A Veozah drug label change made on August 31, 2024, added new warnings about liver toxicity and abnormal liver test results, according to a September 12, 2024, Veozah liver problems FDA Drug Safety Communication.
According to the “Additional Information for Patients” section of the September 2024 FDA Veozah liver problems warnings document, signs and symptoms that suggest liver problems include:
- feeling more tired than usual;
- nausea;
- vomiting;
- unusual itching;
- light-colored stools;
- yellowing of the eyes or skin, called jaundice;
- dark urine;
- swelling in the stomach or belly area, called the abdomen; or,
- pain in the right upper abdomen.
The Veozah liver problems warnings FDA Drug Safety Communication instructed patients and doctors to stop Veozah if signs and symptoms of liver injury occur.
As background, Veozah (fezolinetant) was approved by the FDA in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause.
The newly added Veozah liver problems warnings are included in the Veozah Prescribing Information document, or drug label, “Revised: 8/2024” version. In particular, new warnings about liver toxicity and abnormal liver test results were added to this important part of the Veozah drug label: 5 WARNINGS AND PRECAUTIONS, 5.1 Hepatic Transaminase Elevation and Hepatotoxicity.
There may be some women who were using Veozah and then diagnosed with a serious liver injury at some point between May 2023 and August 2024, the period when the additional information found in those new paragraphs was not in the Veozah drug label. For those women, there are possible drug injury lawsuits that would be filed against Astellas Pharma for failure to adequately warn about liver toxicity and abnormal liver tests associated with Veozah use.
We will continue to monitor developments regarding this new Veozah liver problems warning drug safety issue.
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