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Greater weight loss promised by higher-dose Wegovy shot, now approved by FDA

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Greater weight loss promised by higher-dose Wegovy shot, now approved by FDA

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The U.S. Food and Drug Administration announced on Thursday its approval of a new, higher-dose Wegovy (semaglutide) injection.

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The 7.2 mg dosage, called Wegovy HD, is intended for weight loss and long-term weight loss maintenance for adult patients. It is triple the previous maximum dose of 2.4 mg.

This marks the fourth approval in the FDA’s National Priority Voucher pilot program, which “seeks to expedite approval of applications that address critical national health priorities,” according to FDA Commissioner Dr. Martin Makary.

NEW WEGOVY PILL OFFERS NEEDLE-FREE WEIGHT LOSS – BUT MAY NOT WORK FOR EVERYONE

“The new FDA is moving with unprecedented efficiency on products that advance national priorities,” he said in a press release. “Today’s approval is another demonstration of what the FDA can accomplish when we try bold new things.”

The U.S. Food and Drug Administration announced on Thursday its approval of a new, higher-dose Wegovy (semaglutide) injection. (Michael Siluk/UCG/Universal Images Group via Getty Images)

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The higher-dose GLP-1 is indicated to “reduce excess body weight and maintain weight reduction long-term in adults with obesity, or overweight with at least one weight-related condition,” per the FDA’s statement.

STOPPING GLP-1 DRUGS LIKE OZEMPIC ERODES HEART HEALTH BENEFITS QUICKLY, NEW STUDY FINDS

“The approval of a new higher dose will provide adult patients with an additional therapeutic option, offering the potential for greater weight loss,” the agency stated.

The FDA’s approval, granted to drugmaker Novo Nordisk, was supported by clinical data that found higher doses resulted in additional average weight reduction compared to previous dosing. 

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Higher-dose patients with both obesity and type 2 diabetes saw similar lowering of blood sugar compared to the lower dose, the agency noted.

The safety profile is consistent with the known side effects of semaglutide, which commonly include gastrointestinal reactions like nausea, vomiting, diarrhea, constipation and abdominal pain.

Wegovy HD (7.2 mg) is triple the dosage compared to the previous maximum dose of 2.4 mg. (Steve Christo – Corbis/Corbis via Getty Images)

Skin sensitivity, pain or burning occurred more frequently with higher doses of Wegovy, but generally resolved on their own or with dose reduction, the FDA reported. The agency is investigating these adverse effects.

The FDA warned that Wegovy should not be used by patients with a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer) or who have multiple endocrine neoplasia syndrome type 2 (a rare inherited genetic disorder that causes tumors to develop in certain hormone-producing glands). All patients should see a doctor for guidance on proper use.

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Jamey Millar, executive vice president of U.S. operations for Novo Nordisk, commented on this approval in a press release.

“We are excited to bring Wegovy HD injection to adults with obesity who are looking for powerful weight loss, as no other weight-loss medicine has been studied to show superiority to Wegovy HD,” he said. 

Millar also noted that Wegovy has been shown to reduce the risk of events such as stroke, heart attack or cardiovascular death in those who also have known heart disease.

A weight-loss expert warned that Wegovy HD should be used only for obesity management. (iStock)

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Dr. Peter Balazs, a hormone and weight-loss specialist practicing in New York and New Jersey, reflected on results of the STEP UP clinical trial, on which the drug’s approval was based.

Patients taking the higher dose experienced an average weight loss of 20.7% compared to about 16% on the standard dose, the doctor noted. About one-third lost 25% or more of their body weight.

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“For patients who start on 2.4 mg and then hit a frustrating plateau, or for those with a very high baseline BMI who may need a stronger metabolic push, this creates a legitimate, evidence-based escalation path rather than forcing an early switch to another drug class,” Balazs, who was not involved in the study, told Fox News Digital.

“That said, I think this is an interesting approval, but I do not expect it to dramatically reshape the GLP-1 landscape,” he went on. “It gives Novo Nordisk an opportunity to remain competitive on efficacy while it continues developing next-generation therapies.”

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“This creates a legitimate, evidence-based escalation path.”

“Other drugs have already shown greater efficacy in prior studies, and the broader GLP-1 space is likely to see much more significant change as new molecules enter the market.”

Balazs called the higher dosage a “major jump,” noting that the incidences of stomach- and skin-related side effects at this higher dose are “meaningful.”

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“This approval is for obesity management, not diabetes treatment,” the expert emphasized. “For patients with type 2 diabetes, currently approved semaglutide dosing remains lower unless the primary treatment goal is weight loss under the obesity indication.”

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Fox News Digital reached out to the FDA for comment.

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Dementia risk signals could lie in simple blood pressure readings, researchers say

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Dementia risk signals could lie in simple blood pressure readings, researchers say

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Simple measurements taken during routine blood pressure checks could predict dementia risk years before symptoms appear.

That’s according to new research presented this week at the American College of Cardiology’s Annual Scientific Session in Louisiana.

The findings draw on two studies led by researchers at Georgetown University, which suggest that monitoring how blood vessels age and stiffen over time can provide a window into future cognitive health.

LURKING DEMENTIA RISK EXPOSED BY BREAKTHROUGH TEST 25 YEARS BEFORE SYMPTOMS

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Data shows rates of dementia and aging-related cognitive decline are expected to increase as populations age, and half of U.S. adults have high blood pressure (hypertension).

Scientists believe that efforts to better address hypertension, a key contributor to heart disease and a risk factor for dementia, could affect both cardiac and brain health.

