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FDA on Friday approved the first non-hormonal drug for the treatment of hot flashes in menopausal women, offering a potential remedy for symptoms of upper body overheating and sweating that can interfere with daily life for many years.

The drug, which will be marketed as Veozah, is the first to target neurons in the brain that become imbalanced when estrogen levels drop. According to Marcy English, vice president of Astellas Pharma, the drug’s maker, it’s usually given to women in their 50s during the menopausal phase, which is estimated to last seven years.

The agency said the drug was approved for moderate to severe symptoms.

Why it matters: There are several harmless antidotes.

Periodic overheating is a common symptom of menopause, which Astellas suggests affects at least 60 percent of women.

“Hot flashes as a result of menopause can be a serious physical burden for women and affect their quality of life,” says the doctor. Janet Maynard, FDA Center for Drug Evaluation and Research.

They can be long lasting and interfere with basic functions of daily life.

Hormonal drugs, including estrogen and progestin, were associated with an increased risk of blood clots and stroke decades ago, but further research has shown that the risk is much lower in women in their 40s and 50s.

Background: symptoms long gone

Hot flashes are the most common side effect of menopause for which women typically seek treatment, Astellas says.

And the complaints of those who experience hot flashes and other menopausal symptoms are often ignored in the workplace and elsewhere.

“It’s distracting,” Miss English said. “It is not comfortable. It’s something we sort of dealt with silently.”

The drug was found to be effective and generally safe in year-long studies, with side effects including abdominal pain, diarrhea, and insomnia, according to the FDA.

Because some patients showed signs of liver damage while studying the drug, the FDA said patients should have a blood test before starting the drug to check for existing liver problems, and then repeat the tests for the first nine months of taking the drug.

“Patients experiencing symptoms associated with liver damage, such as nausea, vomiting, or yellowing of the skin and eyes, should see a doctor,” FDA says. statement says.

What’s next: The price of the drug could be prohibitive

Astellas said the drug will cost $550 for a 30-day supply, not including rebates. The company said it would launch a support program “to help patients access the medications they’ve been prescribed.” The Institute for Clinical and Economic Review recommended a reduction in the price from $2,000 to $2,600 per year.

Ms English said Astellas was ready to have the drug in pharmacies within three weeks of approval.

DEAR MAYO CLINIC! As I get older, I find that I have more and more trouble sleeping. I struggled to fall asleep and then stay asleep. I wake up at night and get upset when I see the clock. By the time I fall asleep again, my alarm clock is set to wake me up. I feel overwhelmed during the day and actively look for opportunities to take a nap. It would be great to wake up rested and ready for a new day. What can I do to improve my sleep?

REPLY: You are not alone if you have trouble falling or staying asleep. Many people struggle with sleep – and this is a problem, as sleep plays a critical role in your health, energy levels, and ability to function at your best. Most adults need between seven and eight hours of sleep every night to feel well rested and energized every day.

If restless nights have become the norm for you, or if you find that sleep does not refresh you, start by monitoring your sleep patterns. Make notes about how much sleep you get each night, what factors affect your sleep, how rested you feel the next morning, and how sleepy you feel during the day.

After observing your sleep pattern for at least one, preferably two weeks, try the following five strategies to help improve your sleep:

1. Minimize light and sound. These two environmental factors can affect the quality and quantity of sleep. Darkness causes your brain to release melatonin for a calming and sleepy effect. As a result, it is important to minimize exposure to light before bed. Even the light from your computer, TV, or other devices can make it difficult to fall asleep. Ban these devices from your bedroom and create a dark space by using blackout curtains or an eye mask. Noise can also interfere with your sleep. Try using a fan or noise generator to block out unwanted noise.

2. Get comfortable. Adults spend about a third of their lives sleeping, so it’s worth investing in bedding that soothes and relaxes you. Don’t forget the pillows too. Before going to bed, try lowering the temperature a few degrees. Your core temperature drops when you rest, and keeping your room cool will help this natural temperature drop.

3. Follow the regime. As childrenAdults sleep better when they have a sleep routine. Stick to a regular sleep schedule. Try to go to bed and wake up at the same time on both weekdays and weekends. By doing the same thing before bed every night, you will prepare your body for rest and prepare your brain for sleep. Engage in activities that promote relaxation, such as light stretching, journaling, reading, or meditation.

4. Manage stress. How are you to handle the stress can significantly affect your ability to fall asleep and stay asleep. While stress isn’t all that bad, it can disrupt your sleep when it escalates into restlessness or anxiety. If your busy mind keeps you awake at night, try practicing stress management techniques before bed. By listening to, but not watching, sleep talking meditation, you can clear your mind before bed. Experiment with aromatherapy, deep breathing, thank you magazine or meditation.

