The FDA issued a warning regarding the potential risk of a rare but serious liver injury associated with the drug Veozah, a medication approved in May 2023 to treat moderate to severe hot flashes.
The warning comes after a report of a patient who experienced significant liver injury symptoms after about 40 days of use, according to a Sept. 12 news release from the agency.
An Astellas spokesperson told Becker's, "Astellas remains dedicated to ensuring Veozah is accessible for appropriate patients who may benefit from a non-hormonal treatment option proven to reduce the frequency and severity of moderate to severe vasomotor symptoms (VMS) due to menopause."
The FDA has updated the prescribing information for Veozah, advising more frequent liver blood testing during the first months of treatment. Healthcare providers are also instructed to perform regular liver function tests before and during treatment as well as educate patients about risks.