Health

F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia

Published

1 year ago

February 26, 2025

F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia

The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.

The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.

Clozapine, which was approved in 1989, is regarded by many physicians as the most effective available treatment for schizophrenia, and research shows that the drug significantly reduces suicidal behavior. Clozapine is also associated with a rare side effect called neutropenia, a drop in white blood cell counts that, in its most severe form, can be life-threatening.

In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.

Physicians have long complained that, as a result, clozapine is grossly underutilized.

Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.

“I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”

The F.D.A.’s shift came after years of lobbying by pharmacists, clinicians and relatives of people with schizophrenia, who cataloged the cases of patients who deteriorated after losing access to clozapine.

“There were patients who ended up relapsing into psychosis, patients who ended up hospitalized, patients who became violent,” said Raymond C. Love, a professor emeritus at the University of Maryland School of Pharmacy, who helped organize the effort.

When an advisory committee to the F.D.A. reviewed the requirement at a meeting in November, he said, the agency had to expand the public docket to accommodate the number of people who wanted to speak.

“That was how much the outcry was,” he said. “There were people in tears.”

In a statement published on its website on Monday, the F.D.A. said it had determined that the testing regimen was “no longer necessary to ensure that the benefits of the medicine outweigh” the risk of severe neutropenia. Its prevalence is estimated at around 0.9 percent worldwide and decreases after the first six months of treatment.

But Dr. John M. Kane, a leading schizophrenia researcher, said he did not expect a substantial shift in prescribing as a result of the change. Even without the testing regimen, he said, many physicians are hesitant to prescribe clozapine because it requires close monitoring during the early months of treatment.

“Probably 1 in 8 patients in the U.S. who might benefit from clozapine are getting it,” said Dr. Kane, a professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell. For a portion of them, he said, the medication is “life-changing.”

Psychotic disorders like schizophrenia affect 1 percent to 3 percent of the adult population, but the disease is a crushing burden to society. The illness typically emerges in late adolescence and is characterized by psychotic symptoms, like hallucinations or delusions, as well as by social withdrawal, cognitive impairment and a lack of motivation.

Studies suggest that the risk of suicide for people with schizophrenia is at least 10 times as high as that for the general population.

Though many people manage their symptoms with the help of their families, others cycle through incarcerations, homelessness and brief hospitalizations. A 2022 analysis of the economic burden associated with the disease published in The Journal of Clinical Psychiatry estimated the yearly cost at $343.2 billion, largely from caregiving, premature mortality and unemployment.

The first antipsychotic medication, chlorpromazine, became available 70 years ago, and was followed by two waves of new treatments designed to alter dopamine pathways in the brain. But the pace of discovery slowed after that, as vast sums of research funding were devoted to investigating the genetics of the disease. Last September, the F.D.A. approved Cobenfy, the first novel antipsychotic treatment in decades.

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Health

Heart disease threat projected to climb sharply for key demographic

Published

2 hours ago

February 27, 2026

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Heart disease threat projected to climb sharply for key demographic

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A new report by the American Heart Association (AHA) included some troubling predictions for the future of women’s health.

The forecast, published in the journal Circulation on Wednesday, projected increases in various comorbidities in American females by 2050.

More than 59% of women were predicted to have high blood pressure, up from less than 49% currently.

The review also projected that more than 25% of women will have diabetes, compared to about 15% today, and more than 61% will have obesity, compared to 44% currently.

As a result of these risk factors, the prevalence of cardiovascular disease and stroke is expected to rise to 14.4% from 10.7%.

The prevalence of cardiovascular disease and stroke in women is expected to rise to 14.4% from 10.7% by 2050. (iStock)

Not all trends were negative, as unhealthy cholesterol prevalence is expected to drop to about 22% from more than 42% today, the report stated.

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Dr. Elizabeth Klodas, a cardiologist and founder of Step One Foods in Minnesota, commented on these “jarring findings.”

“The fact that on our current trajectory, cardiometabolic disease is projected to explode in women within one generation should be a huge wake-up call,” she told Fox News Digital.

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“Hypertension, diabetes, obesity — these are all major risk factors for heart disease, and we are already seeing what those risks are driving. Heart disease is the No. 1 killer of women, eclipsing all other causes of death, including breast cancer.”

Cardiovascular disease is the leading cause of death for women in the U.S. and around the world. (iStock)

Klodas warned that heart disease starts early, progresses “stealthily,” and can present “out of the blue in devastating ways.”

The AHA published another study on Thursday revealing one million hospitalizations, showing that heart attack deaths are climbing among adults below the age of 55.

The more alarming finding, according to Klodas, is that young women were found more likely to die after their first heart attack than men of the same age.

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“This is all especially tragic since heart disease is almost entirely preventable,” she said. “The earlier you start, the better.”

