August 2024 Veozah Drug Label Change Adds Warnings About Liver Toxicity and Abnormal Liver Tests
(Posted by Tom Lamb at Drug Injury Watch)
On September 12, 2024, the FDA announced a warning about the rare occurrence of serious liver injury when a woman is using Veozah for hot flashes due to menopause. This Veozah liver injury FDA Drug Safety Communication instructed patients and doctors to stop Veozah if signs and symptoms of liver injury occur.
In more detail, from the "Additional Information for Patients" section of that September 2024 FDA Veozah liver injury document:
Stop taking Veozah immediately and contact your health professional who prescribed the medicine if you experience signs and symptoms that suggest liver problems. These may 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. Stopping the medicine if there are signs and symptoms that suggest liver injury could prevent worsening liver injury and potentially return liver function to normal.
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, or more exactly "for the treatment of moderate to severe vasomotor symptoms due to menopause".
That more precise information and the newly added Veozah liver injury warnings are included in the Veozah Prescribing Information document, or drug label, "Revised: 8/2024" version.
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Veozah
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In particular, through an FDA Supplemental Approval letter sent to Astellas Pharma US, Inc., which is dated 8/31/2024, several new paragraphs 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 to 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 injury drug safety issue.
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