The warning, first introduced 22 years ago, cautioned that hormone replacement therapy could raise the risk of heart disease, stroke, blood clots, dementia, and certain cancers. The FDA now says newer evidence indicates that these risks are far lower when the treatment is prescribed before age 60 or within 10 years of the onset of menopause.

“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” said Health Secretary Robert F. Kennedy Jr. during the announcement.

The revision affects widely used therapies intended to ease symptoms such as hot flashes, night sweats, and mood changes—conditions that affect millions of women during menopause.

Updated Guidelines Reflect Evolving Science

FDA Commissioner Dr. Marty Makary, who has long advocated for removing the warning, called the previous label “outdated and unnecessary.” He said the decision aligns with findings from recent studies showing that hormone therapy can be safe and beneficial for many women when used appropriately.

“With few exceptions, there may be no other medication in the modern era that can improve women’s health outcomes at a population level more than hormone replacement therapy,” Makary told reporters.

The agency’s updated prescribing information now aligns with modern medical guidelines, which recommend using hormone therapy for a limited duration among younger women without complicating risk factors such as breast cancer or blood clotting disorders.

Still, not all experts agree. Dr. JoAnn Manson of Harvard Medical School said that while removing the warning was “a good step toward personalized care,” the benefits described by Makary are “not as conclusive or definitive.”

“The black box is really one size fits all—it scares everyone away,” Manson explained. “Without it, there can be more focus on how the risks and benefits differ by age and health profile.”

A Shift from Two Decades of Caution

The FDA’s original boxed warning was based on findings from the landmark Women’s Health Initiative (WHI) study, published in 2002, which linked hormone therapy to higher rates of heart disease, blood clots, and breast cancer.

The study, involving over 26,000 women, led to a dramatic decline in hormone therapy prescriptions across all age groups. In the 1990s, roughly one in four American women used estrogen-based treatments, often believing they could prevent heart disease and dementia.

However, later analyses of the WHI data have revealed more nuanced results. A new review published in September found that women in their 50s taking estrogen-based drugs did not face an increased risk of heart problems, while risks were higher for those in their 70s. For women in their 60s, the data remained inconclusive.

“These findings suggest that timing and age at initiation make a significant difference in outcomes,” said Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists. “The old warning scared patients away even when hormone therapy might have helped them.”

Fleischman added that many women stopped seeking treatment altogether after reading the label. “I can spend 30 minutes counseling someone about hormone therapy, but when they see that warning, they just get scared,” he said.

FDA’s Review Process Sparks Criticism

Despite widespread support from some physicians, the FDA’s approach to revising the warning has drawn criticism from several health policy experts who argue that the agency bypassed its usual advisory process.

Typically, the FDA consults independent advisory committees when revising safety labels. Instead, Makary convened a smaller, informal panel of about a dozen doctors and researchers—many of whom publicly advocate for hormone therapy or have ties to pharmaceutical companies that manufacture these drugs.

Diana Zuckerman, president of the nonprofit National Center for Health Research, said the decision risks undermining public trust. “By skipping a formal scientific meeting and instead holding a news event, the FDA appears to have prioritized messaging over transparency,” she said.

Makary defended the move, arguing that advisory committee meetings are “bureaucratic, long, often conflicted, and very expensive.”

New Labeling Still Includes Cancer Advisory

Although the FDA has removed the broader black box warning, the updated labels will still contain a boxed notice advising that women who have not had a hysterectomy should take a combination of estrogen and progestin to reduce the risk of uterine cancer.

The older warning language will remain on the label but appear in a less prominent section.

Additionally, the market has evolved since the early 2000s, with newer formulations delivering hormones in lower doses and through localized delivery systems such as vaginal creams and tablets. These methods limit how much hormone circulates through the bloodstream, potentially lowering systemic risks.

Ongoing Debate Over Hormone Therapy’s Role

The controversy over hormone therapy reflects broader debates in women’s health about how medical evidence is interpreted and communicated. Advocates say the FDA’s decision could help reduce stigma and make more women comfortable discussing treatment options. Critics warn that downplaying risks could lead to overprescription.

Medical experts emphasize that hormone therapy should be prescribed on an individual basis, taking into account age, health history, and symptom severity.

“The removal of the black box is not a green light for everyone,” Dr. Manson noted. “It’s an invitation to nuanced, evidence-based decision-making.”

As hormone therapy reenters public conversation, researchers say long-term studies are still needed to confirm whether the treatment can truly reduce the risk of chronic conditions like Alzheimer’s and heart disease—claims that remain scientifically unsettled.

Source: AP News – The FDA removes a long-standing warning from hormone-based menopause drugs

The post FDA Removes Long-Standing Safety Warning from Menopause Hormone Therapy Drugs appeared first on Journos News - Breaking News, World News, Top Stories, Todays Headlines and Flash Reports.

Heavy Menstrual Bleeding Linked to Fatigue in Menopausal Women

New research has identified a potential link between heavy or prolonged menstrual bleeding and fatigue in women transitioning to menopause, shedding light on an often-overlooked symptom.

Approximately 33% of women experience heavy or prolonged menstrual bleeding during the transition to menopause. Such episodes can meet the medical definition of abnormal uterine bleeding—excessive in amount, duration, or frequency within a six-month period.

While excessive bleeding is common, research on its connection to other menopausal symptoms has been scarce. However, a new study published in the journal Menopause suggests that frequent heavy bleeding episodes are associated with increased fatigue in menopausal women.

The study, which tracked women over time, is the first to evaluate the relationship between heavy menstrual bleeding and fatigue in premenopausal and perimenopausal women. Lead author Dr. Siobán Harlow, a professor emeritus of epidemiology and obstetrics at the University of Michigan, emphasized the significance of these findings.

“Menstruation remains a subject cloaked in silence and associated with taboos, even within the realm of scientific inquiry,” Harlow stated. “Lack of dialogue about menstruation, particularly about bleeding changes as women approach menopause, leads to a lack of knowledge about what is normal.”

She hopes the findings encourage further research into links between menstrual bleeding, sleep disturbances, and cognitive issues during menopause.

Perimenopause, the phase leading up to menopause, typically lasts three to ten years. It begins when the ovaries gradually reduce hormone production, causing fluctuations in estrogen and progesterone levels. These changes can lead to irregular periods, mood swings, and other symptoms, including depression and fatigue.

The study analyzed data from 2,329 women who were, on average, 47 years old when they joined the Study of Women’s Health Across the Nation in 1996 or 1997. Over a decade, participants provided information about their menstrual and medical histories.

Women documented their menstrual bleeding monthly, noting heavy bleeding as the need to change a sanitary product every hour for over four hours. Prolonged bleeding was defined as lasting more than eight days, while heavy bleeding meant three or more days of very heavy flow.

Researchers assessed participants’ vitality and fatigue levels at multiple visits. They found that:

• Women who had at least three heavy bleeding episodes in six months were 62% more likely to feel tired and 44% more likely to feel worn out.
• Those who had prolonged bleeding were 32% less likely to feel energetic.

Dr. Stephanie Faubion, medical director of The Menopause Society, noted that while the link between heavy menstrual bleeding and fatigue may seem intuitive, it has never been formally studied before. She also pointed out that existing menopause questionnaires do not address bleeding, as menopause is defined by the absence of menstruation.

The fatigue experienced by women with heavy bleeding could stem from iron deficiency or iron deficiency anemia, conditions that result from excessive blood loss. Anemia, caused by low levels of red blood cells or hemoglobin, can lead to fatigue and other health complications.

However, the study did not measure participants’ blood iron levels, making it difficult to confirm iron deficiency as the sole cause. Faubion noted that anemia usually requires significant blood loss to develop. She also suggested other possible explanations, such as:

• Disrupted sleep due to frequent nighttime bleeding, leading to exhaustion.
• Restless leg syndrome, a condition linked to iron deficiency, which can further impair sleep quality.

The study highlights the importance of discussing menstrual irregularities with healthcare providers. Dr. Leana Wen, an emergency physician and adjunct professor at George Washington University, emphasized that women experiencing fatigue should be asked about abnormal menstrual bleeding and tested for iron deficiency.

