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Headaches are a common symptom of a stressful lifestyle, your body not feeling well and other issues. While headaches can be dealt with easily, migraines are not so easy to handle. Migraines are a type of headache that feels like severe throbbing and pulsing sensation, almost like you are hearing your own heartbeat in your brain, usually on one side of the brain. Many people believe that migraines are not that big of a deal because you just have to deal with the pain, but that is not all migraine is, some people find it very difficult to do their daily tasks as they experience dizzying spells, nausea and extreme sensitivity to light and sound! These attacks can last hours and make it difficult for people to go about their daily lives as well. While there are medications available for migraine patients, these medications need time to take effect, so you may be in a lot of pain, but there are not many quick reliefs you can have in place other than learning the symptoms of a migraine attack and taking medication before it happens. But a new approval by the FDA may change this!
The U.S. Food and Drug Administration (FDA) has approved Symbravo, a new medicine to treat acute migraine attacks in adults. This means adults can now use Symbravo to get relief from their migraine symptoms. The FDA's decision was based on the results of three big studies, called Phase 3 trials. These trials involved over 21,000 migraine attacks, so the FDA has a lot of information about how well Symbravo works and how safe it is. The FDA only approves medicines that have been shown to be both safe and effective through a thorough testing process.
"Migraine attacks can happen suddenly and really mess up people's lives. It's estimated that over 39 million people in the U.S. alone get migraines," said Herriot Tabuteau, M.D., CEO of Axsome Therapeutics told US News. This shows how common migraines are and how important it is to have good treatments. "Symbravo gives patients and doctors a new option that can quickly stop a migraine attack, keep it away, and let people get back to their normal activities, all with just one dose." Having a medicine that can give fast and long-lasting relief from migraine pain is a big deal for millions of people. This new treatment is a real step forward in how we treat migraines.
The trials took place in 3 steps, the Momentum trial study focused on people whose migraines had moderate to severe pain. The results showed that a lot more people taking Symbravo felt pain-free two hours after taking the medicine compared to those who took a placebo which is a dummy pill. Even better, many people felt relief for up to 24 and even 48 hours after just one dose. This long-lasting relief is really important for people with migraines because it means they can get back to their normal lives without worrying about the pain coming back. The study also looked at how many people were free from their worst symptom, like sensitivity to light or sound, or nausea. Symbravo worked better than the placebo in this area too.
While the intercept trial looked at people who took Symbravo when their migraine pain was still mild. Even when the pain was just starting, Symbravo was effective. The results were similar to the MOMENTUM trial, with many people getting pain relief and relief from their worst symptoms. Treating migraines early is often better because it can stop the pain from getting really bad.
And lastly the Movement trial which was to see how safe the medication is when people take it regularly. This study followed 706 people who had at least two migraines a month. The most common side effects people experienced were sleepiness and dizziness. While these side effects are important to know about, the study showed that Symbravo is generally safe for people to use on a regular basis.
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With speed, sudden drops and dizzying twists at hundreds of feet in the air, roller coasters are meant to give riders an adrenaline rush and thrill. But a recent incident related to brain bleeding has shed light on the harmful impact of these extreme movements inside the brain.
A recent investigation found discovered that serious brain injuries have been allegedly linked to the X2 roller coaster at Six Flags Magic Mountain in California.
According to CNN, more than 100 people have allegedly suffered brain injuries after riding the attraction over the past two years. Three lawsuits were filed this week against Six Flags.
Two women who rode X2 just six days apart in July suffered severe brain haemorrhages and required emergency surgery. Doctors treating them attributed their injuries to rapid acceleration and deceleration experienced during the ride.
The cases raise the medical question of what happens to the brain when the body is subjected to sudden, powerful changes in speed and direction?
The brain is surrounded by cerebrospinal fluid, which cushions it against everyday movements and minor impacts. However, this protection has its own limits.
When a roller coaster suddenly accelerates, brakes or changes direction, the head and brain may not always necessarily move at exactly the same speed.
The brain can shift, stretch or rotate within the skull, placing strain on delicate blood vessels and nerve fibres. In extreme circumstances, these forces can tear blood vessels and cause bleeding inside the skull.
So it's not necessary that a person needs to hit their head against a hard surface to sustain a traumatic brain injury. Rapid rotational movements alone can sometimes cause significant damage to the brain.
Also read: Popular Organic Applesauce Recalled Due To Mold Toxin: What Is Patulin & How Dangerous It Is
A subdural haematoma is a life threatening brain injury, in which the blood collects between the brain's outer protective covering, called the dura mater, and the brain's surface.
Sudden acceleration and deceleration can tear the veins that connect the brain to its surrounding structures.
As blood accumulates, pressure inside the skull increases. This can compress brain tissue and, in severe cases, require emergency surgery to remove the blood and relieve pressure.
Also read: Beer Is Getting A 'Health Makeover': Do Protein Or Electrolytes Really Make It Healthier?
G-force means the acceleration experienced by the body relative to Earth's gravity. During sharp turns, steep drops and sudden brakes, roller coaster riders experience changing G-forces. However, G-force alone does not determine whether someone will sustain a brain injury.
The speed and direction of head movements, specially rapid rotation, may also contribute to brain bleeds. A small 2017 study found that roller coasters could produce brain movement and strain comparable to mild football headers. However, the researchers did not find evidence of an immediate risk of acute brain injury on the rides studied.
Serious neurological injuries associated with roller coasters are considered to be rare. The Six Flags cases do not establish that an ordinary roller coaster rides will have the same risks as X2.
People with existing vascular abnormalities, previous head injuries or those taking blood-thinning medications may face additional risks.
A headache after a roller coaster ride may seem harmless, but certain symptoms require immediate medical attention.
