Veozah Lawsuit – How to Bring a Claim

FDA has warned that Veozah (fezolinetant), a menopause hot flash medicine, can cause rare but serious liver injury. People with liver problems after taking it may ask about a product-liability claim against Astellas Pharma. On December 16, 2024, FDA added a Boxed Warning, its most prominent warning, to the drug’s label. No MDL, class action, settlement or verdict has been reported for Veozah. Individual claims remain possible. FDA tells patients with signs of liver injury to stop taking Veozah immediately and contact a health care professional.

Latest Veozah Lawsuit Updates

December 16, 2024: FDA Adds Boxed Warning for Liver Injury

FDA added a Boxed Warning for the known risk of rare but serious liver injury to its Drug Safety Communication on Veozah [1].

September 12, 2024: FDA Issues Drug Safety Communication

FDA first issued the communication on liver injury linked to Veozah. It added a warning and more frequent liver blood testing to the prescribing information, then updated the same communication on December 16, 2024.

May 12, 2023: FDA Approves Veozah

FDA approved Veozah (fezolinetant) for moderate to severe hot flashes caused by menopause. It was the first NK3 receptor antagonist approved for this use [2]. Approval went to Astellas Pharma US, Inc. The approved dose is one 45 milligram pill taken by mouth once a day. The liver injury warnings came later, in 2024.

What Is Veozah?

According to Harvard Health, fezolinetant (Veozah) is a nonhormonal drug. It affects how the brain controls body temperature. FDA approved it in May 2023 to reduce how often hot flashes happen and how severe they are [3]. FDA describes it as a neurokinin 3 (NK3) receptor antagonist. It is a tablet that patients take by mouth once daily.

Who May Be Affected?

People prescribed Veozah for menopausal hot flashes who later developed signs of liver injury may be affected. FDA lists these signs of liver injury:

• Feeling more tired than usual, nausea or vomiting
• Unusual itching or light-colored stools
• Yellowing of the eyes or skin (jaundice) or dark urine
• Swelling in the abdomen or pain in the right upper abdomen

Whether a claim exists depends on facts such as when you started Veozah, when symptoms began and what your liver tests showed. That takes an individual legal review of your medical records.

Reported Injuries or Damages

The injury at issue is liver injury. The FDA notice describes one case of serious drug-induced liver injury reported to FAERS. It is a regulator report, separate from any complaint. Within 40 days of starting Veozah, the patient’s alanine transaminase rose more than 10 times the normal level. Alkaline phosphatase rose more than four times. Total bilirubin rose more than 3 times. Symptoms slowly went away after the medicine was stopped, and blood values returned to normal. FDA concluded this patient had liver injury as a result of Veozah treatment.

Recall and Regulatory Background

Veozah has not been recalled and FDA has not announced a withdrawal. The FDA action is a safety labeling change, and Veozah stays on the market. The prescribing information tells doctors not to start Veozah if liver test results are high. That means ALT, AST or total bilirubin at two or more times the upper limit of normal.

Evidence to Preserve

Keep records that show what you took, when you started and what happened to your liver. Useful items include:

• Prescription and pharmacy records showing the Veozah dose and start date
• The bottle and the patient information leaflet that came with it
• Liver blood test results from before and during your treatment
• Medical records and diagnoses of liver injury
• A dated symptom diary and photographs of jaundice
• Communications with your prescriber and with Astellas Pharma
• A copy of any side effect report you filed with FDA
• Receipts for related medical costs

Filing Deadlines

State law sets the time limit for a claim, so the limit for you depends on your state. It also depends on when your liver injury and its diagnosis happened. Some states count from the day of diagnosis instead of the day of the injury. A claim filed after the limit can be barred, even with good records. A lawyer can tell you which limit applies to your situation. Talk to one promptly, because the clock may already be running.

Frequently Asked Questions

How Often Are Liver Tests Needed on Veozah?

Liver tests on Veozah are needed before starting, then every month for the first 3 months, and again at months 6 and 9. FDA lists this schedule for health care professionals.

How Common Is Veozah Liver Injury?

FDA cannot say how common Veozah liver injury is. The agency says it cannot determine how likely it is that someone will have these side effects. It calls the injury rare but serious.

What Does the Research Say About Veozah and Liver Injury?

The research FDA cites on Veozah and liver injury says stopping the medicine could prevent worse liver injury and potentially return liver function to normal. FDA is warning that Veozah can cause rare but serious liver injury.

How Many Patients Were Dispensed Veozah?

An estimated 28,700 patients were dispensed Veozah in May 2024 from U.S. outpatient retail pharmacies. That figure comes from IQVIA data cited in the FDA Drug Safety Communication.

What Should I Do If I Think Veozah Harmed My Liver?

If you think Veozah harmed your liver, report the side effect to FDA at 1-800-332-1088 or online. Keep your medical records and test results together, and bring them to any appointment with your health care professional.

References

1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due
2. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause
3. https://www.health.harvard.edu/womens-health/fda-approves-first-drug-designed-to-treat-hot-flashes