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SCOTUS mifepristone case: Justices focus on anti-abortion groups’ legal standing

Par : Beth Mole
Demonstrators participate in an abortion-rights rally outside the Supreme Court as the justices of the court hear oral arguments in the case of the <em>US Food and Drug Administration v. Alliance for Hippocratic Medicine</em> on March 26, 2024 in Washington, DC.

Enlarge / Demonstrators participate in an abortion-rights rally outside the Supreme Court as the justices of the court hear oral arguments in the case of the US Food and Drug Administration v. Alliance for Hippocratic Medicine on March 26, 2024 in Washington, DC. (credit: Getty | Anna Moneymaker)

The US Supreme Court on Tuesday heard arguments in a case seeking to limit access to the abortion and miscarriage drug mifepristone, with a majority of justices expressing skepticism that the anti-abortion groups that brought the case have the legal standing to do so.

The case threatens to dramatically alter access to a drug that has been safely used for decades and, according to the Guttmacher Institute, was used in 63 percent of abortions documented in the health care system in 2023. But, it also has sweeping implications for the Food and Drug Administration's authority over drugs, marking the first time that courts have second-guessed the agency's expert scientific analysis and moved to restrict access to an FDA-approved drug.

As such, the case has rattled health experts, reproductive health care advocates, the FDA, and the pharmaceutical industry alike. But, based on the line of questioning in today's oral arguments, they have reason to breathe a sigh of relief.

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Lifesaving gene therapy for kids is world’s priciest drug at $4.25M

Par : Beth Mole
A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

Enlarge / A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004. (credit: Getty | John Ewing/Portland Press Herald)

In a medical triumph, the US Food and Drug Administration on Monday approved a gene therapy that appears to trounce a rare, tragic disease that progressively steals children's ability to talk, move, and think, leading to a vegetative state and death. For those who begin to slip away in infancy, many die by age 5. But, with the new therapy, 37 children in an initial trial were all still alive at age 6. Most could still talk, walk on their own, and perform normally on IQ tests, which was unseen in untreated children. Some of the earliest children treated have now been followed for up to 12 years—and they continue to do well.

But, the triumph turned bittersweet today, Wednesday, as the company behind the therapy, Lenmeldy, set the price for the US market at $4.25 million, making it the most expensive drug in the world. The price is $310,000 higher than what experts calculated to be the maximum fair price for the lifesaving drug; the nonprofit Institute for Clinical and Economic Review, or ICER, gave a range last October of between $2.29 million to $3.94 million.

The price raises questions about whether state, federal, and private health insurance plans will be able to shoulder the costs. "Unless states have allocated appropriately for it, and looked at the drug pipeline, they may not be prepared for what could be significant cost spikes," Edwin Park, a research professor at the McCourt School of Public Health at Georgetown University, told CNN.

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Deadly morel mushroom outbreak highlights big gaps in fungi knowledge

Par : Beth Mole
Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China's Ningxia Hui Autonomous Region.

Enlarge / Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China's Ningxia Hui Autonomous Region. (credit: Getty | Xinhua/Wang Peng)

True morel mushrooms are widely considered a prized delicacy, often pricey and surely safe to eat. But these spongey, earthy forest gems have a mysterious dark side—one that, on occasion, can turn deadly, highlighting just how little we know about morels and fungi generally.

On Thursday, Montana health officials published an outbreak analysis of poisonings linked to the honeycombed fungi in March and April of last year. The outbreak sickened 51 people who ate at the same restaurant, sending four to the emergency department. Three were hospitalized and two died. Though the health officials didn't name the restaurant in their report, state and local health departments at the time identified it as Dave’s Sushi in Bozeman. The report is published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.

The outbreak coincided with the sushi restaurant introducing a new item: a "special sushi roll" that contained salmon and morel mushrooms. The morels were a new menu ingredient for Dave's. They were served two ways: On April 8, the morels were served partially cooked, with a hot, boiled sauce poured over the raw mushrooms and left to marinate for 75 minutes; and on April 17, they were served uncooked and cold-marinated.

