The symptoms of menopause can have a big impact on your life, from mood swings to period pain, from joint pain to weight gain. One of the most notorious problems is hot flashes, which can happen at any time. While the U.S. Food and Drug Administration (FDA) approved a new drug to address this condition in May 2023, they have now placed a black box warning on the label due to the rare risk of severe liver damage.
On Monday, December 16, the FDA issued the most prominent and serious warning for Veozah (fezolinetant), a Black Box Warning, to highlight the rare or documented risk of liver injury.
How should those taking menopause medications respond to this news? As always, discuss your individualized care with your doctor first and most important. Second, the FDA recommends that people taking Veozah get regular blood tests to check for signs of liver damage. Specifically, the FDA now recommends testing two months after starting Veozah, and then at the third, sixth, and ninth months of treatment.
Additionally, the FDA states that people who develop evidence of liver injury should stop taking the drug immediately: “If there are signs and symptoms suggesting liver injury, discontinuing the drug can prevent worsening of the liver injury and potentially allow liver function to return to normal.”
Symptoms of liver damage may include:
- fatigue
- nausea
- Vomit
- Unusual itching
- light color stool
- Yellowing of the eyes or skin (jaundice)
- dark urine
- abdominal swelling
- right upper abdominal pain
This decision is made following an incident in a specific patient.
“We made this update after reviewing a postmarketing report of a patient who developed elevated liver blood test values and signs and symptoms of liver injury approximately 40 days after taking the drug,” the FDA wrote on its website. ”
The drug’s manufacturer, Astellas, released a statement about its drug encouraging patients to learn about side effects and updated recommended liver testing.
“It is important to note that the overall benefit-risk profile of Veozah has not changed and remains positive, but we want to further ensure patents and healthcare providers are aware of Veozah’s potential side effects,” said Sarah Jacobson, director of communications at Astellas. Veozah and the Liver Laboratory test as it helps reduce moderate to severe vasomotor symptoms caused by menopause.
Veozah is a non-hormonal menopausal medication that blocks NK3 receptors and helps control body temperature. This restores the balance between estrogen levels and the brain chemical neurokinin B.
You can read the full black box warning announcement here.
