United States: The U.S. FDA has now put a black-box warning regarding the medication Veozah for menopausal hot flashes as it contains certain rare side effects that may pose serious liver hazards.
Heightened Safety Measures
In a new communication released on December 17, the FDA stated that women taking Veozah should have their blood checked regularly to assess liver function, as reported by HealthDay.
Late signs include weakness, vomiting, pale or dark stools or urine, or yellowing of the skin or eyes, according to a media release.
Manufacturer’s Statement
Any patient who develops such symptoms should discontinue the use of the medication and see their physician.
“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 well aware of the potential side effects,” as well as recommended lab testing, Astellas Pharma, the manufacturer of the drug, said in a statement.
Veozah’s Background and Usage
Veozah was approved in 2023. Back then, it was the only pharmaceutical remedy that did not contain hormones to address hot flashes.
Neurokinin B is a receptor within the brain that manages the body’s temperature, and the medication obstructs this receptor and thus functions.
It became used permanently after that; for example, approximately 29,000 prescriptions were written for the drug in May 2024, as stated by FDA.
The FDA has intensified its warning, which comes after the review of a recent incident in which a patient developed liver enlarged liver enzymes after using Veozah for roughly forty days.
The patient’s signs and symptoms improved, as did liver function when the medication was discontinued.
Regular Blood Tests Recommended
For safety considerations, the FDA decreed that clients should have a series of liver profile blood tests every month for the first three months of the Veozah treatment and then after three, six, and nine months, respectively, as reported by HealthDay. Since the effects of medicines may differ depending on one’s health condition, genetic makeup, and other factors, the FDA stated that it is impossible to determine who would experience live