Latest news with #HormoneReplacementTherapy
The Hindu
3 days ago
- Health
- The Hindu
US may revise hormone replacement therapy warnings
US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels on Hormone Replacement Therapy, following testimony from experts who said the treatment's risks have long been exaggerated. HRT is taken to replace estrogen the body stops producing after menopause -- when periods end permanently -- and helps relieve symptoms such as hot flashes, vaginal discomfort, and pain during sex. But its use has plummeted in recent years amid concerns including a possible link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, told AFP: "We have to revisit these topics." He argued that the framework that led to so-called "black box warnings" -- the strongest warning the FDA can require for prescription drugs -- "came from a different era." "Not only is there no clinical trial showing an increase in breast cancer mortality, but there are also other tremendous long term health benefits," Makary added. The 12 experts convened by the agency said HRT's benefits go beyond easing menopausal symptoms. They cited evidence for reduced fracture risk, improved cardiovascular and cognitive health, and fewer urinary tract infections. "Estrogen is the only well-established intervention to reduce the frequency of osteoporotic fracture in postmenopausal women, to the tune of 30 to 50 percent," said Vonda Wright, an orthopedic surgeon at the University of Central Florida. Roberta Diaz Brinton, director of the Center for Innovation in Brain Science, said her research suggests the reason two-thirds of people globally with Alzheimer's are women is not because they live slightly longer than men, but because the disease begins during the menopausal transition. "Depending upon when hormone therapy is introduced... there's a significant reduction in risk of developing Alzheimer's disease," she said. The University of Arizona researcher linked menopause to a drop in the brain's ability to metabolize glucose and a rise in protein plaque deposits. Panelists blamed the collapse in HRT use on the Women's Health Initiative (WHI), a landmark clinical trial halted in 2002 after flagging a possible increased breast cancer risk -- findings they say were misinterpreted. "Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," Makary said in his opening remarks, mentioning his own mother's experience of multiple bone fractures in old age. Critics of the WHI argue it included participants well past menopause -- when risks are higher and benefits lower -- and used outdated formulations no longer common today. Label changes Still, the issue remains divisive within the medical community. HRT can be administered through various means including orally, through skin patches, or vaginally; and is given either as estrogen alone or with progesterone. The FDA's own warning label for it cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. Adriane Fugh-Berman, who directs a project that promotes rational prescribing at Georgetown University, attended as an observer and criticised the lack of dissenting voices. "This was a very one-sided panel of people who are all proponents of hormone therapy and who seem to have a very poor understanding of the evidence," she told AFP. "While hormones can be a useful treatment for severe menopausal symptoms, they should not be used for chronic disease prevention," she added, noting that no randomised clinical trial -- the gold standard of evidence -- has found HRT beneficial for cognition or dementia prevention. She also said that after the WHI findings were released, hormone use fell globally -- and breast cancer rates dropped across registries tracking them. Several of the panelists had ties to companies offering menopause treatments or are affiliated with the advocacy group "Let's Talk Menopause," which receives pharmaceutical funding and campaigns to revise FDA warning labels.
Al-Ahram Weekly
3 days ago
- Health
- Al-Ahram Weekly
Experts to revise hormone replacement therapy warnings - Health - Life & Style
US Food and Drug Administration Commissioner Marty Makary signaled that he is open to revising strict warning labels on Hormone Replacement Therapy, following testimony from experts who said the treatment's risks have long been exaggerated. HRT is taken to replace estrogen the body stops producing after menopause -- when periods end permanently -- and helps relieve symptoms such as hot flashes, vaginal discomfort, and pain during sex. But its use has plummeted in recent years amid concerns including a possible link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, told AFP: "We have to revisit these topics." He argued that the framework that led to so-called "black box warnings" -- the strongest warning the FDA can require for prescription drugs -- "came from a different era." "Not only is there no clinical trial showing an increase in breast cancer mortality, but there are also other tremendous long term health benefits," Makary added. The 12 experts convened by the agency said HRT's benefits go beyond easing menopausal symptoms. They cited evidence for reduced fracture risk, improved cardiovascular and cognitive health, and fewer urinary tract infections. "Estrogen is the only well-established intervention to reduce the frequency of osteoporotic fracture in postmenopausal women, to the tune of 30 to 50 percent," said Vonda Wright, an orthopedic surgeon at the University of Central Florida. Roberta Diaz Brinton, director of the Center for Innovation in Brain Science, said her research suggests the reason two-thirds of people globally with Alzheimer's are women is not because they live slightly longer than men, but because the disease begins during the menopausal transition. "Depending upon when hormone therapy is introduced... there's a significant reduction in risk of developing Alzheimer's disease," she said. The University of Arizona researcher