An urgent warning has been issued over a common menopause drug over its potentially fatal side effects.
The US drug 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 is developed by Japanese drugmaker Astellas Pharma.
It was approved for marketing in May 2023 to treat hot flashes and night sweats, which are common symptoms of menopause.
As of May 2024, an estimated 28,700 patients received Veozah at U.S. outpatient retail pharmacies.
In the UK, the drug was licensed for use in December last year, however it is only available by private prescription and costs around £75 for a monthly supply.
Now, the FDA warns that oral tablets can cause “rare but serious liver injuries.”
Women have been advised to stop taking the medication immediately if they experience symptoms of liver disease and to contact their healthcare provider.
The FDA notes that signs of liver problems may include feeling more tired than usual, nausea, vomiting, unusual itching, light-colored stools, yellowing of the eyes or skin, dark urine, swelling of the stomach, or pain in the lower back. right upper abdomen.
The FDA has placed its most serious warning, called a boxed warning, on the nonhormonal drug fezolinetant, which is sold under the brand name Veozah.
Meanwhile, healthcare professionals have been advised to perform liver function tests before prescribing Veozah to patients.
These blood tests should be done every month for the first three months of treatment and then at six and nine months.
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 warn them about the need for testing. of blood from the liver regularly.
“Discuss signs and symptoms of liver injury and instruct patients to stop Veozah immediately and contact the healthcare professional who prescribed the medication if they develop them at any time during treatment.”
The four stages of liver disease begin with inflammation and progress to liver failure, also called end-stage liver disease.
After inflammation occurs, healing is the second stage in which healthy liver tissue turns into scar tissue.
This makes it difficult for the liver to function properly, but it is usually reversible.
The next stage is called cirrhosis, when the liver is severely and permanently scarred, which can lead to liver failure and transplant is the only option.
The FDA first warned in September that the drug could cause liver problems.
The warning was intensified after reviewing a case involving a person with blood markers of liver injury who had been taking the drug for about 40 days.
After stopping the drug, the patient’s symptoms gradually disappeared and his liver function returned to normal.
Veozah is not a hormone and instead targets the brain activity that causes hot flashes during menopause.
One 45 milligram 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 flashes, and liver inflammation.
Veozah should not be used with CYP1A2 inhibitors used to treat OCD, and patients with known cirrhosis, severe kidney damage, or end-stage renal disease should also avoid it.
TO study The Mayo Clinic estimated that menopause costs American employers at least $27 billion a year in sick days and health care costs.
Experts said the figures show it is in employers’ best interests to improve menopause support in the workplace to reduce the financial burden, such as menopause-specific sick leave and flexible working hours.