FDA: Veozah, First Hormone-Free Hot Flash Drug, Issued Black Box Warning

Follow Drugslib on

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 18, 2024.

By India Edwards HealthDay Reporter

WEDNESDAY, Dec. 18, 2024 -- The U.S. Food and Drug Administration (FDA) has issued its most serious warning -- a black-box warning -- for Veozah, a medication used to relieve hot flashes in menopausal women, due to rare but potentially severe liver risks.

In new communication issued Dec. 17, the FDA advised that women taking Veozah should undergo regular blood testing to monitor liver health.

Warning signs of liver injury can include fatigue, nausea, vomiting, dark urine, light-colored stool, or yellowing of the skin or eyes, a news release says.

Patients experiencing these symptoms should immediately stop taking the medication and consult with their doctor.

“It’s important to note that the overall benefit-risk of Veozah has not changed and remains positive, but we want to further ensure that patients and healthcare providers are aware of the potential side effects,” as well as recommended lab testing, Astellas Pharma, the manufacturer of the drug, said in a statement.

Veozah was approved in 2023. At the time, it was the first non-hormonal prescription option for treating hot flashes.

The medication works by blocking neurokinin B, a receptor involved in the brain’s regulation of body temperature.

Since its approval, the drug's popularity has grown steadily, with nearly 29,000 prescriptions filled in May 2024 alone, according to FDA data.

The FDA’s heightened warning comes after reviewing a recent case where a patient developed elevated liver markers after taking Veozah for about 40 days.

The patient’s symptoms resolved, and liver function normalized after stopping the medication.

To minimize risk, the FDA recommends monthly blood tests for liver markers during the first three months of Veozah treatment and follow-up tests at months six and nine.

Because medication effects can vary widely due to health, genetics, and other factors, the FDA emphasized that it is difficult to predict who might develop liver issues.

Sources

  • U.S. Food and Drug Administration (FDA), release, Dec. 16 2024
  • CNN, report, Dec. 17, 2024

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2024-12-19 00:00

    Read more

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords