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Veozah (Fezolinetant) FDA Action Over Risk of Serious Liver Injury and Your Legal Rights

In May 2023, the U.S. Food and Drug Administration (FDA) approved Veozah (fezolinetant), a non-hormonal prescription medication designed to treat moderate to severe hot flashes due to menopause.

Initially celebrated as a breakthrough in women’s health, recent FDA warnings have highlighted a rare but serious risk of liver injury associated with its use.

If you have taken Veozah and experienced liver problems, you may have legal rights to pursue compensation.

What Is Veozah?

Veozah is the first medication in its class—neurokinin 3 (NK3) receptor antagonists—approved for treating menopausal hot flashes.

It works by blocking specific receptors in the brain that regulate body temperature, thereby reducing the frequency and severity of hot flashes.

Its non-hormonal nature makes it an attractive alternative for women who cannot or prefer not to use hormone replacement therapies.

Understanding the Risk of Liver Injury

In September 2024, the FDA issued a Drug Safety Communication adding a stronger warning about the rare occurrence of serious liver injury based on a post-marketing report.

A patient developed elevated liver enzymes and signs of liver injury after taking Veozah for approximately 40 days. The patient experienced symptoms such as unusual fatigue, nausea and vomiting, unexplained itching, yellowing of the skin and eyes (jaundice), light-colored stools, dark urine, swelling in the abdominal area, and pain in the right upper abdomen. After discontinuing Veozah, the patient’s symptoms gradually resolved, and liver function returned to normal.

FDA’s Updated Recommendations

In response to this incident, the FDA updated its guidelines for both patients and healthcare professionals.

For Patients:

Patients are advised to stop taking Veozah immediately if they experience any signs of liver injury. Symptoms to watch for include excessive tiredness, nausea, vomiting, itching, yellowing of the skin or eyes, dark urine, light-colored stools, abdominal swelling, or pain in the right upper abdomen. It is crucial to contact the healthcare professional who prescribed Veozah as soon as possible.

For Healthcare Professionals:

Healthcare providers should conduct liver function tests before initiating Veozah treatment. They are now recommended to perform monthly liver tests for the first three months after starting the medication, followed by tests at months six and nine. Providers should inform patients about the risk of elevated liver enzymes and serious liver injury, advising them to be vigilant for symptoms and to discontinue use if they occur.

Your Legal Rights and Potential Claims

If you have suffered liver injury after taking Veozah, you may have grounds for a legal claim against the manufacturer, Astellas Pharma. Legal actions can hold the company accountable and provide compensation for your losses.

Potential legal claims could involve failure to warn—alleging inadequate warnings about the risks of serious liver injury; product liability—claiming that Veozah is defective due to its potential to cause harm; and negligence—suggesting insufficient testing and monitoring of the drug’s safety profile.

Potential Compensation

A successful legal claim could result in compensation covering medical expenses for hospital stays, treatments, medications, and future medical care. You may also recover lost wages due to inability to work, compensation for pain and suffering addressing physical discomfort and emotional distress, and loss of quality of life if long-term effects impact your daily living.

Next Steps: Protect Your Health and Legal Interests

The full scope of Veozah’s risks is still being explored. If you have taken Veozah, it’s crucial to take proactive steps. Seek medical attention immediately if you notice any symptoms of liver injury. Keep detailed records of your symptoms, medical visits, treatments, and any communications regarding your condition. Consult a legal professional experienced in dangerous drug cases to receive guidance tailored to your situation.

We Are Here to Help

Our firm is actively investigating claims related to Veozah and its potential side effects. We are committed to advocating for individuals affected by this medication.

Contact us today for a free, no-obligation consultation to discuss your case and explore your legal options. Time limits may apply for filing a claim, so it is important to act promptly.

Disclaimer: This article is for informational purposes only and does not constitute medical or legal advice. Consult a healthcare professional for medical concerns and a qualified attorney for legal advice pertaining to your specific circumstances.

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