Fda Issues Warning For Veozah Menopause Drug

The U.S. Food and Drug Administration (FDA) announced on September 12th that it is issuing a warning for Veozah, a drug commonly used to treat menopause-related hot flashes.

This cautionary statement from the FDA comes after a thorough review of a case involving a severe liver injury in an individual who exhibited symptoms such as yellowing of the eyes and skin, as well as dark urine, within just 40 days of starting Veozah.

The reported symptoms resolved once the person discontinued use of the medication, and subsequent blood tests indicated a return to normal liver function.

The FDA advises users of Veozah to immediately cease taking the drug if they experience any signs or symptoms of liver injury. Such symptoms may include fatigue, nausea, jaundice, dark urine, and abdominal pain.

If patients encounter any of these symptoms, they should promptly consult their healthcare provider, who can administer relevant blood tests to assess liver health.

The FDA stresses that all medications carry potential side effects, even when used as directed. Individual responses to medications vary based on factors such as overall health, existing medical conditions, genetic predisposition, concomitant medications, and other variables. Consequently, it is difficult to predict the likelihood of experiencing side effects while taking Veozah (fezolinetant). Speaking with healthcare professionals is crucial for informed decision-making regarding the risks associated with Veozah (fezolinetant).

During the drug’s approval process, regulatory authorities recommended that patients undergo liver function tests prior to initiating Veozah therapy. Additionally, blood tests should be conducted every three months within the first nine months of medication usage to monitor liver health.

Among other reported side effects, Veozah may cause diarrhea, insomnia, and back pain.

Astellas Pharma Inc., the distributor of Veozah in the United States, stated in an emailed response to The Epoch Times that the company regularly collaborates with regulatory bodies to ensure the safety and integrity of its medications.

The company expressed commitment to enhancing the hepatic laboratory testing protocol outlined in the Veozah U.S. prescribing information. This includes identifying patients at risk for or experiencing symptoms of potential drug-induced liver injury through the addition of two extra timepoints for hepatic tests and the inclusion of further liver value assessment. Moreover, clear guidance regarding when to seek medical attention and when to discontinue Veozah has been incorporated into the labeling.