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Eye Drops Are Recalled After Being Linked to Vision Loss and 1 Death

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Eye Drops Are Recalled After Being Linked to Vision Loss and 1 Death

The producer of a model of over-the-counter eye drops mentioned that it was recalling the product, EzriCare Synthetic Tears, after it was linked to a drug-resistant micro organism pressure that has brought about not less than one individual’s loss of life and imaginative and prescient loss in 5 others.

The Facilities for Illness Management and Prevention has suggested folks to cease utilizing the attention drops, because the company investigates an outbreak of a pressure of the micro organism pseudomonas aeruginosa, which might trigger infections within the blood, lungs and different components of the physique. This pressure of the micro organism had by no means been recognized in america earlier than the present outbreak and is proof against a category of antibiotics referred to as carbapenems, that are usually thought-about a final resort.

The micro organism pressure had been present in 55 folks in 12 states as of Tuesday, the C.D.C. mentioned. The company mentioned that the infections had brought about one loss of life, imaginative and prescient loss in 5 of 11 individuals who had eye infections, and a few hospitalizations.

International Pharma, the Indian firm that manufactures the EzriCare eye drops, mentioned that it was recalling the attention drops “out of an abundance of warning.”

“International Pharma is totally cooperating with U.S. federal authorities, and is constant to research this matter, however up to now we have now not decided whether or not our manufacturing facility is the supply of the contamination,” the corporate mentioned in an emailed assertion.

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The general public affected by the outbreak used synthetic tears earlier than the infections, the C.D.C. mentioned. That they had reported utilizing greater than 10 manufacturers of synthetic tears, and a few sufferers used a couple of, however EzriCare Synthetic Tears is the most typical model, the company mentioned.

The C.D.C. mentioned that it had discovered the drug-resistant micro organism pressure in opened bottles of the EzriCare eye drops collected from sufferers with and with out eye infections. The company is testing unopened bottles to find out if contamination occurred through the manufacturing course of.

The micro organism pressure was present in folks in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin between Could 2022 and January, based on the C.D.C. Of these 55 instances, 35 have been linked to 4 health-care facility clusters, the company mentioned.

The C.D.C. mentioned that individuals who have used EzriCare Synthetic Tears and who’ve indicators of an eye fixed an infection ought to search medical care instantly. The signs can embody yellow, inexperienced or clear discharge from the attention, redness of the attention or eyelid, elevated sensitivity to gentle and eye ache or discomfort.

Dr. Thomas L. Steinemann, a spokesman for the American Academy of Ophthalmology, mentioned that individuals didn’t must be “too terribly involved” about utilizing different sorts of eye drops.

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“We use them for tears, we use them for antibiotics, we use them to deal with glaucoma.” Dr. Steinemann mentioned. “We use eye drop bottles daily, and I believe for the overwhelming majority of customers of eye drop bottles there’s no trigger for alarm.”

Dr. Steinemann, an ophthalmologist at MetroHealth Medical Heart in Cleveland, famous that the C.D.C. report mentioned the EzriCare synthetic tears have been preservative-free, which implies that, if contaminated, they don’t have something to stop the expansion of micro organism.

He mentioned that medical doctors typically advocate preservative-free synthetic tears to sufferers if they’re utilizing them greater than 4 instances a day as a result of preservatives can worsen eye irritation. He mentioned that he had solely ever heard of preservative-free eye drops that have been obtainable in single-use vials that can’t be closed and used once more later.

“That to me caught out once I learn the C.D.C. report is that, not less than for EzriCare, these merchandise are disbursed in what we name multidose bottles, that means that persons are reusing the bottle,” Dr. Steinemann mentioned. “However the bottle doesn’t have any preservatives, which I believe may set the stage for both contamination or bacterial overgrowth within the bottle.”

When folks use any sort of eye drops, Dr. Steinemann mentioned, they need to wash their palms, shut the bottle after utilizing it and never contact the tip, as a result of that might danger making the drops not sterile. “Don’t contact the bottle to your eye or to your face or to your nostril,” he mentioned.

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EzriCare, a drug firm based mostly in New Jersey, mentioned in an announcement on Wednesday that it didn’t manufacture the attention drops and was concerned solely in designing the product’s label and in advertising and marketing it to clients.

