undergo a baseline liver function screening to assess liver enzyme and bilirubin levels. There’s also an added warning in the Patient Medication Guide about the risk of problems with the heart’s electrical system (QT shortening). Symptoms of QT shortening include a fast heartbeat (heart palpitations) or fainting.

Essential Extras: Xcopri is classified as a Schedule V controlled drug because of its potential risk for abuse or dependence.

FDA Safety Announcement: Xcopri FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.