Women going through menopause are encouraged to track their cycle length, duration of bleeding, and any perceived changes in flow to help identify potential health concerns.

If anemia is the cause of fatigue, treatment involves stopping excessive bleeding and restoring iron levels, often through oral iron supplements. Other treatment options for heavy bleeding include:

• NSAIDs (e.g., ibuprofen, naproxen) – Can reduce bleeding by 30%.
• Birth control pills – Help regulate menstrual cycles and decrease bleeding.
• Hormonal intrauterine devices (IUDs) – Reduce bleeding by up to 98%.

Additionally, restless leg syndrome, if linked to iron deficiency, can be managed by correcting iron levels.

Abnormal uterine bleeding should never go unexamined, as it can lead to significant health issues, including anemia and, in some cases, serve as an early warning sign of cancer. Experts urge medical professionals to include bleeding patterns in their assessment of menopausal symptoms and for more research to be conducted on this critical stage of a woman’s life.

Source

The post Study Reveals Hidden Cause of Fatigue in Menopausal Women appeared first on Journos News - Breaking News, World News, Top Stories, Todays Headlines and Flash Reports.

We often hear a lot about how frequently people should poop, with experts suggesting that it varies depending on various factors. But what about urination? How often should you pee, and what does your frequency say about your health?

How Often Should You Pee?

According to Dr. Jamin Brahmbhatt, a urologist at Orlando Health, the average person should urinate about six to eight times a day. Ideally, you shouldn’t be waking up at night to pee, but if you find yourself getting up more than once, it could be an indication that something isn’t quite right. During the day, it’s normal to pee every three to four hours.

However, some people may urinate up to 10 times a day, especially if they’re drinking a lot of water or beverages that stimulate frequent urination, like coffee, tea, or alcohol. These drinks can have diuretic effects that irritate the bladder. Dr. David Shusterman, a board-certified urologist, advises those bothered by frequent trips to the bathroom after drinking these beverages to cut back on caffeine or alcohol, or try diluting them.

Everyone’s body is different, and there’s no “one-size-fits-all” rule. What’s most important is knowing what’s normal for your body. If you suddenly find yourself running to the bathroom much more or much less than usual, and it’s affecting your daily life, it might be time to check in with a doctor.

Excessive Urination: What Could Be the Cause?

If you’re urinating more than usual and it’s not related to your beverage intake, several medical conditions could be to blame. Overactive bladder syndrome, diabetes, urinary tract infections (UTIs), or medications like diuretics (commonly prescribed for high blood pressure) can cause excessive urination.

Urination is controlled by a complex neurological system involving the bladder, urethra, and brain. Conditions that affect this system, like stroke, spinal cord injuries, and neurological diseases such as Parkinson’s, multiple sclerosis, and even tumors, can also lead to frequent urination.

Pregnancy can also contribute to more frequent urination since increased fluid intake and metabolic changes put more pressure on the bladder. In addition, stress and anxiety can stimulate the bladder, increasing the need to pee, as the body releases adrenaline during the fight-or-flight response.

For women, hormonal changes — especially during menopause — can affect urination. Reduced estrogen levels can lead to an overactive bladder. Dr. Jason Kim, a clinical associate professor of urology, explains that estrogen receptors are present in the bladder, which is why treatments like vaginal estrogen creams can be beneficial in managing overactive bladder symptoms.

When to Seek Help

If you notice that your frequent urination is affecting your quality of life, or if you’re waking up at night to pee regularly, it may be time to consult a urologist. They can help determine whether bladder training exercises or other treatments, such as medications, bladder Botox injections, or nerve stimulation, are necessary.

Bladder Botox, for instance, weakens the bladder’s nerves to reduce involuntary contractions and decrease the urge to urinate. This can be far more effective than medications for many patients.

Not Peeing Enough: What Does It Mean?

On the flip side, if you find that you’re only peeing every six to eight hours or less than four times a day, this could be a sign of dehydration or a problem with your bladder or kidneys. Low urinary frequency can increase your risk of developing a urinary tract infection (UTI), as regular urination helps flush out harmful bacteria.

