Understanding the FDA Boxed Warning and Liver Risk
In December 2024, the FDA added a Boxed Warning, also known as a black box warning, to Veozah's label due to the known risk of rare but serious liver injury. This decision followed a post-marketing report of a patient experiencing liver injury symptoms after starting the medication, which resolved upon stopping the drug. The FDA advises that stopping the medication if liver injury symptoms appear may prevent the condition from worsening and allow liver function to recover. This underscores the importance of proactive monitoring for safe use.
Required Liver Function Monitoring
Due to the potential for liver injury, specific blood tests are mandatory for patients taking Veozah. Healthcare providers must assess baseline liver function before treatment begins. Regular follow-up tests are then necessary to monitor for any changes.
- Before starting treatment: Conduct baseline hepatic laboratory tests.
- Monthly for the first three months: Perform follow-up blood tests.
- At six and nine months: Repeat hepatic laboratory tests.
Patients should also be aware of and immediately report symptoms of liver injury to their healthcare provider. These symptoms can include new or increased fatigue, nausea, vomiting, unusual itching, yellowing of the skin or eyes (jaundice), pale stools, or dark urine.
How Veozah Works: A Non-Hormonal Approach
Veozah is a non-hormonal treatment for moderate to severe hot flashes and night sweats associated with menopause. Its active component, fezolinetant, functions as a neurokinin 3 (NK3) receptor antagonist.
- Targeting Temperature Control: Menopause-related estrogen decline can disrupt the brain's thermoregulatory center, leading to hot flashes.
- Blocking NKB: Veozah works by blocking the action of neurokinin B (NKB), a brain chemical involved in temperature regulation. By targeting the NK3 receptor, Veozah helps restore balance and stabilize body temperature.
This provides an alternative to Hormone Replacement Therapy (HRT) for women who cannot or prefer not to use hormonal treatments.
Common and Less Common Side Effects
Aside from the serious liver risk, other side effects of Veozah are typically mild.
Common side effects include:
- Abdominal pain
- Diarrhea
- Insomnia
- Back pain
- Hot flashes or flushes (may initially intensify for some)
Other considerations:
- Headache: Headaches have been reported. Simple pain relief or relaxation may help.
- Dehydration: Diarrhea can lead to dehydration; maintaining adequate hydration is important.
- Dosage Timing: Taking the daily dose in the morning might help alleviate insomnia.
Comparison: Veozah vs. Hormone Replacement Therapy (HRT)
Comparing Veozah to HRT is essential for women considering treatment for menopausal symptoms. The best choice depends on individual health factors and symptoms.
| Feature | Veozah (Fezolinetant) | Hormone Replacement Therapy (HRT) |
|---|---|---|
| Mechanism | Non-hormonal, blocks neurokinin 3 (NK3) receptor. | Replaces estrogen and sometimes progesterone. |
| Symptom Relief | Primarily targets moderate to severe hot flashes and night sweats. | Addresses a broader range of symptoms, including hot flashes, night sweats, vaginal atrophy, and bone density loss. |
| Safety Profile | Rare but serious risk of liver injury (Boxed Warning), requiring regular monitoring. | Potential risks include blood clots, certain cancers, and cardiovascular issues. |
| Ideal Candidates | Women who cannot or prefer not to use hormonal therapies. | Women seeking comprehensive symptom management after discussing risks/benefits with a doctor. |
| Onset of Action | Relief typically within 4 weeks. | Varies depending on type and individual response. |
| Monitoring | Mandatory liver function blood tests before and during treatment. | Varies; regular check-ups and screenings are standard. |
Drug Interactions and Contraindications
To ensure safe use, inform your healthcare provider about all medications and supplements you take before starting Veozah. Certain substances can increase the risk of side effects by affecting how the body processes the drug.
Contraindications
Veozah is not suitable for individuals with certain health conditions:
- Known cirrhosis
- Severe renal impairment or end-stage renal disease
- Known allergy to fezolinetant or its ingredients
Drug Interactions to Avoid
Veozah is metabolized by the enzyme CYP1A2. Inhibitors of this enzyme can increase Veozah levels, raising the risk of side effects. Avoid taking Veozah with CYP1A2 inhibitors, including:
- Fluvoxamine
- Ciprofloxacin
- Mexiletine
- Combined hormonal birth control pills containing ethinyl estradiol
Exercise caution with over-the-counter pain relievers. Avoid acetaminophen unless directed by a doctor due to an increased risk of liver damage when combined with Veozah. Supplements like piperine, which inhibits CYP1A2, should also be avoided.
Conclusion: Making an Informed Decision
So, is Veozah safe to take? While Veozah provides an effective non-hormonal option for managing hot flashes for many women, it carries risks, notably the rare but serious liver injury highlighted by the FDA's Boxed Warning. Adhering to medical advice and the required liver function monitoring schedule, particularly in the initial nine months, is crucial. By carefully weighing the benefits against the risks, discussing your health history and medications with your doctor, and being alert for any symptoms of concern, you can make an informed decision about using Veozah for your menopausal treatment.
For additional details on the FDA's safety communication regarding Veozah, please refer to the official statement.