Children can show early evidence of plaque deposition in their arteries, which can be reversed through lifestyle changes if “undertaken early enough and aggressively enough,” according to the expert.

Moving more is one part of protecting a healthy heart, according to experts. (iStock)

Klodas suggested that rising heart conditions are associated with traditional risk factors, like smoking, high blood pressure, high cholesterol, diabetes, obesity and a sedentary lifestyle.

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Doctors are also seeing higher rates of preeclampsia, or high blood pressure during pregnancy, as well as gestational diabetes. Klodas noted that these are sex-specific risk factors that don’t typically contribute to complications until after menopause.

The best way to protect a healthy heart is to “do the basics,” Klodas recommended, including the following lifestyle habits.

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Klodas especially emphasized making improvements to diet, as the food people eat affects “every single risk factor that the AHA’s report highlights.”

“High blood pressure, high blood sugar, high cholesterol, excess weight – these are all conditions that are driven in part or in whole by food,” she said. “We eat multiple times every single day, which means what we eat has profound cumulative effects over time.”

“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health,” a doctor said. (iStock)

“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health.”

The doctor also recommends changing out a few snacks per day for healthier choices, which has been proven to “yield medication-level cholesterol reductions” in a month.

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“Keep up that small change and, over the course of a year, you could also lose 20 pounds and reduce your sodium intake enough to avoid blood pressure-lowering medications,” Klodas added.

“Women should not view the AHA report as inevitable. We have power over our health destinies. We just need to use it.”

Angelica Stabile is a lifestyle reporter for Fox News Digital.

Health

Vanessa Williams, 62, Opens up About Weight Loss and HRT After Menopause

Published

13 hours ago

February 26, 2026

Press Room

Vanessa Williams, 62, Opens up About Weight Loss and HRT After Menopause

Vanessa Williams Opens up About Weight Loss and HRT | Woman’s World

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Health

Common vision issue linked to type of lighting used in Americans’ homes

Published

14 hours ago

February 26, 2026

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Common vision issue linked to type of lighting used in Americans’ homes

NEWYou can now listen to Fox News articles!

Nearsightedness (myopia) is skyrocketing globally, with nearly half of the world’s population expected to be myopic by 2050, according to the World Health Organization.

Heavy use of smartphones and other devices is associated with an 80% higher risk of myopia when combined with excessive computer use, but a new study suggests that dim indoor lighting could also be a factor.

For years, scientists have been puzzled by the different ways myopia is triggered. In lab settings, it can be induced by blurring vision or using different lenses. Conversely, it can be slowed by something as simple as spending time outdoors, research suggests.

Nearsightedness occurs when the eyeball grows too long from front to back, according to the American Optometric Association (AOA). This physical elongation causes light to focus in front of the retina rather than directly on it, making distant objects appear blurry.

The study suggests that myopia isn’t caused by the digital devices themselves, but by the low-light environments where they are typically used. (iStock)

Researchers at the State University of New York (SUNY) College of Optometry identified a potential specific trigger for this growth. When someone looks at a phone or a book up close, the pupil naturally constricts.

COMMON VISION ISSUE COULD LEAD TO MISSED CANCER WARNING, STUDY FINDS

“In bright outdoor light, the pupil constricts to protect the eye while still allowing ample light to reach the retina,” Urusha Maharjan, a SUNY Optometry doctoral student who conducted the study, said in a press release.

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“When people focus on close objects indoors, such as phones, tablets or books, the pupil can also constrict — not because of brightness, but to sharpen the image,” she went on. “In dim lighting, this combination may significantly reduce retinal illumination.”

High-intensity natural light prevents myopia because it provides enough retinal stimulation to override the “stop growing” signal, even when pupils are constricted. (iStock)

The hypothesis suggests that when the retina is deprived of light during extended close-up work, it sends a signal for the eye to grow.

In a dim environment, the narrowed pupil allows so little light through that the retinal activity isn’t strong enough to signal the eye to stop growing, the researchers found.

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In contrast, being outdoors provides light levels much brighter than indoors. This ensures that even when the pupil narrows to focus on a nearby object, the retina still receives a strong signal, maintaining healthy eye development.

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The team noted some limitations of the study, including the small subject group and the inability to directly measure internal lens changes, as the bright backgrounds used to mimic the outdoors made pupils too small for standard equipment.

Researchers believe that increasing indoor brightness during close-up work could be a simple, testable way to slow the global nearsightedness epidemic. (iStock)

“This is not a final answer,” Jose-Manuel Alonso, MD, PhD, SUNY distinguished professor and senior author of the study, said in the release.

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“But the study offers a testable hypothesis that reframes how visual habits, lighting and eye focusing interact.”

The study was published in the journal Cell Reports.

Khloe Quill is a lifestyle production assistant with Fox News Digital. She and the lifestyle team cover a range of story topics including food and drink, travel, and health.