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Apple’s AirPods Pro could be getting a “hearing aid mode” later this year

AirPods arranged at an Apple Store

Enlarge / Apple AirPods on display at the company's Fifth Avenue store in New York in Feb. 2024. (credit: Bing Guan/Bloomberg via Getty Images)

Apple's AirPods Pro are getting closer to becoming fully fledged hearing aids and marketed as such, according to Bloomberg's Mark Gurman. The move could have a large impact on the hearing aid market, which has already been recently shaken up by over-the-counter models.

Gurman writes that AirPods Pro are due to receive a hearing-aid function in iOS 18, arriving this fall and likely to be announced and outlined at a Worldwide Developers Conference in June. The Wall Street Journal reported in the fall of 2021 that Apple was working toward a future AirPods Pro model that functioned as a hearing aid and would also be able to monitor body posture and even body temperature.

It was not clear from Gurman or the Journal's reporting whether the hearing aid function would be available only in a new model of AirPods Pro or offered as a software update on prior models. Since the Journal's report, Apple has released both a second-generation model of AirPods Pro and a refresh of that model with a USB-C port.

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Don’t use these six cinnamon products, FDA warns after concerning lead tests

Par : Beth Mole
Don’t use these six cinnamon products, FDA warns after concerning lead tests

Enlarge (credit: Getty | Hoberman Collection)

Six different ground cinnamon products sold at retailers including Save A Lot, Dollar Tree, and Family Dollar contain elevated levels of lead and should be recalled and thrown away immediately, the US Food and Drug Administration announced Wednesday.

The brands are La Fiesta, Marcum, MK, Swad, Supreme Tradition, and El Chilar, and the products are sold in plastic spice bottles or in bags at various retailers. The FDA has contacted the manufacturers to urge them to issue voluntary recalls, though it has not been able to reach one of the firms, MTCI, which distributes the MK-branded cinnamon.

The announcement comes amid a nationwide outbreak of lead poisoning in young children linked to cinnamon applesauce pouches contaminated with lead and chromium. In that case, it's believed that a spice grinder in Ecuador intentionally added extreme levels of lead chromate to cinnamon imported from Sri Lanka, likely to improve its weight and/or appearance. Food manufacturer Austrofoods then added the heavily contaminated cinnamon, without any testing, to cinnamon applesauce pouches marketed to toddlers and young children across the US. In the latest update, the Centers for Disease Control and Prevention has identified 468 cases of lead poisoning that have been linked to the cinnamon applesauce pouches. The cases span 44 states and are mostly in very young children.

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New FDA-approved drug makes severe food allergies less life-threatening

Par : Beth Mole
Peanuts

Enlarge / Peanuts (credit: Getty | CFOTO/Future Publishing)

Living with food allergies can be a fraught existence. There is no cure, and the standard management is to be ever vigilant of everything you eat and have an emergency shot of epinephrine constantly handy in case an accidental ingestion leads to a swift, life-threatening reaction. But, for the millions of people in the US who live with such allergies, a new drug may dull the threat.

On Friday, the Food and Drug Administration approved the antibody drug omalizumab (brand name Xolair) as an injection to lessen allergic reactions to foods in people ages 1 and up. In a trial of 168 children and adults with multiple food allergies, participants who received shots of omalizumab for 16 to 20 weeks were much more likely to tolerate a test dose of allergy-inducing foods at the end than those who received a placebo.

Omalizumab—which was previously approved to treat asthma, hives, and nasal polyps—works by binding to a class of antibodies in the body called immunoglobulin E (IgE) that are specifically involved in allergic responses. The monoclonal antibody drug binds IgE, blocking it from binding to its target receptor, thus preventing it from triggering the immune responses that lead to allergy symptoms.

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Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

Par : Beth Mole
Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

Enlarge (credit: Nozin.com)

More than four years after SARS-CoV-2 made its global debut, the US Food and Drug Administration is still working to clear out the bogus and unproven products that flooded the market claiming to prevent, treat, and cure COVID-19.

