Veozah (fezolinetant), a non-hormonal drug hailed as a breakthrough for managing menopausal hot flashes, was approved by the FDA in May 2023. Marketed as a safe alternative to hormone replacement therapies, Veozah quickly gained popularity among women seeking relief from debilitating vasomotor symptoms. However, the celebration was short-lived. Reports of severe liver injuries linked to the drug began to surface, prompting FDA interventions and spurring a wave of lawsuits.
Patients allege that Veozah’s manufacturer, Astellas Pharma, failed to adequately warn consumers and healthcare providers about the significant risks associated with its use. As the number of affected individuals grows, legal action is shedding light on the dangers of insufficient drug testing and corporate negligence.
Reverse Chronological Timeline of Key Events
December 16, 2024
The FDA updates Veozah’s prescribing information, adding a prominent Boxed Warning about the risk of severe liver injury. This update reflects growing concerns about Veozah’s hepatotoxicity.
December 1, 2024
New medical studies suggest that in additional to causing liver damage, women who use Veozah may be at increased risk of developing certain types of cancer. The study reported that women using Veozah were 4.3 times more likely to be diagnosed with cancer.
November 26, 2024
A recent article highlights potential concerns about fezolinetant, a non-hormonal therapy designed to treat vasomotor symptoms (VMS) during menopause. While the drug has shown promise as an NK-3 receptor antagonist in alleviating hot flashes, the authors underscore a significant omission in current discussions: the increased risk of neoplasms (tumors) associated with its use.
Their analysis, published in The Lancet, revealed a statistically significant rise in neoplasm cases, particularly among patients taking a 45 mg dose of fezolinetant. The meta-analysis reported a Peto odds ratio of 4.25, indicating a potential dose-dependent relationship. Despite these findings, regulatory agencies like the FDA and EMA have not included this risk in the drug’s prescribing information, citing a lack of causal evidence.
The authors, however, challenge this assessment, pointing out the distinct pharmacological mechanisms of NK-3 receptor antagonists compared to NK-1 antagonists, which have been referenced in dismissing the cancer risk.
The authors argue for greater caution, recommending additional long-term safety studies and vigilant post-marketing surveillance. They emphasize the importance of including these risks in safety discussions to enable informed decision-making for postmenopausal women and healthcare providers. While fezolinetant offers significant benefits in managing menopause symptoms, these findings highlight the critical need for balancing efficacy with potential long-term safety concerns.
September 12, 2024
The FDA issues a Drug Safety Communication, advising healthcare professionals and patients to monitor liver function more frequently during Veozah use. The announcement follows a post-marketing report of severe liver injury within 40 days of treatment.
July 2024
Astellas Pharma publishes new marketing materials emphasizing Veozah’s effectiveness while downplaying safety risks, sparking criticism from consumer advocacy groups.
May 2023
Veozah receives FDA approval, becoming the first non-hormonal treatment for menopausal hot flashes. Early reviews highlight its innovation but raise questions about long-term safety.
2022:
Phase 3 clinical trials (SKYLIGHT 1 and SKYLIGHT 2) conclude, with data showing significant reductions in hot flashes. However, trial results note elevated liver enzyme levels in some participants.
About Veozah
Veozah is a prescription medication just recently approved by the FDA to treat moderate to severe vasomotor symptoms, commonly known as hot flashes, associated with menopause. These symptoms, which result from hormonal fluctuations, affect millions of women, significantly impacting their quality of life. Veozah is part of a new class of non-hormonal therapies, offering an alternative to traditional hormone replacement treatments.
Veozah works by targeting and inhibiting the neurokinin-3 (NK3) receptor, which plays a role in regulating body temperature. Unlike hormone-based treatments, Veozah focuses directly on the central mechanism behind hot flashes without altering hormone levels. This make it a very attractive option for women seeking relief from menopause symptoms without using estrogen or progesterone.
While Veozah has been heralded as a breakthrough in menopausal symptom management, like all medications, it carries potential risks. Everyone understands there are risk with drugs. Patients just want to know what they are. Clinical trials and post-market surveillance have raised concerns about liver-related complications. Reports of liver injury have led healthcare providers to recommend regular liver function monitoring for patients using Veozah. Some doctors have taken patients off the drug.
For individuals who have experienced significant liver damage or related health issues after taking Veozah, there may be legal recourse to explore compensation for medical expenses, pain, and suffering.
Side Effects of Veozah
We can all agree that Veozah has provided real relief for many menopausal women. But its side effects have proven severe in some cases, leading to significant medical complications.
Common Side Effects:
- Nausea
- Diarrhea
- Insomnia
- Back pain
- Mild hot flashes during the adjustment period
Severe Side Effects:
- Liver Damage: Symptoms include jaundice, dark urine, light-colored stools, fatigue, nausea, vomiting, and abdominal pain. Liver function tests often reveal elevated enzyme levels.