EzriCare mentioned that it was first instructed in regards to the C.D.C. investigation on Jan. 20 and “instantly took motion to cease any additional distribution or sale of EzriCare Synthetic Tears.” The corporate mentioned it had additionally been attempting to contact clients to inform them to cease utilizing the attention drops.

Public well being officers have warned that extra have to be accomplished globally to stem the unfold of drug-resistant infections, which happen when micro organism and fungi evolve to outsmart the antibiotic and antifungal medicine which were developed to destroy them. The extra antibiotics and antifungal medicines are given to folks and livestock, the extra probably resistance will happen, well being officers have mentioned.

Almost 30,000 folks in america died in 2020 from drug-resistant infections, based on an evaluation by the C.D.C., 15 % greater than in 2019. The rise was pushed principally by the coronavirus, which within the early days of the pandemic was a thriller to medical professionals. Many turned to antibiotics to attempt to deal with the sickness earlier than vaccines and different therapies have been obtainable.

Annually, greater than 700,000 folks the world over die from drug-resistant infections. The United Nations warned in 2019 that, with out concerted motion, these infections might kill 10 million folks yearly by 2050 and set off a world financial disaster.

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Insulin Prices Dropped. But Some Poor Patients Are Paying More.

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Insulin Prices Dropped. But Some Poor Patients Are Paying More.

Maricruz Salgado was bringing her diabetes under control. Thanks to a federal program that allowed health clinics that serve poor people to buy drugs at steeply discounted prices, she was able to pay less than $75 for all five of her diabetes medications every three months.

But in July, the cost of three of those drugs soared. Ms. Salgado, who does not have health insurance, suddenly faced costs of hundreds of dollars per month. She could not afford it.

Her doctor switched her to cheaper medicines. Within days of taking one of them, she experienced dizzy spells so severe that she said could barely keep up with her hectic daily schedule as a phlebotomist and an in-home caregiver. By the time she returned to the doctor in September, her blood sugar levels had ticked up.

“We were in a good place,” said Dr. Wesley Gibbert, who treats Ms. Salgado at Erie Family Health Centers, a network of clinics in Chicago that serves patients regardless of their ability to pay. “And then all the medicines had to change.”

The price hikes at the clinic happened for a reason that is symptomatic of the tangled web of federal policies that regulate drug pricing. In 2024, drug makers lowered the sticker price of dozens of common medications, which allowed them to avoid massive penalties imposed by the American Rescue Plan, the Covid relief package passed three years earlier. But that change backfired for low-income people like Ms. Salgado.

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The decision to make these medications more affordable for large swaths of patients has quietly created another problem: a severe financial hit to the clinics that are tasked by the federal government with caring for the country’s poorest people. These nonprofit clinics operate in every state and serve nearly 32.5 million people, or about 10 percent of the country’s population.

“It’s the law of unintended consequences,” said Beth Powell, the director of pharmacy at The Centers, which operates five community health clinics in the Cleveland area. Ms. Powell said that while many consumers benefited from the companies’ decision to lower prices, “for our folks, that is not the case.”

More than 1,000 community health clinics around the country rely on a decades-old federal program that requires drug companies to offer them deep discounts.

Under the 340B program, as it is called, companies typically sell their brand-name drugs to clinics at a discount, at 23 percent or more off the list price. The same discount scheme applies to state Medicaid plans. But if a company raises a drug’s list price above the rate of inflation, a penalty kicks in, forcing it to offer even deeper discounts to the clinics.

For years, that meant that every time a company raised a drug’s list price above inflation, community clinics paid less for it. Many drugs, including insulin, essentially became free.

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But the American Rescue Plan made a major change that hit drug companies with even larger penalties for raising prices. In January 2024, companies that continued to raise a drug’s price would have to pay state Medicaid plans every time those drugs were used, potentially costing the industry billions of dollars.

“That was a bridge too far” for the companies, said Antonio Ciaccia, a drug-pricing researcher who advises state governments and employers.

Manufacturers lowered the price of at least 77 drugs in 2023 and 2024, according to an analysis by a nonprofit that Mr. Ciaccia leads. The list includes widely used asthma drugs like Advair and Symbicort, as well as diabetes treatments like Victoza, which Ms. Salgado used before the change.