The latest example is an alcohol-based sanitizer meant to be smeared inside the nostrils. According to its maker, the rub can protect you from becoming infected with SARS-CoV-2 and other nasty germs, like MRSA, and that protection lasts up to 12 hours after each swabbing. That all sounds great, but according to the FDA, none of it is proven. In a warning letter released Tuesday, the agency determined the sanitizer, called Nozin, is an unapproved new drug and misbranded.

While ethyl alcohol is used in common topical antiseptics, like hand sanitizers, the FDA does not generally consider it safe for inside the nostrils—and the agency is unaware of any high-quality clinical data showing that Nozin is safe, let alone effective. The FDA also noted that, for general over-the-counter topical antiseptics, calling out specific pathogens it can fight off—like SARS-CoV-2 and MRSA—is not allowed under agency rules without further FDA review. Making claims about protection duration is also not allowed.

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We may now know who’s behind the lead-tainted cinnamon in toddler fruit pouches

Par : Beth Mole
The three recalled pouches linked to lead poisonings.

Enlarge / The three recalled pouches linked to lead poisonings. (credit: FDA)

A spice grinder named Carlos Aguilera of Ecuador is the likely source of contaminated cinnamon containing extremely high levels of lead and chromium, which made its way into the apple cinnamon fruit pouches of US toddlers, according to an announcement by the Food and Drug Administration this week.

To date, there have been 413 cases of poisoning across 43 US states, according to the Centers for Disease Control and Prevention.

The FDA said Ecuadorian officials at the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) identified Aguilera as the cinnamon processor and reported to the FDA that his business is no longer operating. Aguilera received raw cinnamon sticks sourced from Sri Lanka, which, according to raw sample testing conducted by ARCSA, had no lead contamination upon their arrival. After Aguilera processed the cinnamon, it was supplied by a company called Negasmart to Austrofoods, the manufacturer of the apple cinnamon pouches.

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Anti-abortion group’s studies retracted before Supreme Court mifepristone case

Par : Beth Mole
Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.

Enlarge / Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022. (credit: Getty | Robyn Beck)

Scientific journal publisher Sage has retracted key abortion studies cited by anti-abortion groups in a legal case aiming to revoke regulatory approval of the abortion and miscarriage medication, mifepristone—a case that has reached the US Supreme Court, with a hearing scheduled for March 26.

On Monday, Sage announced the retraction of three studies, all published in the journal Health Services Research and Managerial Epidemiology. All three were led by James Studnicki, who works for The Charlotte Lozier Institute, a research arm of Susan B. Anthony Pro-Life America. The publisher said the retractions were based on various problems related to the studies' methods, analyses, and presentation, as well as undisclosed conflicts of interest.

Two of the studies were cited by anti-abortion groups in their lawsuit against the Food and Drug Administration (Alliance for Hippocratic Medicine v. FDA), which claimed the regulator's approval and regulation of mifepristone was unlawful. The two studies were also cited by District Judge Matthew Kacsmaryk in Texas, who issued a preliminary injunction last April to revoke the FDA's 2000 approval of mifepristone. A conservative panel of judges for the 5th Circuit Court of Appeals in New Orleans partially reversed that ruling months later, but the Supreme Court froze the lower court's order until the appeals process had concluded.

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Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal

Par : Beth Mole
Multistory glass office building.

Enlarge / The exterior of the headquarters of biotechnology company Biogen in Cambridge, Massachusetts. (credit: Getty | Boston Globe)

Biotechnology company Biogen is abandoning Aduhelm, its questionable Alzheimer's drug that has floundered on the market since its scandal-plagued regulatory approval in 2021 and brow-raising pricing.

On Wednesday, the company announced it had terminated its license for Aduhelm (aducanumab) and will stop all development and commercialization activities. The rights to Aduhelm will revert back to Neurimmune, the Swiss biopharmaceutical company that discovered it.