Data shows rates of dementia and aging-related cognitive decline are expected to increase as populations age. Meanwhile, half of U.S. adults have high blood pressure. (iStock)

“Blood pressure management isn’t just about preventing heart attacks and strokes; it may also be one of the most actionable strategies for preserving cognitive health,” Dr. Newton Nyirenda, the study’s lead author and an epidemiologist at Georgetown University in Washington, said in a press release.

The research focused on two metrics, the pulse pressure-heart rate index and estimated pulse wave velocity. Both were calculated using data collected during standard doctor visits, such as heart rate, age and blood pressure.

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“Blood pressure management isn’t just about preventing heart attacks and strokes; it may also be one of the most actionable strategies for preserving cognitive health.”

Researchers examined five years of data patterns for more than 8,500 people in the SPRINT trial, a large study of adults 50 years and older with hypertension. In the follow-up, 323 of the participants developed probable dementia.

HIDDEN BRAIN CONDITION MAY QUADRUPLE DEMENTIA RISK IN OLDER ADULTS, STUDY SUGGESTS

In one study, the team found the pulse pressure-heart rate index was a strong independent predictor of dementia risk in adults over 50. For participants under 65, every one-unit increase was associated with a 76% higher risk of developing dementia.

For participants under 65, an increase in the pulse pressure-heart rate index was associated with a 76% higher risk of developing dementia. (iStock)

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The second study found that adults with consistently elevated or rapidly increasing pulse wave velocity were more likely to develop dementia than those with stable velocity, even after accounting for factors like smoking, gender and cardiovascular history.

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“Our findings suggest that vascular aging patterns may provide meaningful insight into future dementia risk,” said Nyirenda. “This reinforces the idea that managing vascular health earlier in life may influence long-term brain health.”

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The team emphasized that clinicians should tailor risk assessments and treatment strategies to the individual.

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Further studies are needed to confirm these parameters and determine whether changing vascular aging trajectories reduces dementia risk. (iStock)

“You don’t want to wait until a patient starts manifesting cognitive decline before you act,” said senior study author Sula Mazimba, an associate professor at the University of Virginia.

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Researchers noted the study could not establish causation. Other limitations included the fact that participants already had hypertension and elevated cardiovascular risk, meaning the findings may not apply to people without those conditions.

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Further studies are needed to confirm these findings and to determine whether improving blood vessel health over time could reduce dementia risk.

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Everything You Need To Know About Zepbound for Weight Loss, Including Costs

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Everything You Need To Know About Zepbound for Weight Loss, Including Costs


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What Is Zepbound? Weight-Loss Benefits, Costs and Dosage




















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‘Gas station heroin’ banned in another state amid nationwide crackdowns

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‘Gas station heroin’ banned in another state amid nationwide crackdowns

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A dangerous substance dubbed “gas station heroin” continues to alarm medical professionals, with more states making moves to restrict or ban tianeptine.

Fourteen states have officially classified the tricyclic antidepressant as a Schedule I controlled substance.

Connecticut is the latest state to crack down, officially banning the sale and use of the substance starting on Wednesday.

HEALTH OFFICIALS WARN OF DANGEROUS SUBSTANCE AVAILABLE IN STORES ACROSS THE NATION

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Tianeptine, which can produce euphoria in higher doses, can be more potent than morphine and addictive opioids, according to the U.S. Food and Drug Administration.

Some countries have taken steps to restrict how tianeptine is prescribed or dispensed, and have even revised the labels to warn people of its potential addictive qualities.

Tianeptine can be more potent than morphine and addictive opioids. (iStock)

Misuse of tianeptine can cause severe adverse health effects, including respiratory depression, severe sedation and death, according to the Drug Enforcement Administration.

Some companies market the drug as an aid for pain, anxiety and depression, or as a means of improving mental alertness in a pill, powder, salt or liquid form.

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The products are typically sold at convenience stores, gas stations, vape shops and online retailers, and go by names like Tianaa, ZaZa, Neptune’s Fix, Pegasus and TD Red.

Connecticut is the 15th state to classify tianeptine as a Schedule I controlled substance. (Markus Scholz/picture alliance via Getty Images)

Connecticut Lt. Gov. Susan Bysiewicz said in a press release that the schedule change is a necessary step to combat addiction.

“With false marketing that led consumers to believe these are safe products, and with candy-like flavor options, these substances posed a clear threat to those battling substance-use disorder and our youngest residents,” she added.

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The Nutmeg State also added Mitragyna speciosa (kratom), 7-hydroxymitragynine, Bromazolam, Flubromazolam, Nitazenes and Phenibut to the schedule classification.

Earlier this month, FDA Commissioner Martin Makary penned a letter sounding the alarm on what he called a “dangerous and growing health trend.”

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“I am very concerned,” Makary wrote. “I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America’s youth.”

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New York-based Robert Schwaner, M.D., vice chair of system clinical affairs at Stony Brook Emergency Medicine, told Fox News Digital that the FDA has never approved tianeptine as a dietary supplement.

“As with heroin and other opioids, significant mu-opioid receptor stimulation ultimately results in a loss of respiratory drive and subsequent cardiac arrest.” (Dekalb County Sheriff’s Office)

“The euphoria at low doses is primarily due to increased serotonergic activity from its serotonin reuptake effects. With increasing doses, the mu-opioid receptor stimulation may become lethal,” said Schwaner. “As with heroin and other opioids, significant mu-opioid receptor stimulation ultimately results in a loss of respiratory drive and subsequent cardiac arrest.”

Schwaner said he believes the substance requires national regulation due to its addictive qualities. 

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“Acting at the same receptor as opioids, tianeptine has the potential for an individual to develop tolerance, subsequent dependence and withdrawal from its use,” he cautioned.

Fox News Digital reached out to the FDA for comment. 

Fox News Digital’s Greg Wehner and Melissa Rudy contributed to this report.

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