According to the US Centers for Disease Control and Prevention, warning signs of a traumatic brain injury include worsening headaches, repeated vomiting, confusion, slurred speech, seizures, weakness and loss of consciousness. Symptoms can appear immediately or develop hours later.
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A popular organic applesauce has been recalled in the US after routine testing by the US Food and Drug Administration (FDA) revealed high levels of patulin, a toxin produced by certain molds that can grow on apples.
Wakefern Food Corp. voluntarily recalled select containers of Wholesome Pantry Organic Unsweetened Apple Sauce after the patulin levels were found to exceed food safety limits. No illnesses linked to the toxin have been reported yet.
The recall involves 23-ounce plastic jars with UPC 04119005677 and a best-by date of June 16, 2027. The product was sold through ShopRite, Price Rite Marketplace, The Fresh Grocer, Gourmet Garage and Fairway Market.
Patulin is a mycotoxin, meaning it is a toxic chemical produced by certain species of fungi or mold.
The FDA identifies molds from genera including Penicillium, Aspergillus and Byssochylamys as sources of patulin. Apples are one of the best-known sources, particularly when fruit is bruised, damaged, rotten or improperly stored.
When contaminated apples are used to make products like apple juice or applesauce, the toxin can remain it. The pasteurisation does not eliminate patulin, so simply heating an apple product is not a reliable way to get rid of the toxin.
Also read: Beer Is Getting A 'Health Makeover': Do Protein Or Electrolytes Really Make It Healthier?
The health concern depends on the amount and duration of exposure to patulin. According to the FDA, consuming food or beverages containing high levels of patulin may cause nausea and vomiting, while evidence also indicates that the toxin can damage cells. The agency monitors patulin because prolonged exposure to elevated levels may pose a serious health hazard.
The FDA has established an action level of 50 parts per billion (ppb) for patulin in apple juice, apple juice concentrates and apple juice products.
This does not mean that eating a food once above the regulatory limit automatically causes poisoning. Food safety limits are designed to control exposure and reduce potential health risks, particularly when contamination could occur repeatedly.
Molds formed due to patulin can grow on apples that have been bruised, damaged or allowed to rot. Contamination can also happen during storage.
The problem can be difficult to identify simply by looking at the finished food. FDA guidance notes that some contamination can originate from internal problems like core rot that may not be obvious from the outside of an apple. Removing damaged fruit before processing is therefore an important control measure.
So, anyone who has the recalled Wholesome Pantry Organic Unsweetened Apple Sauce at home should not consume it.
Consumers should check the jar for the 23-ounce size, UPC 04119005677 and best-by date June 16, 2027. The company says recalled products can be returned to the store for a refund or replacement.
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Stopping GLP-1 drugs such as Ozempic, Wegovy, Mounjaro and Zepbound may cause some of their cardiovascular benefits to fade, a large new study suggests.
Researchers from Washington University in St. Louis found that people who stopped GLP-1 treatment had a progressively higher risk of major cardiovascular events, including heart attack, stroke and death. After two years off treatment, their risk was 22% higher than among those who continued taking the drugs.
The findings, published in BMJ Medicine, are significant as GLP-1 drugs are widely used to treat type 2 diabetes and obesity and have also been shown to provide cardiovascular benefits.
Researchers analyzed health data from 333,687 US veterans with type 2 diabetes over up to three years. Of these, 132,551 had been prescribed GLP-1 drugs, while 201,136 had been prescribed sulfonylureas, another class of diabetes medicines.
Treatment status was reassessed every six months. About 26% of GLP-1 users stopped treatment completely, while another 23% had a treatment gap of at least six months before restarting.
The longer people remained off treatment, the greater their cardiovascular risk.
After one year without restarting, the risk of major cardiovascular events was 14% higher than among continuous users. After two years, it was 22% higher.
"There is enormous exuberance about starting GLP-1 drugs, but not nearly enough attention to what happens when people stop," said senior author Ziyad Al-Aly, a clinical epidemiologist at Washington University.
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People who remained on GLP-1 drugs throughout the three-year study had an 18% lower risk of major cardiovascular events than those taking sulfonylureas.
That translated to about four fewer major cardiovascular events per 100 people over three years.
Those who remained on treatment for two or 2.5 years before stopping also had lower cardiovascular risk, by 7% and 15%, respectively.
However, people who stopped before 18 months did not have a significant reduction in cardiovascular risk compared with those taking sulfonylureas by the end of the study.
Interrupting GLP-1 treatment and later restarting it was associated with less cardiovascular protection. While continuous users had an 18% reduction in major cardiovascular events, those who stopped and later restarted had an average 12% reduction.
Even a six-month treatment gap was associated with a 4% to 8% increase in cardiovascular risk compared with continuous use.
Al-Aly said many patients stop GLP-1 drugs because of "cost, side effects or shortages."
"When they stop, it's not just weight that comes back; they experience a resurgence in inflammation, blood pressure, and cholesterol. Weight regain is visible; the metabolic reversal is not," he said.
"Our data suggest this metabolic whiplash is detrimental to heart health," Al-Aly added.
Read More: EXCLUSIVE: GLP-1 Drugs Are The ‘New Statins’, Says University Hospital Birmingham Professor
Restarting treatment appeared to restore some cardiovascular protection, but not all of it.
The researchers said the findings suggest that cardiovascular benefits gained during GLP-1 treatment may diminish after treatment is interrupted.
"Clinicians should treat adherence to GLP-1 treatment as an important outcome in its own right -- not an afterthought," Al-Aly said.
He added that healthcare systems should help patients manage side effects, address cost barriers and understand that GLP-1 drugs are used to manage chronic conditions.
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