FDA Issues Warning on Serious Liver Injury Risk With Veozah

Filing Lawsuits for Compensation Due to Liver Injuries Caused by Fezolinetant

The FDA recently issued a significant warning about the potential for serious liver injury related to Veozah (fezolinetant), a medication prescribed to manage moderate to severe hot flashes caused by menopause. This medication, which has been on the market since 2023, was developed as a non-hormonal alternative for women seeking relief from menopausal symptoms. However, recent reports of liver damage in patients using Veozah have raised concerns about its safety. The FDA’s warning follows a post-marketing case in which a woman developed serious liver injury after approximately 40 days of treatment, leading the agency to implement stricter guidelines for monitoring liver function during therapy.

The FDA has updated its prescribing recommendations to include additional liver function tests at more frequent intervals. Healthcare providers are now instructed to perform baseline liver tests before initiating treatment and continue testing monthly for the first three months. Additional tests are recommended at six and nine months. The goal of these frequent tests is to catch signs of liver damage early and prevent further injury by discontinuing the drug if abnormalities are detected.

Veozah works by blocking the neurokinin 3 receptor, which helps regulate body temperature—a key issue for women experiencing hot flashes during menopause. While it provides relief for many women, the risk of liver damage is a serious concern. Symptoms of liver injury include fatigue, nausea, jaundice, dark urine, pale stools, and abdominal pain. If patients experience these symptoms, they are advised to stop taking the medication immediately and consult their healthcare provider.

Despite the rarity of liver injury cases related to Veozah, the potential harm is significant, prompting legal questions about whether the manufacturer, Astellas, provided adequate warnings about these risks. Patients who have suffered liver damage due to this drug may have the right to pursue legal action against the company.

How Veozah Can Harm Patients

Veozah, although effective for treating menopausal hot flashes, can pose a significant risk to liver health. In the reported case, the patient began experiencing symptoms such as fatigue, nausea, itching, and jaundice—classic signs of liver dysfunction—within weeks of starting the medication. These symptoms were confirmed by elevated liver enzyme levels in blood tests, which indicated that the liver was under significant stress. Fortunately, after discontinuing the drug, the patient’s liver function gradually returned to normal.

Liver injury can lead to serious complications, including chronic liver disease, cirrhosis, or even liver failure in extreme cases. Symptoms like jaundice (yellowing of the skin and eyes), dark urine, pale stools, and right upper abdominal pain often indicate liver dysfunction. If liver damage is detected early and the drug is discontinued, some patients may recover without long-term consequences. However, in cases where the injury is more severe or not promptly addressed, the damage can be lasting, leading to permanent health issues and a diminished quality of life.

Patients who suffer from drug-induced liver injury as a result of taking Veozah may be eligible to seek compensation through a product liability lawsuit. These cases hinge on whether the drug manufacturer properly warned consumers about the risks associated with the medication and whether they took all reasonable steps to prevent harm.

Filing a Product Liability Lawsuit for Veozah Injuries

If you or a loved one has been harmed by Veozah, you may be entitled to file a product liability lawsuit against Astellas, the drug’s manufacturer. These lawsuits allow injured patients to seek compensation for the harm caused by dangerous or defective medications. In the case of Veozah, a product liability claim could allege that the manufacturer failed to provide adequate warnings about the risk of liver damage or that the drug itself was defective and unsafe for its intended use.

The process of filing a lawsuit begins with a thorough investigation of your case, including medical records, the timeline of events, and evidence linking your liver injury to the use of Veozah. Your attorney will help gather this information and evaluate whether you have a strong case for seeking compensation. They will also investigate whether the manufacturer knew or should have known about the risks of liver injury and whether their actions contributed to the harm you experienced.

Once the case is filed, both parties will engage in the discovery process, where evidence is exchanged and witnesses are interviewed. Your attorney will also work to negotiate a settlement that fairly compensates you for your losses, which could include medical bills, lost wages, and pain and suffering. If a settlement cannot be reached, the case may go to trial, where a judge or jury will decide the outcome.

Throughout this process, it is critical to have an experienced attorney representing your interests. They will manage the legal complexities of the case, ensuring that all paperwork is filed correctly and on time, and that your rights are protected at every stage. Without legal representation, navigating this process and standing up against a pharmaceutical company can be extremely challenging.

Why You Need an Attorney for a Veozah Lawsuit

Hiring an attorney for a product liability case involving Veozah is essential for several reasons. First, these types of lawsuits are complex, often involving extensive medical evidence, expert testimony, and legal arguments about the manufacturer’s responsibilities. Your attorney will help gather the necessary evidence, including medical records and FDA reports, to build a strong case linking your liver injury to the drug.

Additionally, pharmaceutical companies typically have powerful legal teams defending them, and going up against these companies without experienced representation puts you at a disadvantage. An attorney will handle all communication with the opposing party, negotiate on your behalf, and ensure that your case is as strong as possible. They will also ensure that your lawsuit is filed within the statute of limitations, which sets a time limit on how long you have to bring a claim after your injury occurs.

In a product liability lawsuit involving Veozah, you may be eligible to recover several types of damages. These can include compensation for medical expenses related to your liver injury, lost wages if you were unable to work due to your illness, and damages for pain and suffering. In cases where the drug manufacturer acted with gross negligence or malice, you may also be entitled to punitive damages, which are designed to punish the company and deter similar behavior in the future.