(READ) FDA adds Boxed Warning to hot flash drug


The following is from MedPage Today.


The FDA has added a boxed warning to fezolinetant (Veozah), a hormone-free treatment for menopause-related hot flashes, citing the risk of rare but severe liver injury. The warning follows an initial drug safety communication warning in September that revealed a case of significant liver damage associated with the drug.

The patient experienced elevated liver enzyme levels within 40 days of starting fezolinetant. Symptoms included fatigue, nausea, decreased appetite, itching, jaundice, pale feces, and dark urine. The FDA confirmed the liver injury was related to the drug, and the patient’s symptoms improved after discontinuing use.

Prescribing recommendations now require baseline liver function tests before starting the medication, with follow-up testing advised monthly for the first three months, then at six and nine months. The FDA also recommends discontinuing fezolinetant if enzyme levels exceed five times the upper normal limit.

Patients are urged to seek immediate medical attention if they experience signs of liver injury such as jaundice, abdominal swelling, dark urine, or light-colored feces. The FDA emphasized the importance of monitoring liver health to minimize risks associated with the drug.

Approved in May 2023, fezolinetant is the first non-hormonal option for managing moderate to severe hot flashes caused by menopause. The new boxed warning underscores ongoing concerns about drug safety and the importance of rigorous monitoring.

Read the full article here.

Read the FDA’s full communication here or below.

09-12-2024 FDA Drug Safety Communication

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause

Stop medicine if signs and symptoms of liver injury occur

What safety concern is FDA announcing?

The U.S. Food and Drug Administration (FDA) is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal.

What is FDA doing?

We added a warning about the risk of liver injury to the existing warning about elevated liver blood test values and required liver blood testing in the prescribing information for Veozah.

We made this update after reviewing a postmarketing report of a patient with elevated liver blood test values and signs and symptoms of liver injury after taking the medicine for about 40 days. We also added new recommendations for patients and health care professionals about increasing the frequency of liver blood testing, adding monthly testing for the next 2 months after starting Veozah, and then at months 3, 6, and 9 of treatment as already recommended.

The updated prescribing information also instructs patients to stop the medicine immediately and contact the health care professional who prescribed the medicine if signs and symptoms of liver injury occur.

What is Veozah (fezolinetant) and how can it help me?

Veozah (fezolinetant) is a nonhormonal prescription medicine approved in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. The medicine is in a drug class called neurokinin 3 (NK3) receptor antagonists. It works to restore the balance between estrogen hormones and a brain chemical called neurokinin B (NKB) by blocking the activities of the NK3 receptor, which plays a role in the brain’s control of body temperature.

What should patients and parents/caregivers do?

Patients should stop taking Veozah immediately and contact your health care professional who
prescribed the medicine if you experience signs and symptoms that suggest liver problems. These
include feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing
of the eyes or skin, called jaundice; dark urine; swelling in the stomach or belly area, called the
abdomen; or pain in the right upper abdomen. Your health care professional will do blood tests before
starting Veozah and during treatment to check and monitor how well your liver is working. Talk to your
health care professional about the risks and benefits of taking Veozah and discuss any questions or
concerns you may have, including about possible alternative treatments.

What should health care professionals do?

Health care professionals should conduct hepatic laboratory testing before prescribing Veozah, then
every month for the first three months after patients start treatment, and then at months 6 and 9 of
treatment. When prescribing Veozah, inform patients about the risk of elevated liver blood test values that may occur during treatment and the rare but serious risk of liver injury, and advise them of the
need for regular liver blood testing. Discuss the signs and symptoms of liver injury and instruct patients
to stop Veozah immediately and contact the health care professional who prescribed the medicine if
they develop these any time during treatment.

What did FDA find?

We reviewed a postmarketing case* of serious liver injury in a patient who experienced symptoms of
fatigue, nausea, itching, yellow eyes and skin, light-colored stools, and dark urine within 40 days of
starting Veozah. The patient’s liver blood test values were elevated, including abnormal liver enzymes
and bilirubin levels. After stopping the medicine, the patient’s symptoms gradually went away, and
blood test values slowly returned to normal.

The case was reported to the FDA Adverse Event Reporting System (FAERS) database.

What is my risk?

All medicines have side effects even when used correctly as prescribed. It is important to know that
people respond differently to all medicines depending on their health, the diseases they have, genetic
factors, other medicines they are taking, and many other factors. As a result, we cannot determine how
likely it is that someone will experience these side effects when taking Veozah (fezolinetant). Your
health care professionals know you best, so talk to them if you have questions or concerns about risks of
taking Veozah (fezolinetant).