Biogen will also end the Phase 4 clinical trial, ENVISION, that was required by the Food and Drug Administration to prove Biogen's claims that Aduhelm is effective at slowing progression of Alzheimer's in its early stages—something two Phase 3 trials failed to do with certainty.

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COVID shots protect against COVID-related strokes, heart attacks, study finds

Par : Beth Mole
A vial of the updated 2023-2024 formula of Pfizer's COVID-19 vaccine at a CVS Pharmacy in Eagle Rock, California, on September 14, 2023.

Enlarge / A vial of the updated 2023-2024 formula of Pfizer's COVID-19 vaccine at a CVS Pharmacy in Eagle Rock, California, on September 14, 2023. (credit: Getty | Irfan Khan)

Staying up to date on COVID-19 vaccines can cut the risk of COVID-related strokes, blood clots, and heart attacks by around 50 percent in people ages 65 years or older and in those with a condition that makes them more vulnerable to those events, according to a new study from the Centers for Disease Control and Prevention.

The finding, published this week in the CDC's Morbidity and Mortality Weekly Report, should help ease concerns that the shots may conversely increase the risk of those events—collectively called thromboembolic events. In January 2023, the CDC and the Food and Drug Administration jointly reported a preliminary safety signal from their vaccine-monitoring systems that indicated mRNA COVID-19 vaccines may increase the risk of strokes in the 21 days after vaccination of people ages 65 and older. Since that initial report, that signal decreased, becoming statistically insignificant. Other vaccine monitoring systems, including international systems, have not picked up such a signal. Further studies (summarized here) have not produced clear or consistent data pointing to a link to strokes.

In May, the FDA concluded that the evidence does not support any safety concern and reported that "scientists believe factors other than vaccination might have contributed to the initial finding."

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US verges on vaccination tipping point, faces thousands of needless deaths: FDA

Par : Beth Mole
A child with measles.

Enlarge / A child with measles. (credit: Greene, Charles Lyman)

The US may be heading to a "dangerous vaccination tipping point," with immunization rates falling so low that population-level immunity is now at risk, and we will likely see thousands of needless deaths this respiratory virus season, two top officials for the Food and Drug Administration warned in a recent JAMA commentary.

FDA Commissioner Robert Califf and top FDA vaccine regulator Peter Marks noted the profound benefits of vaccines—which save millions of lives in the US each year—and their established safety, which is monitored both passively and actively through multiple overlapping federal safety monitoring systems. And yet, "an increasing number of people in the US are now declining vaccination for a variety of reasons, ranging from safety concerns to religious beliefs," thanks to the rise of anti-vaccine misinformation spread on social media and elsewhere on the Internet.

Data from the Centers for Disease Control and Prevention last year found that, for the third consecutive year, vaccination rates among kindergartners had continued to slip, with rates of non-medical vaccination exemptions rising to an all-time high. There are now 10 states with vaccination exemption rates over 5 percent, meaning that even if clinicians and health officials manage to vaccinate all non-exempt children, the state will not be able to reach the target of 95 percent coverage needed to curb the spread of disease on a population level.

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Canada vows to defend its drug supply against Florida importation plan

Par : Beth Mole
A Royal Canadian Mounted Police officer stands guard outside the Senate of Canada prior to the Speech from the Throne on September 23, 2020, in Ottawa.

Enlarge / A Royal Canadian Mounted Police officer stands guard outside the Senate of Canada prior to the Speech from the Throne on September 23, 2020, in Ottawa. (credit: Getty | DAVE CHAN/AFP)

Canada issued a warning Monday that it stands ready to defend its prescription drug supply from US importation plans—and also said the plans wouldn't work for the US, anyway. "Bulk importation will not provide an effective solution to the problem of high drug prices in the US," Health Canada said in a statement.