- Allergic Reactions: Breathing difficulties, facial swelling, hives, and joint pain may require immediate medical attention.
The risk of liver injury is, of course, the what this page is all about. Patients have reported severe complications within weeks of starting the medication, sometimes requiring hospitalization.
FDA Changes to Veozah Warning Label
The FDA has issued multiple updates to Veozah’s prescribing information and black-box warning label, highlighting the risks of severe liver disease associated with the menopause drug. These updates caution users about the potential for drug-induced liver toxicity. Most recently, on December 16, 2024, the FDA revised Veozah’s black-box warning to emphasize the risks of hepatic toxicity, elevated liver enzymes, and early warning signs of liver damage.
What Went Wrong?
The lawsuits against Veozah’s manufacturer center on claims of corporate negligence and inadequate warnings.
- Insufficient Pre-Market Testing: Astellas Pharma’s clinical trials noted liver enzyme elevations in some participants, yet the company failed to adequately investigate these findings before bringing the drug to market.
- Delayed FDA Action: Despite early post-marketing reports of liver injury, the FDA did not issue a formal warning until September 2024, over a year after Veozah’s approval. What did they know before it was on the market and when did the evidence reach a critical mass where they made the change? These will be key questions.
- Marketing Missteps: Veozah was heavily promoted as a safe and innovative alternative to hormone replacement therapy. Critics argue this messaging obscured the drug’s risks, leaving patients uninformed about potential dangers.
- Failure to Update Prescribing Guidance: Initial recommendations for liver function monitoring were minimal. Only after significant public pressure did the FDA require monthly liver function tests for the first two months of treatment.
These failures form the foundation of lawsuits that will be filed by patients who suffered severe side effects.
Who Is Eligible to File a Veozah Lawsuit
To qualify for a potential Veozah liver damage lawsuit, prospective plaintiffs must meet certain eligibility requirements. Our firm’s current eligibility criteria for Veozah liver cases are as follows:
Use of Veozah: Eligible plaintiffs must show that they were prescribed Veozah for hot flashes and they actually took the drug for a least 6 months. Plaintiff should be able to prove this with medical records or pharmacy records.
Liver Injury: Potential plaintiffs will also need to show that at some point AFTER taking Veozah, they were medically diagnosed with liver damage, or liver-related conditions that have been linked to Veozah such as fatty liver disease, jaundice, hepatitis, or elevated liver enzymes.
Settlement Value of Veozah Lawsuits
It is still very early in the litigation to say with any real accuracy what the potential settlement value of Veozah cases might be. However, we can offer some estimates of what the potential settlement payout of these cases could be based on settlements in prior cases involving similar defective drugs.
Our lawyers think that successful Veozah liver damage cases in the top settlement tier (i.e., those involving the most serious injuries) could have a settlement value of $250,000 to $600,000. Veozah cases in the second settlement tier could have an settlement value of $100,000 to $225,000. There may also be cases involving minimal liver damage that end up in a third settlement tier with payouts of $50,000 or less.
Q&A About Veozah Litigation
Q: What is Veozah, and how does it work?
A: Veozah is a non-hormonal medication designed to treat menopausal hot flashes. It works by targeting neurokinin 3 receptors in the brain, which helps regulate body temperature.
Q: What are the risks of taking Veozah?
A: The most significant risk is severe liver injury, which can occur within weeks of starting treatment. Symptoms include jaundice, dark urine, and abdominal pain.
Q: Who can file a lawsuit against Veozah’s manufacturer?
A: Individuals who experienced severe side effects, particularly liver damage, after using Veozah may be eligible to file a claim. Families of deceased patients may also pursue wrongful death claims.
Q: What compensation can I seek?
A: Potential damages include reimbursement for medical expenses, lost income, emotional distress, and punitive damages.
Q: How long do I have to file a lawsuit?
A: The statute of limitations varies by state, typically ranging from 1 to 6 years from the date of injury or diagnosis.
Q: How can I strengthen my claim?
A: Collect medical records, prescription details, and evidence of liver function tests. Consult an experienced attorney to evaluate your case.
Q: What proof do I need to file a claim?
A: Potential plaintiffs will only need proof of 2 simple things: (1) that they used Veozah, and (2) that they were diagnosed with liver damage. Both of these can be proven with medical records.
Q: Is there a Veozah class action?
A: No. At this time there is no Veozah liver damage class action. A large number of these cases are expected to get filed, but they will probably be consolidated into a MDL (multi-district litigation) which is similar to a class action but not the same.
Contact Us About Veozah Liver Damage Lawsuits
If you took Veozah and subsequently suffered liver damage or health complications involving your liver, contact our national product liability lawyers at 800-553-8082 or contact us online.