Veozah, a non-hormonal drug used to treat menopause symptoms, has been issued a black box warning by the FDA due to the risk of rare but serious liver damage. Women taking the drug should be aware of potential symptoms and seek immediate medical attention if they experience any.
An urgent warning has been issued over a common menopause drug for its potentially fatal side effects. US drugs watchdog the FDA has placed its most serious warning - called a black box warning - on the non-hormonal drug fezolinetant, which is sold under the brand name Veozah and developed by Japanese drugmaker Astellas Pharma. It was approved for market in May 2023 to treat hot flashes and night sweats, which are common symptoms of menopause.
In May 2024, an estimated 28,700 patients were dispensed Veozah from US outpatient retail pharmacies. In the UK, the drug was licensed for use in December last year, however it is only available on private prescription, costing around £75 for a month's supply. Now, the FDA is warning that the oral tablets can cause 'rare but serious liver injury'. Women have been advised to stop taking the medication immediately if they experience symptoms of liver disease and to contact their health care provider. The FDA notes that signs of liver problems can include feeling more tired than usual, nausea, vomiting, unusual itching, light-colored stools, yellowing of the eyes or skin, dark urine, swelling in the stomach or pain in the right upper abdomen. The FDA has placed its most serious warning - called a Boxed Warning - on the non-hormonal drug fezolinetant, which is sold under the brand name Veozah Meanwhile, health care professionals have been advised to perform liver function tests before prescribing Veozah to patients. These blood tests should then be performed every month for the first three months of treatment, and then at the six month and nine month marks. The FDA instructs: 'When prescribing Veozah, inform patients about the risk of elevated liver blood test values that may occur during treatment and the rare but serious risk of liver injury, and advise them of the need for regular liver blood testin
FDA Veozah Menopause Liver Injury Drug Warning
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