If you’re not urinating often, make sure you’re getting enough fluids. The National Academy of Medicine recommends that women consume 2.7 liters (91 ounces) of fluids daily, and men should aim for 3.7 liters (125 ounces). This includes all fluids and water-rich foods, like fruits and vegetables.

If you’re holding it in too long, this could cause long-term damage, leading to kidney infections or weakened bladder muscles. If you are still not urinating enough despite maintaining healthy hydration, it’s time to see a doctor.

Why Aren’t You Peeing Enough?

Not urinating frequently enough could indicate an obstruction, such as a blocked urethra, or it could be a behavioral issue, especially for men as they age and experience prostate enlargement. For women, a tightened urethra could contribute to retention issues.

Neurological conditions like those mentioned earlier can also affect urinary function.

Treatment for Infrequent Urination

Unfortunately, there are fewer treatments available for underactive bladder. Depending on the cause, treatment options include self-administered catheterization, long-term catheterization, or sacral neuromodulation — a procedure that involves a bladder pacemaker to regulate urination. These treatments can be life-changing, so if you’re dealing with underactive bladder issues, don’t hesitate to seek help.

Conclusion

Your urination frequency can be a key indicator of your overall health. Whether you’re peeing more or less than usual, it’s important to understand what’s normal for you and take action if something changes. If you’re concerned, speak to a urologist who can help you get to the root of the issue and find an appropriate solution.

Source

The post Is Your Peeing Pattern Normal? Here’s What It Means appeared first on Journos News - Breaking News, World News, Top Stories, Todays Headlines and Flash Reports.

Chinese scientists have made significant progress in fertility research by using stem cell transplantation to extend the reproductive lifespan in female monkeys. This breakthrough could provide new options for women struggling to conceive, especially as the average age for having children continues to rise.

The study, conducted by researchers from the Chinese Academy of Sciences and published in Cell Discovery, addresses the issue of ovarian aging, which naturally affects female fertility. As the ovaries age, they produce fewer eggs and hormones, leading to menopause and related health issues. Currently, there is no effective treatment to fully restore ovarian function.

Stem cells have shown promise in treating premature ovarian aging, so researchers investigated whether these treatments could benefit naturally aging ovaries. In the study, they transplanted M-cells—stem cells derived from human embryonic cells with strong immune and anti-inflammatory properties—into the ovaries of aging crab-eating macaques, a type of monkey with a reproductive aging pattern similar to humans.

The results were promising. The treated monkeys showed improved hormone levels, more active ovarian follicles, reduced ovarian fibrosis, and even healthier overall reproductive functions. One monkey even conceived and gave birth, highlighting the treatment’s potential.

With the average age of first-time mothers rising—27 in the United States, nearly 29 in Australia, and over 32 in South Korea—more women are experiencing fertility challenges as ovarian function begins to decline around their late 30s to mid-40s. In China, where the average age for first-time mothers is now over 27, regions like Shanghai see averages above 30.

Current treatments, like hormone replacement therapy, can help ease menopausal symptoms but carry risks such as heart disease, stroke, and breast cancer. Researchers aim to find safer, more effective treatments, especially given that ovarian aging can lead to serious conditions, including osteoporosis, cardiovascular disease, and neurodegenerative disorders.

The study also examined ovarian tissue samples from Chinese women in various age ranges. Findings showed a sharp decline in primordial follicle reserves by age 40, with reserves nearly exhausted by early 50s. But these remaining follicles could still potentially grow, supporting the idea of extending reproductive lifespan.

M-cell transplantation could be a safer and more effective approach to delay ovarian aging, as none of the treated monkeys showed signs of inflammation or other serious side effects. In comparison to untreated monkeys, the transplanted group showed improved hormone levels, follicle development, reduced fibrosis, and lower DNA damage.

The research team concluded that “M-cell transplantation is a feasible clinical strategy to alleviate physiological ovarian aging and extend fertility lifespan,” offering a new direction in fertility treatment that could improve quality of life for many women.

Source

Full Video

The post Chinese Scientists Discover Stem Cell Treatment to Combat Ovarian Aging appeared first on Journos News - Breaking News, World News, Top Stories, Todays Headlines and Flash Reports.