Once the pharmaceutical companies lowered their list prices, the inflation penalties evaporated. That meant community clinics had to start paying the usual discounts of 23 percent or more off the list price — far more than the pennies they used to pay.

“Unfortunately, the complexities of the U.S. health care system can reduce access and affordability for many,” Jamie Bennett, a spokeswoman for Novo Nordisk, which makes Victoza, said in a statement. “Even when we lower our prices, too often people don’t receive the savings — this is a problem.” She said the company also has patient assistance programs to make its products more affordable.

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David Bowman, a spokesman for the Health Resources and Services Administration, which oversees the 340B discounts, did not respond to questions about how community health clinics were affected by the lowered drug prices. He said that other recent policies, including directing Medicare to negotiate the price of drugs, had lowered drug costs for low-income patients.

Because of a six-month lag in the way that 340B discounts work, clinics were hit by the change last July. Some clinics began calling patients before their prescriptions expired, offering to switch them to less expensive medicines even though they sometimes had more serious side effects. Others decided to cover the higher out-of-pocket costs, which required dipping into already scarce reserves.

Ms. Salgado said a nurse from Erie called over the summer to tell her about the pricing changes. Until then, she had paid about $15 for a three-month supply of Victoza, which is injected daily to keep blood sugar down. After July, the cost rose to more than $300.

After a few weeks, Ms. Salgado adjusted to the replacement, Byetta, and her dizziness subsided. But the drug must be injected twice a day instead of once. And Ms. Salgado must now use a special pharmacy 20 minutes from her house to qualify for the federal discount on the two insulin drugs she was switched to, the result of increasingly strict rules that companies are imposing on health clinics.

Ms. Salgado, who is 39, said she is determined to avoid the fate of her mother, who died of diabetes complications at 54. But keeping up with frequent pharmacy visits and medication changes is tough. “Sometimes it does get to a point where it’s like, I just don’t want to do this anymore,” she said.

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The changes are also making it harder for community clinics to offer other services.

Under the 340B program, clinics buy the discounted drugs on behalf of their patients. When those patients have insurance, the clinics can then bill insurers for the regular, higher price, pocketing the difference. But now that spread — the difference between how much they pay for the drug and what insurance will cover — has dwindled. That has left clinics with less money to spend on services that are not otherwise covered by government grants or insurance, such as helping patients find housing.

At Valley View Health Center, a network of clinics that serves patients in rural Washington, the 340B money once financed a mental health program that employed eight therapists. In September, the clinic halted the program, laying off the therapists.

“It was such an abrupt change for us that it has definitely affected our ability to care for our patients the way that we needed to,” said Gaelon Spradley, the clinic’s chief executive.

Some patients who have seen costs go up have qualified for patient-assistance programs offered by drug makers. That was the case for Lorena Sarmiento, another patient at Erie Health who uses Lantus, an insulin pen. Last fall, after the 340B discount changed, she was quoted $490 at her pharmacy — the retail price for a box of insulin pens. Erie Health sent her to another pharmacy, which helped her sign up for a manufacturer’s coupon that lowered her cost to $35 per month.

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Doctors and pharmacists at several health clinics said such drug-company assistance programs can be hit or miss. Sometimes they last for a limited time or require that a patient reapply regularly. Patients often have to be legal residents of the United States or have a fixed address.

“It’s a lengthy process, and it’s a lot of hoop-jumping,” said Michael Lin, the chief of pharmacy operations at Family Health Centers in Louisville, Kentucky.

Ms. Sarmiento and her husband, Luis, spend about $500 per month on her medical needs, including special food, medications and a glucose monitor. They are no longer facing the highest insulin price, but their costs are still 10 times what they were just a few months ago, when they spent about $10 on three months’ worth of insulin.

Mr. Sarmiento said he tries not to complain. “You always have to look on the good side,” he said. “But lately, that’s been hard.”

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Nutritionists react to the red food dye ban: 'Took far too long'

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Nutritionists react to the red food dye ban: 'Took far too long'

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The U.S. Food and Drug Administration (FDA) announced a ban this week on red dye No. 3, or erythrosine, from foods and oral medications due to a potential cancer risk.

