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. As of May 2024, approximately 28,700 patients in the U.S. have been prescribed this medication.
The FDA strengthened its safety warnings in September 2024 regarding a rare but serious risk of liver injury associated with the drug’s use. The agency updated the drug’s prescribing information to include specific warnings about liver injury risk, adding to existing warnings about elevated liver enzyme levels.
Given these serious safety concerns and the FDA’s strengthened warnings, patients who have experienced liver complications while taking Veozah should seek immediate medical attention and consider consulting with legal professionals who can evaluate their situation. Time limitations may apply to protecting your legal rights.
Patients who have experienced liver problems while taking Veozah should consult with healthcare providers and consider seeking legal counsel to understand their options.
How Veozah Works
Veozah is a neurokinin 3 (NK3) receptor antagonist, approved for treating menopausal hot flashes. The medication works by restoring balance between estrogen hormones and neurokinin B (NKB), a brain chemical.
It blocks specific receptors in the brain that regulate body temperature, thereby reducing the frequency and severity of hot flashes. As a non-hormonal treatment, it provides an alternative to hormone replacement therapy.
FDA Safety Warning and Liver Injury Risk
The FDA strengthened its safety warnings for Veozah in September 2024 after receiving reports of serious liver injury. The agency’s review focused on a post-marketing case where liver problems developed within approximately 40 days of starting treatment.
Medical tests revealed significantly elevated liver enzymes, with some levels exceeding ten times the normal range. The patient’s healthcare provider conducted additional testing, including ultrasound imaging and viral hepatitis screening, to rule out other potential causes.
The documented case included 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.
The patient’s liver function improved after stopping the medication.
Current Safety Requirements and Patient Monitoring
The FDA now requires specific liver function monitoring for all patients taking Veozah. Before starting treatment, healthcare providers must conduct baseline liver testing. Monthly tests are required for the first three months, followed by additional tests at months six and nine of treatment.
Healthcare providers cannot prescribe Veozah to patients whose liver enzyme levels are twice the normal upper limit. If enzyme levels reach five times the normal limit during treatment, or if both enzyme and bilirubin levels show significant elevation, treatment must be discontinued.
Patients should be aware of warning signs that require immediate medical attention: 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. Promptly stopping the medication when these symptoms occur may prevent worsening liver damage.
Protecting Patient Rights After FDA Safety Updates
Patients who experience serious health complications while taking prescription medications have important legal rights that may need to be protected. When pharmaceutical companies update safety warnings after adverse events occur, it becomes particularly important to evaluate whether earlier warnings could have prevented harm. For Veozah patients, proper documentation of liver testing and monitoring is especially crucial to understanding potential legal options.
Medical records should document:
- Whether required baseline liver testing was conducted
- If monthly monitoring occurred as required
- How any symptoms were evaluated and treated
- What warnings were provided about potential risks
Early consultation with experienced pharmaceutical litigation attorneys can help protect your rights while allowing for proper evaluation of these factors. Many firms offer free consultations to review your specific situation.
Important Documentation for Patient Protection
The FDA actively tracks medication safety through its MedWatch program, which allows both healthcare providers and patients to report adverse effects. These reports help identify potential safety concerns and inform updates to medication guidelines. Medical expenses, treatment records, laboratory test results, and documentation of symptoms should be carefully maintained. Healthcare providers may request additional testing or monitoring beyond the standard requirements if concerns arise.
Managing Your Health and Safety
Healthcare providers and the FDA continue to monitor and collect safety data about Veozah. The medication’s prescribing information includes detailed patient guidelines, which pharmacies provide with each prescription. These guidelines may be updated as new safety information becomes available.
Patients currently taking this medication should maintain regular contact with their healthcare providers and attend all scheduled monitoring appointments. Keeping detailed medical records, including copies of test results and documentation of any symptoms or side effects, can help ensure proper care and informed decision-making about treatment options.
Staying Informed and Getting Help
The FDA maintains updated safety information about Veozah through its drug safety communication system. Staying informed about medication safety requires reliable information from multiple sources. Your healthcare provider serves as the primary resource for medical guidance and can help evaluate your individual situation.
Patients can sign up for FDA email alerts about drug safety communications to receive updates about Veozah and other medications. Patient advocacy organizations offer educational resources and support networks.
If you experienced liver complications while taking Veozah, consider speaking with legal professionals who focus on pharmaceutical cases to understand your options. Complete the form below for a confidential review of your situation.
Vehoza Claim Review
Disclaimer: This information is provided for informational purposes only and reflects FDA safety communications as of September 2024. Consult a healthcare professional for medical concerns and a qualified attorney for legal advice pertaining to your specific circumstances.