The agency added recommendations for healthcare professionals and patients about increasing the frequency of liver blood testing, adding monthly testing for the next two months after starting Veozah and then at months three, six and nine, according to a Dec. 16 news release from the agency.
If patients experience symptoms of liver injury including unusual fatigue, nausea, yellowing of the skin or eyes, or dark urine, they are advised to stop taking the medication immediately and to contact a healthcare provider.
Veozah, a non-hormonal prescription medicine approved in May 2023, is classified as a neurokinin 3 receptor antagonist and helps reduce the severity and frequency of moderate to severe hot flashes by regulating body temperature, the release said.
In an email shared with Becker’s, Astellas stated, “Patient safety is Astellas’ top priority, and we work regulary with the FDA and other regulatory authorities to monitor the safety profile of our medications, which may include updating product labels, as we have previously seen. After further discussions with the FDA about the rare, but serious, adverse events related to liver injury, we have added a boxed warning to the U.S. prescribing information about the risk of hepatoxicity.”
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