5. Get out of bed. If you’re lying in bed worrying about not being able to sleep, get out of bed and do something to help you relax. It may be reading an uninteresting book, an activity relaxation technique or focus on your breathing. When you feel sleepy, go back to bed. Try not to spend time in bed upset about sleep.

Make sleep a priority. Even if you’re already a sound sleeper, these tips can help.

If you’re still not getting enough sleep, use these additional tips until you get enough sleep to feel better every day:

• Keep a written journal of your sleep schedule this week.
• Turn off your electronic devices – including your phone and TV – an hour before bed every night.
• Do a few light stretches before bed to help you unwind.

Keep making adjustments until restless nights are a thing of the past. If, despite these measures, you are struggling with sleep, it may be time to talk to your healthcare provider. — Rachel ZieglerMD, Pulmonology and Critical Care Medicine, Mayo Clinic Health System, Fairmont another mankatoMinnesota

(Q&A at the Mayo Clinic is an educational resource and does not replace your regular medical care. Email your question MayoClinicQ&A@mayo.edu. For more information visit www.mayoclinic.org.)

©2023 Mayo Foundation for Medical Education and Research. All rights reserved. Distributed by Tribune Content Agency, LLC.

The official report said that welfare officials failed to properly assess the risk of harm to Errol Graham, a severely mentally ill man for whom they withheld disability benefits and who starved to death eight months later.

IN independent security review in the “shocking and disturbing” events leading up to Graham’s tragic and lonely death, concluded that the multiple failures of the Department of Work and Pensions (DWP), his general practice practice, and the social landlord meant that the chance to save him was lost.

Describing Graham as “an acutely mentally disturbed man who has shut himself off from the world”, the Nottingham City Adult Welfare Council said that the decisions made by all three agencies exacerbated his problems towards the end of his life, rather than sustained him.

A few months before his death, his disability benefits were halted, resulting in the automatic cancellation of his housing allowance, leaving him £1,000 in rent arrears. It also led to the shutdown of his gas supply and attempts to evict him.

The emaciated body of 57-year-old Graham was found by bailiffs who broke down the door of his Nottingham home to evict him in June 2018. expired cans of fish.

The review, which refers to Graham as “Billy,” states: “There were a number of missed opportunities for information sharing between services. If the information were passed on, it could reveal the true nature of Billy’s mental health anguish and mobilize the care and treatment he needed.”

Graham, a grandfather and former amateur football player with a long history of mental illness, lost contact with his family and support services in the latter stages of his life as his well-being deteriorated and he became withdrawn and socially isolated.

The review said that DWP and Nottingham City Homes were unable to understand why Graham did not respond to their letters, text messages and home visits and therefore failed to grasp the extent of his vulnerability when they left him without money, food and on the brink of homelessness. .

While both agencies correctly followed their own procedures when they made important decisions to deny Graham vital services, the review makes it clear that such procedures were based on “partial information and misconceptions” about why Graham refused to cooperate with them.

The review featured a poignant note left by Graham and found in his apartment after his death, in which he eloquently describes the fear, anxiety and pain caused by his depression. “All I want in life is to live normally. This would be the answer to my prayers,” he wrote.

The review makes it clear that while Graham exhibited “self-neglecting behavior” and effectively cut off all contact with the services, “the latest detrimental impact on his well-being was caused by the response of agencies to cut off access to those basic physical needs that were essential to his life.”

It says that the main lesson from Graham’s death was that his refusal to interact with support services did not deny his vulnerabilities and was not an excuse for inaction on the part of service providers. “Indeed, refusal to participate can be a sign of increased vulnerability,” he concluded.

Alison Burton, Graham’s sister-in-law, told the Guardian she welcomes many aspects of the report, in particular how it points out how shortcomings in services have left Graham despondent. But she said that the DWP should take on a legal obligation to be careful that vulnerable applicants do not slip out of the social protection system.

Nottingham City Adult Advocacy Council Chair Leslie Hutchinson said: “This review looked at the shocking circumstances of a man’s death where agency intervention exacerbated his problems rather than providing support. My sincere condolences to all who knew and loved [Errol]”.

The City of Nottingham Housing Authority (formerly Nottingham City Homes), GP practice and DWP said in the report that they have taken steps to improve information sharing and better safeguards for vulnerable applicants.

An investigation into the case in 2019 found that there were “holes” in the security around Graham. A subsequent judicial review initiated by Graham’s family, which tried to prove that the DWP had acted illegally by failing to protect him, was unsuccessful.

A DWP spokesperson said the review acknowledged the significant improvements made to processes since Graham’s death. They added: “It was an incredibly tragic case and we send our condolences to the family.”