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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 sold as Veozah, is the first drug to target neurons in the brain that become out of balance 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,” the doctor said. 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.

TueWe live in a toxic food environment and Big Food employs extremely smart marketers and food scientists. The fact that we all eat a lot of Big Food products means that these people are very good at their job. This does not mean that we have failed if we eat what the industry produces.

In the UK, about 50% of the average adult’s diet and 65% of the child’s diet contain ultra-processed foods. Like Dr. Chris Van Tulleken’s latest book, Ultra-processed people: why are we all eating things that aren’t food… and why can’t we stop?this means that most of what we eat includes newly invented substances that people have not eaten before, and we know very little about how they interact with us or with each other.

Such products are likely to be made by companies such as Unilever, PepsiCo or Nestlé. UK food industry spends £1.14bn a year on advertising and as a former Big Food marketer Dan Parker notedit uses manipulative tactics such as associating foods such as chocolate with positive things such as relaxation (KitKats, Maltesers) or emotional openness (Cadbury’s “Give A Doubt”) while normalizing overconsumption through advertising showing one – always small – person eating chocolate. family bar (think Audrey Hepburn in a Galaxy ad).

Criticizing over processed foods (UPFs) does not necessarily mean shaming those who eat them. But we are shaming and blaming people who eat UPF, including ourselves often, and this must stop. (We also have a nasty habit of demonizing foods that are important to certain cultures, such as fried chicken.) Shame is never motivating, and what we eat is not a symbol of morality. While almost all of us eat a lot of UPF, we tend to think of it as a problem that mostly affects people living in poverty. It is completely unconstructive to vilify the diets of people already living in highly stressful situations. But it’s also a mistake to assume that it doesn’t apply to “us,” whatever your socioeconomic background may be.

UPFs are hiding in plain sight. Definitions vary, but they are mostly packaged and made with preservatives, stabilizers, emulsifiers, colors or flavor enhancers. They include everyday foods such as store-bought hummus, stuffed pasta, hot sauce, curry paste, ready meals, some jams, most peanut butters, most breads, vegan meat alternatives, almost all grains, most sausages. products, hamburgers and sausages, soft foods. beverages, sweetened or low-fat yogurt, many sugar-free products, dairy substitutes, and almost all ice cream, desserts, chips, crackers, and cookies in the supermarket. If your cart doesn’t have a fair amount of that list, then there are several options: you have a superhuman level of willpower; you are very wealthy and/or have your own chef from scratch; you’re lying

Many UPFs are cheap, but ones that don’t often have a healthy halo, like plant-based meat alternatives, cereal bars, or protein powders. In fact, consumption of UPFs of all types is associated with an increased risk of all sorts of health problems, including various types of cancer and weight gain.

UPFs are very comfortable and heavily advertised as a way to make our hectic lives easier. Therefore, those who criticize the UPF are often perceived as dealing with people who already feel jaded by the way we have organized society.

But the problem is not with us. The problem is structural. Organizing a society so that people don’t feel like they have enough time or money to cook their own food is a dystopian nightmare. Selling us cheap food that can harm us but is presented as healthy or healthy is a dystopian nightmare. And as Henry Dimbleby points out in his new book, Insatiableso does urban planning, which means more than three million people cannot access stores selling fresh produce.

Our hysterical fear of being overweight has led us to individualize responsibility for what we eat without taking into account the very subtle relationship between body size and health. Despite 59 types of obesity been identified, the British (conspicuously unsuccessful) approach to weight management continues to be variations on the “eat less, exercise more” theme, as well as the new and highly publicized semaglutide weight loss drugs, Ozempic and Wegovy (originally created to treat diabetes). ), O who come out of economist To NY the magazine gushed out (often containing an unnecessary line about stomach side effects and associated risk of pancreatitis and possibly cancer).

They are trying to solve the wrong problem: we should not live in a food environment where a significant number of people need (or want) to take drugs to cope.

UPF’s popularity is a symptom of something much bigger, not just that Big Food is good at marketing and producing irresistible, high-calorie foods. We are talking about the primacy of work, long working hours, low pay, a culture of hustle and bustle, structural inequality, poverty and instability. For most of us it is almost impossible to choose the so-called “good” food.

Especially it concerns if you are stressedexhausted or labor in any conditions of scarcity or insecurity, all of which were shown in many studies affect not only our choice of food but How does our body digest food?. And who, to one degree or another, does not feel the pressure of life in permanent crisis Britain?

The solution to the problem is not to change the formulations by the manufacturers (although this may help). It’s much more difficult. Our food problems are just symptoms of other social problems, so it’s ridiculous to pretend that each of us can solve them on our own. If there’s a moral question that needs to be answered, it’s who makes UPFs, not who eats them.

Every time we make a particular body – ours or someone else’s – a platform for talking about “good” and “bad” food preferences, weight or figure, we are looking at the problem upside down. We turn our food choices into a moral maze instead of saying: this is food that is broken and needs to be changed. Not to us.