The U.S. Food and Drug Administration (FDA) has issued a critical warning regarding Veozah (fezolinetant), a prescription medication approved for managing hot flashes due to menopause. In a statement released on Friday, the FDA highlighted the rare but serious risk of liver injury associated with the drug. This warning follows a post-marketing report of a patient who developed signs and symptoms of liver injury after taking Veozah for about 40 days. The patient exhibited elevated liver enzyme levels and other indicators of liver dysfunction, prompting the FDA to update the prescribing guidelines for Veozah.
Veozah, which was approved in May 2023, is a nonhormonal medication that belongs to a class of drugs known as neurokinin 3 (NK3) receptor antagonists. It works by blocking the activity of the NK3 receptor, which is involved in the brain's regulation of body temperature. This mechanism helps reduce the frequency and severity of hot flashes, a common symptom of menopause. Since its approval, the drug has gained steady usage, with over 28,000 patients having been prescribed Veozah as of May 2024.
However, recent concerns have emerged regarding its safety. The FDA’s updated guidance includes new recommendations for both patients and healthcare professionals to minimize the risk of liver damage. The warning highlights the importance of conducting regular liver function tests, especially during the early months of treatment, to detect any signs of liver injury before it becomes severe.
FDA’s Findings: A Case of Liver Injury
The FDA’s warning is based on a report of a patient who experienced severe liver injury after using Veozah for around 40 days. Symptoms such as fatigue, nausea, itching, jaundice (yellowing of the skin and eyes), light-colored stools, dark urine, and pain in the upper right abdomen were observed. The patient’s liver function tests revealed elevated liver enzymes and bilirubin levels, both of which are indicators of liver stress or damage. Fortunately, after stopping the medication, the patient's liver function gradually returned to normal, though this incident raised concerns about the potential risks associated with Veozah.
To ensure patient safety, the FDA has now updated the prescribing information for the drug. It emphasizes the need for close monitoring of liver function in patients who are taking Veozah, especially during the first three months of treatment. Monthly liver function tests are recommended for the first two months, followed by additional tests at months 3, 6, and 9 to ensure the liver is functioning properly.
Recommendations for Patients
For patients taking Veozah, the FDA has issued clear guidelines. If any symptoms suggestive of liver injury occur, such as unusual fatigue, nausea, vomiting, jaundice, or abdominal pain, the medication should be stopped immediately, and the prescribing healthcare professional should be contacted. Other warning signs to watch for include itching, light-colored stools, dark urine, and swelling in the stomach area.
The FDA also urges patients to undergo liver function tests before starting the treatment and to continue monitoring liver health regularly during the course of their treatment. If any abnormalities are detected, patients may need to discontinue the medication to prevent further damage to the liver.
Guidelines for Healthcare Providers
Healthcare providers have been advised to take extra precautions when prescribing Veozah. The FDA recommends that physicians conduct hepatic laboratory testing before initiating treatment and then continue testing monthly for the first three months. Additional tests should be done at months 6 and 9 to detect any liver damage early on.
Healthcare professionals are also urged to inform patients about the potential risk of liver injury and the importance of regular testing. Patients should be made aware of the symptoms of liver dysfunction and instructed to stop taking Veozah immediately if they develop any of these symptoms.
While Veozah has been shown to effectively reduce hot flashes in women going through menopause, the FDA’s latest warning underscores the importance of monitoring liver health during treatment. With the right precautions, including regular liver function testing and vigilance regarding symptoms of liver injury, patients can continue to benefit from Veozah while minimizing the risks.
(Input from various sources)
(Rehash/Ankur Deka/MSM)