linked menopause to a drop in the brain's ability to metabolize glucose and a rise in protein plaque deposits. Panelists blamed the collapse in HRT use on the Women's Health Initiative (WHI), a landmark clinical trial halted in 2002 after flagging a possible increased breast cancer risk -- findings they say were misinterpreted. "Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," Makary said in his opening remarks, mentioning his own mother's experience of multiple bone fractures in old age. Critics of the WHI argue it included participants well past menopause -- when risks are higher and benefits lower -- and used outdated formulations no longer common today. Still, the issue remains divisive within the medical community. HRT can be administered through various means including orally, through skin patches, or vaginally; and is given either as estrogen alone or with progesterone. The FDA's own warning label for it cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. Adriane Fugh-Berman, who directs a project that promotes rational prescribing at Georgetown University, attended as an observer and criticized the lack of dissenting voices. "This was a very one-sided panel of people who are all proponents of hormone therapy and who seem to have a very poor understanding of the evidence," she told AFP. "While hormones can be a useful treatment for severe menopausal symptoms, they should not be used for chronic disease prevention," she added, noting that no randomized clinical trial -- the gold standard of evidence -- has found HRT beneficial for cognition or dementia prevention. She also said that after the WHI findings were released, hormone use fell globally -- and breast cancer rates dropped across registries tracking them. Several of the panelists had ties to companies offering menopause treatments or are affiliated with the advocacy group "Let's Talk Menopause," which receives pharmaceutical funding and campaigns to revise FDA warning labels. Follow us on: Facebook Instagram Whatsapp Short link:
eNCA
5 days ago
- Health
- eNCA
US may revise hormone replacement therapy warnings
WASHINGTON - US Food and Drug Administration Commissioner Marty Makary signalled that he is open to revising strict warning labels on Hormone Replacement Therapy, following testimony from experts who said the treatment's risks have long been exaggerated. HRT is taken to replace estrogen, the body stops producing after menopause -- when periods end permanently -- and helps relieve symptoms such as hot flashes, vaginal discomfort, and pain during sex. But its use has plummeted in recent years amid concerns, including a possible link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, told AFP: "We have to revisit these topics." He argued that the framework that led to so-called "black box warnings" -- the strongest warning the FDA can require for prescription drugs -- "came from a different era." "Not only is there no clinical trial showing an increase in breast cancer mortality, but there are also other tremendous long-term health benefits," Makary added. The 12 experts convened by the agency said HRT's benefits go beyond easing menopausal symptoms. They cited evidence for reduced fracture risk, improved cardiovascular and cognitive health, and fewer urinary tract infections. "Estrogen is the only well-established intervention to reduce the frequency of osteoporotic fracture in postmenopausal women, to the tune of 30 to 50 percent," said Vonda Wright, an orthopaedic surgeon at the University of Central Florida. Roberta Diaz Brinton, director of the Center for Innovation in Brain Science, said her research suggests the reason two-thirds of people globally with Alzheimer's are women is not because they live slightly longer than men, but because the disease begins during the menopausal transition. "Depending upon when hormone therapy is introduced... there's a significant reduction in risk of developing Alzheimer's disease," she said. The University of Arizona researcher linked menopause to a drop in the brain's ability to metabolise glucose and a rise in protein plaque deposits. Panellists blamed the collapse in HRT use on the Women's Health Initiative (WHI), a landmark clinical trial halted in 2002 after flagging a possible increased breast cancer risk -- findings they say were misinterpreted. "Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," Makary said in his opening remarks, mentioning his own mother's experience of multiple bone fractures in old age. Critics of the WHI argue it included participants well past menopause -- when risks are higher and benefits lower -- and used outdated formulations no longer common today. - Label changes - Still, the issue remains divisive within the medical community. HRT can be administered through various means and is given either as estrogen alone or with progesterone. The FDA's own warning label for it cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. Adriane Fugh-Berman, who directs a project that promotes rational prescribing at Georgetown University, attended as an observer and criticized the lack of dissenting voices. "This was a very one-sided panel of people who are all proponents of hormone therapy and who seem to have a very poor understanding of the evidence," she told AFP. "While hormones can be a useful treatment for severe menopausal symptoms, they should not be used for chronic disease prevention," she added, noting that no randomised clinical trial -- the gold standard of evidence -- has found HRT beneficial for cognition or dementia prevention. She also said that after the WHI findings were released, hormone use fell globally -- and breast cancer rates dropped across registries tracking them. Several of the panellists had ties to companies offering menopause treatments or are affiliated with the advocacy group "Let's Talk Menopause," which receives pharmaceutical funding and campaigns to revise FDA warning labels.
