FDA places its most serious warning on menopause drug due to risk of liver injury

WELL, FIVE ON YOUR MENTAL HEALTH TONIGHT, MANAGING YOUR MOOD DURING MENOPAUSE. IT CAN BE A CHALLENGE FOR MANY WOMEN IN THEIR 40S AND 50S, BUT THERE ARE TREATMENT OPTIONS. SO HERE WITH ADVICE IS DOCTOR MICHELLE DE BLASI, A PSYCHIATRIST AT TUFTS MEDICAL CENTER. GOOD TO SEE YOU, DOCTOR. NICE TO SEE YOU. YOU KNOW, WE KNOW WOMEN CAN EXPERIENCE SOME SIGNIFICANT SYMPTOMS AS THEIR PERIOD ENDS. WHICH ONES DO YOU WORRY ABOUT? YEAH. SO UNFORTUNATELY, FOR A LOT OF WOMEN, THERE’S A LOT OF NEGATIVE SYMPTOMS THAT ARE REALLY COMMON WHEN THEY’RE GOING THROUGH MENOPAUSE. AND A LOT OF THEM HAVE TO DO WITH THEIR MENTAL HEALTH. YOU KNOW, MOOD SWINGS, IRRITABILITY, ANXIETY. BUT THE BIGGEST THING TO WORRY ABOUT IS DEPRESSIVE EPISODES. SO WE KNOW THAT THERE’S NEARLY DOUBLE THE INCIDENCE OF DEPRESSIVE EPISODES AROUND MENOPAUSE. AND SO IF YOU’RE STARTING TO, YOU KNOW, FEEL MORE HOPELESS OR LOSING INTEREST IN THINGS YOU USED TO ENJOY, IT’S REALLY IMPORTANT TO MAKE SURE YOU TALK TO YOUR DOCTOR ABOUT IT TO SEE IF YOU’RE SUFFERING FROM A CLINICAL DEPRESSION THAT NEEDS FURTHER TREATMENT. YEAH, AND YOU KNOW, HORMONE REPLACEMENT THERAPY WE KNOW, IS ONE OPTION FOR TREATING MENTAL HEALTH SYMPTOMS. WHAT ELSE WOULD YOU RECOMMEND? YEAH. SO IF PEOPLE ARE SUFFERING FROM THESE MENTAL HEALTH ISSUES AROUND MENOPAUSE, YOU KNOW, LIKE I SAID, THINGS LIKE MOOD SWINGS, ANXIETY, IRRITABILITY. THE FIRST THING I RECOMMEND IS GOING BACK TO THE BASICS. YOU KNOW, MAKING SURE YOU’RE HAVING A WELL BALANCED DIET. YOU ARE EXERCISING REGULARLY. YOU’RE SLEEPING WELL AT NIGHT BECAUSE THOSE THINGS CAN GO A REALLY LONG WAY IN IMPROVING YOUR MENTAL HEALTH. BUT CERTAINLY THERE ARE OTHER THINGS AS WELL. YOU KNOW, THERE’S THERAPY, THINGS LIKE COGNITIVE BEHAVIORAL THERAPY, LEARNING MINDFULNESS TECHNIQUES. AND IF YOUR SYMPTOMS ARE REALLY SEVERE, THERE ARE ALSO MEDICATIONS THAT MAY BE ABLE TO HELP LIKE ANTIDEPRESSANTS. SO IT’S IMPORTANT TO TELL YOUR DOCTOR, WELL DO WOMEN TYPICALLY HAVE TO CONTINUE THESE MEDICATIONS THOUGH OR THERAPY FOR FOR THE REST OF THEIR LIVES? THE REALLY GREAT THING AND REASSURING THING IS THAT THE DATA SHOWS US THAT MOST WOMEN WHO ARE SUFFERING FROM SOME OF THESE SYMPTOMS ACTUALLY HAVE THOSE SYMPTOMS COMPLETELY RESOLVED, OR AT LEAST SIGNIFICANTLY LESSEN JUST WITH TIME. SO THAT’S REALLY GREAT. BUT IT MEANS THAT IF YOUR SYMPTOMS ARE PERSISTING AND AREN’T GOING AWAY, IT’S IMPORTANT TO TALK TO YOUR DOCTOR TO MAKE SURE YOU RULE OUT ANY OTHER CAUSES, LIKE THINGS LIKE THYROID CONDITIONS OR OTHER MENTAL HEALTH DISORDERS, OR JUST TO TALK TO YOUR DOCTOR ABOUT GETTING SOME RELIEF. IT’S REALLY IMPORTANT. YEAH, ABSOLUTELY.

