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New menopause drug for hot flashes gets FDA approval
ERIKA: THERE IS NEW EVIDENCE TONIGHT THAT WOMEN WHO EXPERIENCE EARLY MENOPAUSE SHOULD START HORMONE REPLACEMENT THERAPY RIGHT AWAY TO LOWER THEIR RISK OF DEVELOPING ALZHEIMER’S. HERE TO EXPLAIN IS GILLIAN COUGHLAN, THE STUDY’S LEAD AUTHOR AND A RESEARCH FELLOW IN NEUROLOGY AT MASS GENERAL , THANKS FOR JOINING US. ED: MENOPAUSE IS A NATURAL PART OF AGING FOR WOMEN. HOW, AND WHEN, IS IT TYPICALLY DIAGNOSED? >> MENOPAUSE IS TYPICALLY DIAGNOSED ABOUT ONE YEAR AFTER A WOMAN’S LAST PERIOD. IN THE UNITED STATES, THAT IS TYPICALLY AGE 51. ERIKA: YOUR STUDY DEFINES EARLY MENOPAUSE AS HAPPENING BEFORE AGE 45 IN MOST WOMEN, AND PREMATURE MENOPAUSE WHEN IT STARTS BEFORE AGE 40. WHY DO RESEARCHERS BELIEVE THE TIMING IS A RISK FACTOR FOR ALZHEIMER’S? >> THE TIMING OF MENOPAUSE DOES SEEM TO BE IMPORTANT. IN OUR RECENT STUDY, WE LOOK AT ALZHEIMER’S DISEASE IN THE BRAIN. WHAT WE FOUND IS WHEN EARLIER PREMATURE MENOPAUSE ARE LIKELY TO HAVE HIGHER LEVELS OF ALZHEIMER’S DISEASE IN THE BRAIN, THAT MEANS THEY ARE MORE LIKELY TO SUFFER COGNITIVE DECLINE AND ONSET IN LATER LIFE. ED: DOCTORS TYPICALLY PRESCRIBE HORMONE REPLACEMENT THERAPY, OR HRT, TO TREAT SEVERE SYMPTOMS OF MENOPAUSE, SUCH AS HOT FLASHES, NIGHT SWEATS AND TROUBLE SLEEPING. WHAT DID YOUR RESEARCH DISCOVER ABOUT THE POTENTIAL RISK OF STARTING THAT MEDICATION LATER INSTEAD OF SOONER? >> IF HORMONE THERAPY WAS STARTED SEVERAL YEARS AFTER MENOPAUSE ONSET, WE FOUND THAT HORMONE THERAPY WAS ASSOCIATED WITH HIGHER RISK OF ALZHEIMER’S DISEASE, WHICH IS NOT GOOD. IF WOMEN STARTED HORMONE THERAPY CLOSER TO THEIR AGE OF MENOPAUSE, THIS RISK WAS NOT THERE. THIS IS A GOOD THING, THIS MEANS WE CAN USE HORMONE THERAPY CLOSE TO MENOPAUSE AGE TO TREAT SEVERE SYMPTOMS. WE CANNOT JUST USE IT IN OLDER WOMEN OR WOMEN WHO ARE YEARS PAST THEIR MENOPAUSE ONSET. ERIKA: AGAIN, MOST WOMEN START MENOPAUSE LATER, USUALLY SOMETIME BETWEEN AGE 45-TO-55-YEARS-OLD. WHAT’S YOUR MESSAGE TO THEM? >> THESE WOMEN ARE STARTING AT TYPICAL AGE. WHAT I WOULD SAY TO THEM IS, IF THEY WANT TO USE HORMONE REPLACEMENT THERAPY AND THEY ARE SUFFERING FROM MODERATE TO SEVERE SYMPTOMS, TALK TO YOUR DOCTOR AND TRY TO START VERY CLOSE TO WHEN YOU ARE AGE OF MENOPAUSE ACTUALLY IS AND NOT LATER DOWN THE ROAD. ED
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New menopause drug for hot flashes gets FDA approval
U.S. health regulators on Friday approved a new type of drug for women dealing with uncomfortable hot flashes caused by menopause.The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can include sweating, flushing and chills.Astellas' drug, Veozah, uses a new approach, targeting brain connections that help control body temperature. The FDA said the medication will provide "an additional safe and effective treatment option for women,” in a statement.More than 80% of women experience hot flashes during menopause, the FDA noted, as the body gradually produces lower levels of reproductive hormones between the ages of 45 and 55.The most common treatment consists of hormonal pills aimed at boosting levels of estrogen and progestin. But the treatment isn't appropriate for some women, including those with a history of stroke, blood clots, heart attack and other health conditions. Large studies have found that the hormones can increase the chances of those problems reoccurring, although the risks vary based on a number of individual factors.The new pill is not a hormone. It carries an FDA warning about potential liver damage. Women will need to be screened for liver damage or infection before getting a prescription, then get a blood test every three months for nine months to monitor for safety problems, according to the FDA label.Astellas said the drug will cost $550 for a one-month supply. That's the price before insurance coverage and other discounts typically negotiated by insurers and pharmacy benefit managers.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
U.S. health regulators on Friday approved a new type of drug for women dealing with uncomfortable hot flashes caused by menopause.
The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can include sweating, flushing and chills.
Astellas' drug, Veozah, uses a new approach, targeting brain connections that help control body temperature. The FDA said the medication will provide "an additional safe and effective treatment option for women,” in a statement.
More than 80% of women experience hot flashes during menopause, the FDA noted, as the body gradually produces lower levels of reproductive hormones between the ages of 45 and 55.
The most common treatment consists of hormonal pills aimed at boosting levels of estrogen and progestin. But the treatment isn't appropriate for some women, including those with a history of stroke, blood clots, heart attack and other health conditions. Large studies have found that the hormones can increase the chances of those problems reoccurring, although the risks vary based on a number of individual factors.
The new pill is not a hormone. It carries an FDA warning about potential liver damage. Women will need to be screened for liver damage or infection before getting a prescription, then get a blood test every three months for nine months to monitor for safety problems, according to the FDA label.
Astellas said the drug will cost $550 for a one-month supply. That's the price before insurance coverage and other discounts typically negotiated by insurers and pharmacy benefit managers.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
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