Food manufacturers have until Jan. 2027 to remove the dye (Red 3) from their products, and drug manufacturers have until Jan. 2028, the Associated Press reported.

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The dye was removed from cosmetics nearly 35 years ago for the same cancer-related concerns.

FDA BANS RED FOOD DYE DUE TO POTENTIAL CANCER RISK

Following the Wednesday announcement of the new ban, nutritionists and other health experts applauded the removal of the additives from America’s food supply.

Los Angeles-based registered dietitian nutritionist Ilana Muhlstein shared excitement about the FDA “finally” banning the synthetic dye that has been in candy, cereals and strawberry-flavored drinks for “far too long.”

Red 3 can be found in a variety of food products, most commonly candies and colorful sweets. (iStock)

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“What is wild is that this decision comes over three decades after the same dye was banned in cosmetics like lipstick because there was enough evidence linking it to cancer in animals,” she told Fox News Digital.

CALIFORNIA PROPOSES BILL TO BAN SOME FOOD PRODUCTS WHILE NUTRITIONISTS FRET ABOUT ‘GROSS’ INGREDIENTS

“For years, consumer advocacy groups and researchers have pushed for this change, citing not only cancer risks but also potential links to hyperactivity and ADHD in kids.”

Certified holistic nutritionist and The Power of Food Education founder Robin DeCicco, based in New York, commented that “it’s about time” Red 3 was banned.

Woman eating candy

A certified holistic nutritionist (not pictured) warned that red dye No. 3 appears in some products that “you’d never expect.” (iStock)

“It never made sense to me why the dye was taken out of lipsticks and blushes 30 years ago but has been allowed to be in our food supply,” she reiterated to Fox News Digital. “There has been evidence of the dye causing cancer in rats for decades.”

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“Our kids deserved better, and it’s frustrating that it took this long for action to be taken.”

While the ban is an “obvious win for public health,” she still feels “frustrated” that it took so long, she said.

“The FDA became aware of the risks in the 1980s, and other countries, like those in the EU, banned red dye No. 3 years ago,” she noted. “Yet big food manufacturers lobbied hard to delay this decision because these artificial dyes are cheap, convenient and profitable.”

strawberry milk

Red dye No. 3 is often used in strawberry flavoring, according to experts. (iStock)

The dye was commonly used in products that are primarily marketed to children, she noted, such as colorful lollipops, candies and breakfast cereals.

“Our kids deserved better, and it’s frustrating that it took this long for action to be taken,” Muhlstein added.

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‘Stay informed’

The ban is a “step forward,” but Muhlstein said it’s also a reminder to “stay informed about what we’re feeding our families.”

Red dye No. 3 is included in other products that aren’t so obvious, including some pre-packaged vegan meats, fruit cups, mini muffin snacks, mashed potatoes, yellow rice and sugar-free water flavors, according to experts.

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DeCicco encouraged consumers to always read the ingredient label and to look for natural replacements for these products.

Kid eating sugary cereal

The dye was commonly used in products that are primarily marketed to children, such as colorful lollipops, candies and breakfast cereals. (iStock)

“It’s not about deprivation or restriction – I always say it’s about eating foods with high-quality ingredients,” she said. “The ingredients matter more than anything else, and they’re out there.”

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“I have worked with many families with kids who have ADHD, and removing sugar and artificial food dyes and additives can in some cases lessen symptoms (as one part of treatment),” DeCicco added.

Colorful food without carcinogens

While nutritionists recommend that consumers stay away from foods that contain red dye or erythrosine on the label, there are healthier, natural alternatives to keep food fun.

pink cupcakes in a tray

Using alternatives for red dye like pomegranate juice or fruit powder can keep food fun, according to nutritionists. (iStock)

Muhlstein recommended adding 1 to 2 tablespoons of pomegranate juice to a baking recipe, such as vanilla cake, to give the batter a natural red hue.

She also suggested mixing crushed-up, freeze-dried strawberries into white frosting or whipped cream.

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“Beetroot powder, hibiscus powder and even mashed raspberries are great alternatives, too,” she added.

Fox News Digital’s Melissa Rudy contributed reporting. 