The U.S. Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes.The FDA says women who are taking Veozah may need more frequent blood testing to check for markers of liver problems.In rare cases, the drug may seriously injure the liver, and patients with symptoms including fatigue, unusual itching, nausea, vomiting, light-colored stools, dark urine, or yellow skin or eyes should tell their doctors and stop taking the medication, the FDA said Tuesday in a drug safety communication.Astellas, the drug's manufacturer, said in a statement that patient safety is its top priority."It's important to note that the overall benefit-risk of Veozah has not changed and remains positive, but we want to further ensure that patients and healthcare providers are aware of the potential side effects," as well as recommended lab testing, the company said.Veozah was approved in 2023. It works without hormones to reduce hot flashes by blocking a receptor called neurokinin B, which plays a role in the brain's regulation of body temperature.Since its approval, use of the medication has steadily increased. In May, nearly 29,000 patients picked up the pills from retail pharmacies in the United States, the FDA said.The FDA first warned in September that the drug could cause liver problems. It escalated that warning after reviewing the case of a person with blood markers of liver injury who had been taking the medication for about 40 days. After they stopped taking the medication, the patient's symptoms gradually went away and their liver values returned to normal.Everyone reacts differently to medication depending on their health, genes and other factors. For that reason, the FDA said, it's impossible to know how likely it might be for any individual to develop these liver issues.If you're taking Veozah, it's important to stay alert and check in with your doctor for monitoring.The FDA said patients should have blood tests for liver markers every month for the first three months after starting Veozah and again at months six and nine. They should also stop treatment if it is recommended.

CNN —

The U.S. Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes.

The FDA says women who are taking Veozah may need more frequent blood testing to check for markers of liver problems.

In rare cases, the drug may seriously injure the liver, and patients with symptoms including fatigue, unusual itching, nausea, vomiting, light-colored stools, dark urine, or yellow skin or eyes should tell their doctors and stop taking the medication, the FDA said Tuesday in a drug safety communication.

Astellas, the drug's manufacturer, said in a statement that patient safety is its top priority.

"It's important to note that the overall benefit-risk of Veozah has not changed and remains positive, but we want to further ensure that patients and healthcare providers are aware of the potential side effects," as well as recommended lab testing, the company said.

Veozah was approved in 2023. It works without hormones to reduce hot flashes by blocking a receptor called neurokinin B, which plays a role in the brain's regulation of body temperature.

Since its approval, use of the medication has steadily increased. In May, nearly 29,000 patients picked up the pills from retail pharmacies in the United States, the FDA said.

The FDA first warned in September that the drug could cause liver problems. It escalated that warning after reviewing the case of a person with blood markers of liver injury who had been taking the medication for about 40 days. After they stopped taking the medication, the patient's symptoms gradually went away and their liver values returned to normal.

Everyone reacts differently to medication depending on their health, genes and other factors. For that reason, the FDA said, it's impossible to know how likely it might be for any individual to develop these liver issues.

If you're taking Veozah, it's important to stay alert and check in with your doctor for monitoring.

The FDA said patients should have blood tests for liver markers every month for the first three months after starting Veozah and again at months six and nine. They should also stop treatment if it is recommended.

FDA places its most serious warning on menopause drug due to risk of liver injury

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