Time of India
5 days ago
- Health
- Time of India
US health experts to reassess hormone replacement therapy risks
Washington: US health authorities are set Thursday to reassess Hormone Replacement Therapy (HRT), a treatment used by menopausal women around the world but long clouded by debate over its risks. HRT is taken to replace estrogen the body stops producing after menopause -- when periods end permanently -- and helps relieve symptoms such as hot flashes and vaginal discomfort. But its use has plummeted in recent years amid concerns over rare side effects, including a potential link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, has long advocated for HRT, saying its risks have been overstated. "For decades, hormone replacement therapy for women -- that is estrogen or estrogen plus progesterone -- has helped women alleviate the symptoms of menopause, including hot flashes, dryness, mood swings, weight gain and poor sleep quality, to name a few," he said in a video. He added that when initiated within a decade of the onset of the transitional period before menopause, HRT may even reduce cognitive decline, the risk of Alzheimer's, and prevent osteoporosis and cardiovascular disease. Makary blamed the drop in HRT use on a landmark clinical trial, the Women's Health Initiative, which was halted in the early 2000s after it flagged increased risks of breast cancer and stroke. But he said subsequent studies had not replicated the findings on breast cancer. Critics of the trial argue it was flawed because the participants were too far from menopause, and that the formulations used are now outdated. Still, the issue remains divisive within the medical community. The FDA's own warning label for HRT -- which can be administered through various means including orally, through skin patches, or vaginally -- cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. This week, the American Journal of Physicians published an editorial that found limited benefits and significant harms associated with HRT. "Menopause is a positive life experience for many women and should not be medicalized," the authors concluded. The nature of the FDA expert meeting is also unusual. Unlike standard practice before the Trump administration, no agenda was publicly posted. Several of the named panelists have ties to companies offering menopause treatments or who belong to the advocacy group "Let's Talk Menopause," which receives funding from pharmaceutical companies and campaigns to revise the FDA warning label.
GMA Network
6 days ago
- Health
- GMA Network
US health experts to reassess hormone replacement therapy risks
HRT is taken to replace estrogen the body stops producing after menopause -- when periods end permanently -- and helps relieve symptoms such as hot flashes and vaginal discomfort. WASHINGTON - US health authorities are set Thursday to reassess Hormone Replacement Therapy (HRT), a treatment used by menopausal women around the world but long clouded by debate over its risks. HRT is taken to replace estrogen the body stops producing after menopause -- when periods end permanently -- and helps relieve symptoms such as hot flashes and vaginal discomfort. But its use has plummeted in recent years amid concerns over rare side effects, including a potential link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, has long advocated for HRT, saying its risks have been overstated. "For decades, hormone replacement therapy for women -- that is estrogen or estrogen plus progesterone -- has helped women alleviate the symptoms of menopause, including hot flashes, dryness, mood swings, weight gain and poor sleep quality, to name a few," he said in a video. He added that when initiated within a decade of the onset of the transitional period before menopause, HRT may even reduce cognitive decline, the risk of Alzheimer's, and prevent osteoporosis and cardiovascular disease. Makary blamed the drop in HRT use on a landmark clinical trial, the Women's Health Initiative, which was halted in the early 2000s after it flagged increased risks of breast cancer and stroke. But he said subsequent studies had not replicated the findings on breast cancer. Critics of the trial argue it was flawed because the participants were too far from menopause, and that the formulations used are now outdated. Still, the issue remains divisive within the medical community. The FDA's own warning label for HRT -- which can be administered through various means including orally, through skin patches, or vaginally -- cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. This week, the American Journal of Physicians published an editorial that found limited benefits and significant harms associated with HRT. "Menopause is a positive life experience for many women and should not be medicalized," the authors concluded. The nature of the FDA expert meeting is also unusual. Unlike standard practice before the Trump administration, no agenda was publicly posted. Several of the named panelists have ties to companies offering menopause treatments or who belong to the advocacy group "Let's Talk Menopause," which receives funding from pharmaceutical companies and campaigns to revise the FDA warning label. — Agence France-Presse
