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 testing.
‘Discuss the signs and symptoms of liver injury and instruct patients to stop Veozah immediately and contact the health care professional who prescribed the medicine if they develop these any time during treatment.’
The four stages of liver disease, begin with inflammation and progress all the way to liver failure, also called end-stage liver disease.
After inflammation occurs, scarring is the second stage with healthy liver tissue turning into scar tissue.
This makes it harder for your liver to work properly, but it is often reversible.
The next stage is called cirrhosis, when your liver becomes severely and permanently scarred, and this can then lead to liver failure with a transplant being the only option.
The FDA first warned in September that the drug could cause liver problems.
It escalated the warning after reviewing a case involving a person with blood markers of liver injury who had been taking the medication for about 40 days.
After stopping the medicine, the patient’s symptoms gradually went away, and their liver function returned to normal.
Veozah is not a hormone and instead targets the brain activity which causes hot flashes during menopause.
One 45milligram pill should be swallowed once a day with or without food, at the same time every day.
The most common side effects of Veozah are abdominal pain, diarrhea, insomnia, back pain, hot flush and liver inflammation.
Veozah must not be used with CYP1A2 inhibitors used to treat OCD, and patients with known cirrhosis, severe renal damage or end-stage renal disease should also avoid it.
A study by the Mayo Clinic estimated that menopause costs US employers at least $27 billion a year through sick days and healthcare costs.
Experts said the figures demonstrate that it is in employers’ best interest to improve workplace menopause support to reduce the economic burden, such as menopause-specific sick leave and flexible working hours.