Highest possible warning issued about menopause drug causing organ failure

An urgent warning has been issued over a commonly used menopausal drug due to its potentially fatal side effects.

The FDA has posted its most serious warning — a so-called black box warning — for the non-hormonal drug fezolinetant, which is sold under the brand name Veozah and is being developed by Japanese drugmaker Astellas Pharma.

It was approved for the market 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 were dispensed Veozah through U.S. outpatient pharmacies.

However, the FDA now warns that the oral tablets can cause “rare but serious liver injury.”

Women have been advised to immediately stop taking the medication if they experience symptoms of liver disease and contact their healthcare provider.

The FDA notes that signs of liver problems may include feeling more tired than normal, nausea, vomiting, unusual itching, light-colored stools, yellowing of the eyes or skin, dark urine, swelling in the stomach, or pain in the upper right abdomen .

Meanwhile, healthcare professionals have been advised to perform liver function tests before prescribing Veozah to patients.

These blood tests should then be carried out every month for the first three months of treatment, and then after six and nine months.

The FDA instructs: ‘If prescribing Veozah, inform patients of the risk of elevated liver blood test values ​​that may occur during treatment and the rare but serious risk of liver damage, and advise them of the need for regular liver blood tests.

‘Discuss the signs and symptoms of liver damage and instruct patients to stop Veozah immediately and contact the healthcare professional who prescribed the medicine if they develop these 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 in which healthy liver tissue turns into scar tissue.

This makes it harder for your liver to work properly, but it is often reversible.

The next stage is called cirrhosis, where 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 damage who had taken the medication for about 40 days.

After stopping the drug, the patient’s symptoms gradually disappeared and 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 each 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.

A study estimated by the Mayo Clinic that menopause costs American employers at least $27 billion annually in sick days and health care costs.

Experts say the figures show it is in employers’ best interests to improve menopause support in the workplace to reduce economic burdens such as menopause-specific sick leave and flexible working hours.