How do I report side effects from Veozah (fezolinetant)?

To help FDA track safety issues with medicines, we urge patients and health care professionals to report
side effects involving Veozah (fezolinetant) or other medicines to the FDA MedWatch program using the
information in the “Contact FDA” box at the bottom of this page.

How can I get new safety information on medicines I’m prescribing or taking?

You can sign up for email alerts about Drug Safety Communications on medicines or medical specialties
of interest to you.

Facts about Veozah (fezolinetant)

Veozah is a nonhormonal prescription medicine approved by FDA to reduce moderate to severe
hot flashes due to menopause. It is in the class of medicines called neurokinin 3 (NK3) receptor
antagonists.

  • Veozah works to restore the balance between estrogen hormones and a brain chemical called
    neurokinin B (NKB) by blocking the activities of the NK3 receptor, which plays a role in the
    brain’s regulation of body temperature.
  • Veozah is available as a tablet taken by mouth once daily.
  • Common side effects include stomach pain, diarrhea, difficulty sleeping, back pain, hot flashes,
    or hot flushes.
  • Veozah use in the U.S. has steadily increased since approval in May 2023. In May 2024, an
    estimated 28,700 patients were dispensed Veozah from U.S. outpatient retail pharmacies.i

Additional Information for Patients

  • FDA is warning that Veozah (fezolinetant), a medicine used to treat moderate to severe hot
    flashes due to menopause, can cause rare but serious liver injury and we added a warning about
    this rare but serious risk of liver injury in the prescribing information for the medicine.
  • Stop taking Veozah immediately and contact your health professional who prescribed the
    medicine if you experience signs and symptoms that suggest liver problems. These may include
    feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing
    of the eyes or skin, called jaundice; dark urine; swelling in the stomach or belly area, called the
    abdomen; or pain in the right upper abdomen. Stopping the medicine if there are signs and
    symptoms that suggest liver injury could prevent worsening liver injury and potentially return
    liver function to normal.
  • Before prescribing Veozah, health care professionals will do blood tests to check and monitor
    how well your liver is working. Health care professionals will also do these blood tests every
    month for the first 3 months after you start taking the medicine, and then again at 6 and 9
    months of treatment. If liver blood test values are elevated, the health care professional may
    advise you to stop treatment or request additional blood tests.
  • Read the patient information leaflet you receive from the pharmacy every time you receive a
    prescription for Veozah (fezolinetant) because there may be new or important additional
    information about the medicine. The patient information leaflet explains the important things
    you need to know about the medicine. These include the side effects, what the medicine is used
    for, how to take and store it properly, and other things to watch out for when you are taking the
    medicine.
  • For more information about menopause and how to treat the symptoms, visit the following FDA
    website on Menopause.
  • To help FDA track safety issues with medicines, report side effects from Veozah (fezolinetant) or
    other medicines to the FDA MedWatch program using the information in the “Contact FDA” box
    at the bottom of this page.
  • You can sign up for email alerts about Drug Safety Communications on medicines and medical
    specialties of interest to you

Additional Information for Health Care Professionals

  • FDA is warning that Veozah (fezolinetant) used to treat moderate to severe hot flashes due to
    menopause can cause rare but serious liver injury. If there are signs and symptoms suggesting
    liver injury, stopping the medicine could prevent worsening liver injury and potentially return
    liver function to normal.
  • FDA added a warning about the risk of liver injury to the existing warning about elevated liver
    blood test values in the prescribing information for Veozah. We made this update after
    reviewing a postmarketing case about a patient with increased alanine aminotransferase (ALT),
    aspartate aminotransferase (AST), alkaline phosphatase (ALP) and total bilirubin and signs and
    symptoms of liver injury within 40 days of starting it. After stopping the medicine, the patient’s
    symptoms gradually resolved, and blood test values slowly returned to normal.
  • Steps to reduce the risk of liver injury cited in the prescribing information include the following.
  • Before starting Veozah, perform baseline liver blood tests to assess liver function, including
    serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct). During treatment,
    perform follow-up liver blood tests every month for the first three months, and then again at
    months 6 and 9 of treatment.
  • Do not start Veozah if the concentration of ALT, AST, or total bilirubin is equal to or exceeds two
  • times the upper limit of normal (ULN).
  • Stop Veozah if transaminases exceed five times the ULN, or if transaminases exceed three times
    the ULN and total bilirubin is more than two times the ULN.
  • Perform more frequent follow-up liver blood tests if the transaminases exceed three times the
    ULN, but the total bilirubin is not more than two times the ULN. If the liver blood test values are
    elevated, exclude alternative causes of liver injury.
  • Inform patients about the risk of elevated liver blood test values during treatment and the rare
    but serious risk of liver injury, and discuss the need for regular liver test monitoring.
  • Explain the signs and symptoms of liver problems to patients and instruct them to stop taking
    Veozah immediately and contact the health care professional who prescribed the medicine if
    they develop these symptoms and signs any time during treatment with Veozah.
  • Encourage patients to read the patient information leaflet they receive with their Veozah
    (fezolinetant) prescriptions because there may be new or important additional information
    about the medicine.
  • To help FDA track safety issues with medicines, report adverse events involving Veozah
    (fezolinetant) or other medicines to the FDA MedWatch program using the information in the
    “Contact FDA” box at the bottom of this page.
  • You can sign up for email alerts about Drug Safety Communications on medicines and medical
    specialties of interest to you.