The defensive stance comes just days after the US Food and Drug Administration granted Florida authorization to directly import cheaper prescription drugs from Canada in an effort to help drag down America's uniquely stratospheric drug pricing. Florida is the first state to win such an authorization, and Florida Governor Ron DeSantis celebrated it, claiming the drug imports will save the state "up to $180 million in the first year alone." There are caveats, though. Before Florida can import any drugs, it must complete several obligations, including submitting to the FDA additional drug-specific information, testing the drugs for authenticity and FDA compliance, and relabeling them in accordance with FDA labeling.

The FDA authorized the importation program in accordance with section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The move stems from President Biden’s "Executive Order on Promoting Competition in the American Economy," which directed the FDA to help develop such programs.

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Chromium found in lead-tainted fruit pouches may explain contamination

Par : Beth Mole
The three recalled pouches linked to lead poisonings.

Enlarge / The three recalled pouches linked to lead poisonings. (credit: FDA)

The Food and Drug Administration has discovered a second metal contaminant—chromium—in the recalled cinnamon applesauce pouches found to contain cinnamon contaminated with extremely high levels of lead. The products have now poisoned nearly 300 young children in 37 states.

The health implications of the additional contaminant are not clear. There is no antidote for chromium exposure, and the Centers for Disease Control and Prevention recommends supportive care. But the finding does hint at the possible motivation behind the tragic poisonings.

In the FDA's announcement, the agency noted that "The lead-to-chromium ratio in the cinnamon apple puree sample is consistent with that of lead chromate (PbCrO4)." This is a notorious adulterant of spices used to artificially bolster their color and weight.

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FDA would like to stop finding Viagra in supplements sold on Amazon

Image of a pile of blue pills that forms the shape of a male symbol.

Enlarge (credit: Viaframe)

If you were to search for a product called “Mens Maximum Energy Supplement" on Amazon, you'd be bombarded with everything from caffeine pills to amino acid supplements to the latest herb craze. But at some point last year, the FDA had purchased a specific product by that name from Amazon and sent it off to one of its labs to find out if the self-proclaimed "dietary supplement" contained anything that would actually boost energy.

In August, the FDA announced that the supposed supplement was actually a vehicle for a prescription drug that offered a very specific type of energy boost. It contained sildenafil, a drug much better known by its brand name: Viagra.

Four months later, the FDA is finally getting around to issuing a warning letter to Amazon, giving it 15 days to not only address Mens Maximum Energy Supplement and a handful of similar vehicles for prescription erection boosters, but also asking for an explanation of how the company is going to keep similarly mislabelled prescription drugs from being hawked on its site in the future.

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MDMA—aka ecstasy—submitted to FDA as part of PTSD therapy

Par : Beth Mole
Girl with an ecstasy tablet on her tongue.

Enlarge / Girl with an ecstasy tablet on her tongue. (credit: Getty | UniversalImagesGroup)

A corporation dedicated to studying the benefits of psychedelic drugs filed an application with the Food and Drug Administration this week for approval to use MDMA—aka ecstasy or molly—in combination with talk therapy to treat post-traumatic stress disorder.

If approved, it would be the first-of-its-kind combination treatment—a psychedelic-assisted therapy. An approval would also require the Drug Enforcement Administration to reclassify MDMA, which is currently in the DEA's most restricted category, Schedule I, which is defined as drugs "with no currently accepted medical use and a high potential for abuse." The category also includes LSD, heroin, and marijuana.

The public benefit corporation (PBC) that filed the FDA application was created by MAPS, The Multidisciplinary Association for Psychedelic Studies, which has been supporting this type of work since 1986. The application is based on positive data from two randomized, double-blind, placebo-controlled Phase III studies, which were funded and organized by MAPS and MAPS PBC.

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Every homeopathic eye drop should be pulled off the market, FDA says

Par : Beth Mole
Young man applying eye drops.

Enlarge (credit: Getty | UniversalImagesGroup)

This year has been marked by many terrifying things, but perhaps the most surprising of the 2023 horrors was … eye drops.

The seemingly innocuous teeny squeeze bottle made for alarming headlines numerous times during our current revolution around the sun, with lengthy lists of recalls, startling factory inspections, and ghastly reports of people developing near-untreatable bacterial infections, losing their eyes and vision, and dying.