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Mom’s Gripes About Sister-in-Law Put Daughter in a Bind

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Mom’s Gripes About Sister-in-Law Put Daughter in a Bind

My mother is hypercritical of my brother’s wife, to the point that she blames my sister-in-law for my brother’s “failings” (not getting a better job, not taking better care of his health, etc.). It has gotten worse now that there are grandchildren. My mother constantly criticizes how my sister-in-law is raising the kids, who are lovely and adore their grandparents.

Although my mother will occasionally raise criticisms with my sister-in-law and brother, I am mostly her audience.

I have a great relationship with my sister-in-law, and when my mother goes off on one of her rants, I defend her. I tell my mother how lucky she is to have such wonderful grandchildren, and point out that my brother is an adult who makes his own decisions. This just leads to an argument between my mother and me.

When I finally told my mother how much it hurts me to hear her say these things about my sister-in-law, she said that she needed to air her frustrations with someone. I want to be there for my mother, but I don’t like being put in this position. How do I navigate this?

From the Therapist: The short answer to your question is that you can navigate this by no longer engaging in these conversations. But I imagine you already know this. What you might be less aware of is that you aren’t being “put in this position” of supportive daughter, protective sister-in-law and unwilling confidante. You’ve chosen it, and it’s worth examining why you’ve signed up for a job you don’t want — and what makes it hard to resign.

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Usually when we find ourselves repeatedly engaging in uncomfortable family patterns, it’s because they echo familiar roles from our childhood. It sounds as if you’re struggling with enmeshment, a relationship pattern in which boundaries between family members become blurred or are nonexistent.

Think of enmeshment as being like two trees that have grown so close together that their branches have become intertwined. While this might look like closeness, it actually prevents either tree from growing in a healthy way. In your case, your mother’s emotions and grievances have become so entangled with your own emotional life that it’s hard to distinguish where her feelings end and yours begin.

You mention wanting to “be there” for your mom even though these conversations hurt you. Many adult children who struggle to say no to their parents grew up serving as their parents’ emotional support system, or absorbing their parents’ feelings, even at the expense of their own. When you told your mother how much her venting hurt you, she responded not by acknowledging your feelings, but by asserting her need to “air her frustrations.” Her response reveals something important: She sees you as a vessel for her emotional overflow rather than as someone with valid feelings of your own. And yet, despite your hurt, you’re still more concerned about her feelings than yours.

You’re asking how to navigate this situation, but I think the deeper question is: How can you begin to value your own emotional needs?

You can start by reframing what it means to make a reasonable request, which is essentially what setting a boundary is. A boundary isn’t about pushing someone away. Instead, it’s about making a bid for connection. It’s saying:I want to feel good being close to you, but when you do X, it makes me want to avoid you. Help me come closer.”

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Establishing a boundary consists of three steps:

  • State the issue and the desire to come closer (what will make this possible): “Mom, I love you and want to support you, but these conversations about my sister-in-law put me in an impossible position and make me want to avoid talking with you, which I know isn’t what either of us wants. I’m happy to talk about other things together, but in order to keep our relationship strong, I need this topic to be off limits.”

  • Set the boundary (what you will do): “If you’re struggling with their choices, I’m happy to support you in finding a therapist who can help you work through these feelings. But if you bring up these frustrations with me, I’m going to end the conversation and we can talk another time about other things.”

  • Hold the boundary (do what you say): A boundary isn’t about what the other person will or won’t do. A boundary is a contract with yourself. If you say you’ll end the conversation when your mom brings up your sister-in-law, you need to hold that boundary every single time. If you end the conversation only 90 percent of the time, then why would the other person honor your request when 10 percent of the time, you can’t honor it yourself? Honoring your request might sound like: “Mom, I’m going to end the conversation now because I’m not comfortable talking about my sister-in-law. I love you, and we’ll talk later.”

If you start to feel guilty, remember that just because someone sends you guilt doesn’t mean you have to accept delivery. Remind yourself that when you become your mother’s outlet for criticism of your sister-in-law, you’re participating in a cycle that strains loyalties and causes you personal distress. And keep in mind that being a good daughter means setting boundaries that encourage our parents to grow, rather than enabling patterns that harm our family relationships.

Want to Ask the Therapist? If you have a question, email askthetherapist@nytimes.com. By submitting a query, you agree to our reader submission terms. This column is not a substitute for professional medical advice.

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