Data Summary

FDA reviewed a postmarketing case of serious drug-induced liver injury that occurred in a patient who
received Veozah to treat menopausal hot flashes caused. Before starting Veozah, the patient’s liver
blood test levels were normal. Within 40 days of starting it, several liver blood tests values were
significantly elevated: alanine transaminase, more than 10 times of normal level; alkaline phosphatase,
more than four times of normal level; and total bilirubin, more than 3 times of normal level. The patient
reported symptoms of liver injury, including fatigue, nausea, decreased appetite, itching of hands and
feet that later spread to the entire body, jaundice, pale feces, and dark urine. The patient’s prescriber
found no abnormalities when checking for other causes of liver injury, using ultrasonography of the liver
and blood tests for viral hepatitis. With discontinuation of Veozah, the signs and symptoms gradually
resolved, and liver blood test values returned to normal. We concluded this patient had liver injury as a
result of Veozah treatment.

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1 thought on “(READ) FDA adds Boxed Warning to hot flash drug”

  1. HOT FLASHES PRIMER: Nature evolved hot flashes and is usually efficient when evolving non-threatening body symptoms. At menopause, assume first “something” needs to be flushed out as one transitions from reproductive to non-reproductive. Just like pimples at puberty. are outward signs of an important body transition. Not easy to explain why because they are an uncomfortable nuisance. But best to find out what is their function first, before chemically turning them off.

    There is ZERO research on hot flashes, and so far they cannot even connect them to estrogen levels – that was pure drugs marketing bunk to make that claim they are “fluctuating female hormones’ that cannot even be measured before, during or after a hot flash. .

    They are episodic – episodes come for while and go on their own, so if there is short-term “relief’ from them, it could be your body just cycling through them normally and NOT because of any drug or herbal. The happen gradually, then have peak intensity and then eventually fade away over a period of several years after menses cessation.

    Women who pay attention to their pattern find stress, mind body miscues, triggers them more than anything else. Those were the only chemicals changes that were found – the cortisol levels and not hormone levels in one of the very few studies ever done. Stress triggers is the best place to pay attention to – your body is sending you a message – how to better deal with the pattern of trigger messages before you would try to mask them with a with drug. What clicks in your brain in those very the few seconds before you know your the body is going to cascade into a hot flash?

    They last only a few minutes, deep breathing helps cool down the inner core and they pass. The flash moisture does not even stain clothes, even if for a few moments it leaves you dripping wet. So what in fact are they? They are not perspiration which can stain and streak clothes and has a characteristic odor. Hot flashses do not, and they do dry in a few seconds.

    This too will pass, but the damages from drugs touted for hot flashes often do not. Let nature take its course and demand real studies be done, not surrogate studies .What exactly is the chemical composition of the moisture expelled during a hot flash, not a study using surrogate sweating by overheating which they have used as a substitute for a hot flash. That is something totally different. We need answers for their function, long before they keep pushing more drugs.

    Worrisome are the hints those who chemically tried to suppress hot flashes had more breast cancer than those who did not. Keep up on the independent research – there was one MD at Wayne State a few decades ago and no one else. Stay away from any “research” by any drug or product company. Check out every single footnoted study they offer on hot flashes or any drugs on your own – what really happened according to what they claim happened in that study.

    One trick was to put younger women in the placebo part of the study and compare them to older women in the drug/product part of the study. Since younger women will have intensifying hot flashes and older women will stat having fading hot flashes, this in fact makes a completely bogus study when they claim their drug/product “helped” reduce hot flashes. No time alone increased and reduced the hot flashes. Save your money and your health.

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