Recapping this unexpected threat to health, the Food and Drug Administration on Tuesday released an advisory titled "What You Should Know about Eye Drops" in hopes of keeping the dangers of this year from leaking into the next. Among the notable points from the regulator was this stark pronouncement: No one should ever use any homeopathic ophthalmic products, and every single such product should be pulled off the market.

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Barefoot workers, bacteria found at factory that made big-brand eye drops

Par : Beth Mole
Eye drop over woman's eye.

Enlarge / Eye drop over woman's eye. (credit: Getty | AGF)

The Indian manufacturing facility that made generic eye drops sold under CVS, Target, Rite Aid, and Walmart brands had a slew of manufacturing violations, including allowing workers to regularly perform their roles barefoot and failing to document bacterial contamination, according to an inspection report released by the Food and Drug Administration.

Last month, the regulator warned consumers to immediately stop using over two dozen kinds of big-brand eye drops due to a risk of infection. The list has since been updated to include a few more products. In addition to the big store brands, the eye drops were also sold as Leader (Cardinal Health), Rugby (Cardinal Health), and Velocity Pharma branded products.

All of the products are made by Kilitch Healthcare India Limited in Mumbai. At the time of the FDA's initial warning, the agency said it had found bacterial contamination in critical production areas of the Mumbai facility. As such, the agency warned of a possibility that the products, which are intended to be sterile, may not be and could pose a risk of infection.

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Lead-tainted fruit pouches poison 22 toddlers; blood lead levels 8x threshold

Par : Beth Mole
The three pouches so far linked to lead contamination.

Enlarge / The three pouches so far linked to lead contamination. (credit: FDA)

At least 22 toddlers across at least 14 states have suffered acute lead poisoning linked to recalled apple cinnamon fruit puree pouch products found to contain "extremely high levels of lead."

The products contained such high lead levels that some of the poisoned toddlers showed blood lead levels as high as 29 micrograms per deciliter (µg/dL), roughly eightfold above the federal reference level of 3.5 µg/dL to identify children at high exposure.

Given that at least one of the recalled products (WanaBana) was sold nationally and through multiple retailers, including Amazon and Dollar Tree, there are likely more cases in more states.

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Toxic toddler fruit pouches: “Extremely high” lead levels sicken 7 in 5 states

Par : Beth Mole
The three pouches so far linked to lead contamination.

Enlarge / The three pouches so far linked to lead contamination. (credit: FDA)

At least seven children across five states have suffered acute lead poisoning linked to at least three brands of apple cinnamon fruit puree pouches marketed to children and sold nationwide, the Food and Drug Administration announced in an updated safety alert Friday.

The brands include WanaBana apple cinnamon fruit puree pouches, Schnucks brand cinnamon-flavored applesauce pouches, and Weis brand cinnamon applesauce pouches. All three have been recalled. Consumers should not buy, sell, serve, or eat any of these products. Any pouches that have already been purchased should be thrown away. Parents or guardians of any children who may have eaten the purees should talk with health care providers about blood lead tests.

In an October 28 alert, the FDA said it was working with authorities in the state of North Carolina who had identified four children with elevated blood lead levels in the western part of the state. North Carolina considers a child to have elevated blood lead levels if they have two consecutive blood lead test results greater than or equal to 5 micrograms per deciliter (µg/dl)—at which point the child becomes eligible for an investigation into the lead source. The Centers for Disease Control and Prevention meanwhile has a threshold of 3.5 µg/dl to consider a blood lead level high, which corresponds to the 97.5th percentile of blood levels in a survey of US children.

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Soda additive linked to thyroid toxicity may finally get banned by FDA

Par : Beth Mole
Sundrop is among the citrus soft drinks that still contains BVO.

Enlarge / Sundrop is among the citrus soft drinks that still contains BVO. (credit: Sun Drop)

The Food and Drug Administration may finally ban a food additive used in citrusy drinks that the agency determined over 50 years ago could not be considered generally safe. The agency proposed a ban on the additive Thursday.

