On Thursday, the FDA issued a warning regarding the potential for “serious liver injury” in patients taking the medication Veozah (fezolinetant). Along with the warning, the FDA released updated recommendations regarding precautions health care professionals should take when prescribing Veozah and signs and symptoms patients should look for when taking the drug.
Veozah (fezolinetant) is a medication approved to help regulate body temperature in women experiencing menopause. It is a nonhormonal drug that belongs to a class of drugs called neurokinin 3 (NK3) receptor antagonists. These drugs act on estrogen levels indirectly by blocking NK3 receptors in the body. NK3 receptors bind with a peptide called neurokinin B (NKB), which is responsible for producing hot flashes in menopausal women.
The FDA announced the warning after a report of a patient experiencing liver injury while taking Veozah for around 40 days. Prior to the FDA’s warning, health care professionals were already aware of the risk of “elevated liver function test values” and were following existing recommendations to test patients on the medication at three, six, and nine months. In the case of elevated liver function test values, health care providers would discontinue the treatment.
With the new warning, the FDA issued the following recommendations:
- In addition to the pre-existing guidelines for liver function testing prior to treatment and at three, six, and nine months, health care professionals should test every month for the first three months of treatment with Veozah (fezolinetant).
- Prescribers should educate patients about the risk of elevated liver function test values and, in rare cases, injury to the liver. It is imperative that patients understand the need for regular liver function testing.
- Health care professionals should educate patients taking Veozah (fezolinetant) about the signs and symptoms of liver injury, which can include fatigue, itching, jaundice, swelling of the abdomen, right abdominal pain, nausea and vomiting, darkened urine, and abnormally pale stools.
- Patients should understand the signs and symptoms of liver injury and should communicate regularly with their prescribing doctor about any new or unusual symptoms they are experiencing. They should stop taking Veozah (fezolinetant) immediately if such signs or symptoms occur.
Patients and health care providers can report any new adverse health events related to taking Veozah (fezolinetant) through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered liver injury after taking Veozah (fezolinetant) or another FDA-approved medication, we urge you to get in touch with our team. We can review your case and, if appropriate, help you hold the liable parties accountable for distributing a dangerous medication. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.