The additive is brominated vegetable oil (BVO), which is a flavoring emulsifier and stabilizer that has been used to keep citrus flavoring from separating and floating to the top of soft drinks since the 1920s. It was previously used in big brand-name beverages such as Mountain Dew and Gatorade but has been removed amid toxicity concerns in recent years. Since at least 2014, PepsiCo and Coca-Cola have been phasing out BVO from their drinks, though it can still be found in some store-brand sodas and regional drinks, including the citrus soda Sun Drop.

BVO is already banned in Europe, Japan, Australia, and New Zealand. In October of this year, California banned BVO, along with other problematic food additives, including red dye No. 3. (While reporting California's ban on red dye No. 3, Ars also reported that the FDA planned to ban BVO.)

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FDA warns of infection risk from 26 big-brand eye drops; stop using immediately

Par : Beth Mole
Young man applying eye drops.

Enlarge (credit: Getty | UniversalImagesGroup)

The Food and Drug Administration is warning consumers to ditch 26 over-the-counter eye drop products found at big retailers—including CVS, Rite Aid, and Target—due to a risk of infection. Consumers should not buy any of the products and should immediately stop using them if they've already purchased them.

The products include Target's branded Up & Up Dry Eye Relief Lubricant Eye Drops and Up & Up Extreme Relief Dry Eye, as well as Lubricant Eye Drops and Lubricant Gel Drops branded by CVS Health and Rite Aid. The warning also includes eye drop products branded as Rugby and Leader (both from Cardinal Health) and Velocity Pharma. A full list can be found here, as can links to report adverse events.

In an advisory posted Friday, the FDA reported that no infections or adverse events have been linked to the products so far. But the agency said it "found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility."

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CVS ditches common cold meds after FDA advisers say they’re useless

Par : Beth Mole
A box of Sudafed PE sinus pressure and pain medicine containing phenylephrine is displayed for sale in a CVS Pharmacy store in Hawthorne, California, on September 12, 2023.

Enlarge / A box of Sudafed PE sinus pressure and pain medicine containing phenylephrine is displayed for sale in a CVS Pharmacy store in Hawthorne, California, on September 12, 2023. (credit: Getty | PATRICK T. FALLON)

Drug store giant CVS revealed late last week that it is voluntarily pulling some common cold and flu medicines from its shelves because they don't work—while many other ineffective products remain on the shelves.

The move by CVS comes after an advisory panel for the Food and Drug Administration last month voted unanimously that the common decongestant, phenylephrine, is ineffective at treating a stuffy nose. But it comes ahead of the FDA itself acting on the vote, which will likely lead the agency to revoke phenylephrine's approval, eventually.

In a statement to Ars, a CVS spokesperson suggested the FDA advisory panel's vote was the impetus for the change, but that it would "follow direction from the FDA."

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The data and puzzling history behind California’s new red food dye ban

Par : Beth Mole
The famous Easter candy Peeps, made by Just Born Quality Confections, are displayed on April 7, 2023 in New York, US. Consumer Reports announced in a recent press release that it had contacted Just Born Quality Confections earlier this year about concerns over the company's use of red dye No. 3 in the Peeps candies, which has been found to cause cancer in animals.

Enlarge / The famous Easter candy Peeps, made by Just Born Quality Confections, are displayed on April 7, 2023 in New York, US. Consumer Reports announced in a recent press release that it had contacted Just Born Quality Confections earlier this year about concerns over the company's use of red dye No. 3 in the Peeps candies, which has been found to cause cancer in animals. (credit: Getty | Fatih Aktas)

Last weekend, California outlawed a common red food dye that is otherwise deemed safe by the Food and Drug Administration—the first such ban in the country and one that puzzlingly comes over three decades after the FDA determined the dye causes cancer in rats and banned it from lipsticks and other cosmetics, but not foods.

The dye is FD&C Red No. 3, also known as red dye No. 3. Today, it is found in thousands of food products—from Brach's Candy Corn and varieties of Nerds, Peeps, Pez, candy canes, Fruit by the Foot, to Entenmann's Little Bites Mini Muffins, Betty Crocker mashed potatoes, fruit cocktail, PediaSure nutritional shakes, and MorningStar Farm's veggie bacon strips.

But, back in 1990, the FDA carefully reviewed decades' worth of animal studies on red dye No. 3 and determined that "FD&C Red No. 3 has been shown to induce cancer in appropriate tests," and is therefore "unsafe for use in externally applied drugs and externally applied cosmetics and cannot be listed." Even though the risk appeared small, the agency's decision hinged on the Delaney Clause of 1958, which requires the FDA to ban any food additive that is shown to induce cancer in humans or animals.

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“Church of Bleach” family gets years in prison for deadly “miracle” solution

Par : Beth Mole
Bottles of MMS, a bleach product sold by Genesis II Church of Health and Healing.

Enlarge / Bottles of MMS, the bleach product that Genesis II Church of Health and Healing was ordered to stop selling. (credit: Genesis II Church of Health and Healing)

A federal judge in Miami has handed down years-long prison sentences to a Florida father and his three adult sons who were convicted in July of using a faux church to sell an industrial-strength bleaching agent as a "miracle" solution they falsely claimed could cure serious illnesses such as cancer, HIV/AIDS, and COVID-19.

Father Mark Grenon, 66—the patriarch of the so-called "Church of Bleach"—and one of his sons, Joseph Grenon, 36, were sentenced to 60 months in prison (five years). That's the statutory maximum sentence for their conviction of conspiring to defraud the US by distributing an unapproved and misbranded drug.

Jonathan Grenon, 37, and Jordan Grenon, 29, received longer sentences of 151 months in prison (12 years and seven months), because they were convicted of contempt of court as well as conspiring to defraud the US.

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After COVID killed off a flu strain, annual flu shots are in for a redesign

Par : Beth Mole
Graphical depiction of a virus.

Enlarge / The flu virus, showing the H and N proteins on its surface. (credit: CDC)

Vaccine advisers for the Food and Drug Administration voted unanimously (12 to 0) Thursday to remove, "as soon as possible," a component of annual flu shots that targets a strain of the virus that appears to have gone extinct amid the COVID-19 pandemic.

The vote follows a similar recommendation from the World Health Organization last week, which stated that "every effort should be made to exclude this component as soon as possible."

Exactly how soon that removal could happen is unclear, though, and some advisers on the FDA's panel expressed frustration that plans for the removal appear to have been slow-walked in the last couple of years, as it only became more apparent that the strain may be gone for good.

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Probiotic bacterium kills preterm infant; FDA blasts supplement maker

Par : Beth Mole
A premature baby in the neonatal intensive care unit at University of Iowa Stead Family Children's Hospital in Iowa City, Iowa on August 13, 2021. The baby was born two days earlier at 22 weeks and at birth weighed just 1 lb., 0.1 oz.

Enlarge / A premature baby in the neonatal intensive care unit at University of Iowa Stead Family Children's Hospital in Iowa City, Iowa on August 13, 2021. The baby was born two days earlier at 22 weeks and at birth weighed just 1 lb., 0.1 oz. (credit: Getty | Michael S. Williamson/The Washington Post)

The Food and Drug Administration is warning health care providers not to use probiotics containing live bacteria or yeast in preterm infants after the agency began investigating the July death of a preterm, low-weight infant given such a product in an unnamed hospital.

The infant developed sepsis from the bacterium in the probiotic product—Evivo with MCT Oil made by Infinant Health—and subsequently died.

In a statement to Ars, the FDA said it quickly investigated the death after receiving an initial report on July 31. "Infant deaths are especially tragic and determining causality of preterm infant death can be particularly complicated," an agency spokesperson said. The agency reviewed medical records and laboratory tests from the case and collected clinical samples and product samples for analysis.

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