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    Conservative judges revive case on FDA’s “you are not a horse” ivermectin posts / ArsTechnica · Tuesday, 5 September - 22:54

Tablets of ivermectin.

Enlarge / Tablets of ivermectin. (credit: Getty | Nurphoto )

A panel of conservative judges has revived a lawsuit over the Food and Drug Administration's statements about the anti-parasitic and de-worming drug ivermectin—statements meant to clarify that the drug is not effective against COVID-19 and that formulations for animals, including livestock, are not safe for use in humans .

After the FDA received reports of people being hospitalized from taking livestock ivermectin , one of the agency's particularly viral posts began: " You are not a horse ."

The lawsuit over the posts comes from three doctors, all of whom have faced charges and/or discipline from their respective state medical boards and employers over the ivermectin prescribing. The disgraced trio argue that the FDA's statements interfered with their ability to prescribe the antiparasitic drug to COVID-19 patients—including some patients the doctors had never actually examined , according to allegations by state medical boards.

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    FDA issues safety alert on pregnancy tests after bust on illegal medical lab / ArsTechnica · Tuesday, 15 August - 22:42 · 1 minute

A picture of containers taken from the illegal UMI lab in Reedley, California.

Enlarge / A picture of containers taken from the illegal UMI lab in Reedley, California. (credit: FCDPH )

The Food and Drug Administration is warning consumers not to use any at-home tests made by Universal Meditech, Inc. (UMI), the company behind an illegal medical lab hidden in a warehouse in the small city of Reedley, California. The lab was shut down earlier this year by local, state, and federal agencies, which are still working to clear the site, properly dispose of all its hazardous contents, and investigate those responsible.

"UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests," the FDA said in a safety communication Friday . "The FDA is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe and effective."

UMI manufactured a variety of strip-based tests, mostly pregnancy tests, but also tests for ovulation, ketones, and alcohol in breast milk. The tests were sold under several names—including DiagnosUS, HealthyWiser, DeTec, and PrestiBio. They were available online from at least four distributors, which may not have identified UMI as the manufacturer. The known distributors are: AC&C Distribution, LLC; HealthyWiser; Home Health US Inc.; and Prestige Biotech Inc. The FDA cautions that there may be other distributors that it doesn't know about.

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    New SARS-CoV-2 variant gains dominance in US amid mild summer COVID wave / ArsTechnica · Monday, 7 August - 22:21

New SARS-CoV-2 variant gains dominance in US amid mild summer COVID wave

Enlarge (credit: Getty | Thomas Trutschel )

For a fourth consecutive summer, COVID-19 is on the rise, though this year's warm-weather wave appears milder than those in the emergency period of the pandemic.

COVID-19 indicators of hospital admissions, emergency department visits, test positivity, and wastewater levels have all been increasing in the past month, with a peak not yet clearly in sight, according to data tracking by the Centers for Disease Control and Prevention. From June 10 to July 29, test positivity rose from 4.1 percent to 8.9 percent. For reference, the most recent winter wave had a peak test positivity of 10.6 percent on December 31, 2022.

On the brighter side, however, weekly COVID-19 hospital admissions and deaths continue to be at their lowest points since the start of the pandemic. For now, deaths do not appear to be rising, though there are lags in data reporting. Weekly new hospital admissions are ticking up only slightly—with admissions rising to about 8,000 in the week of July 22, up from around 6,300 the week of June 24.

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    This company keeps selling TB-tainted bone grafts, causing deadly outbreaks / ArsTechnica · Friday, 28 July - 20:01

Scanning electron micrograph of <em>Mycobacterium tuberculosis</em> bacteria, which cause TB.

Scanning electron micrograph of Mycobacterium tuberculosis bacteria, which cause TB. (credit: National Institute of Allergy and Infectious Diseases )

For the second time, contaminated bone graft products from the medical company Aziyo Biologics Inc. are linked to a highly unusual and deadly outbreak of tuberculosis .

This week, three new tuberculosis cases were identified, bringing the outbreak total to five, according to Politico . One person has died. The contaminated material, used for surgical and dental procedures, was implanted in at least 36 other patients, who are now being treated as if they have tuberculosis.

Aziyo Biologics issued a recall of all of its bone matrix products earlier this month "out of an abundance of caution" after the first two cases were identified. The Centers for Disease Control and Prevention reports that all unused products from the affected lot have been sequestered so that they will not be used. The affected materials had been sent to health care facilities in California, Michigan, New York, Oregon, Texas, and Virginia.

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    FDA advisers vote unanimously in favor of OTC birth control pills / ArsTechnica · Wednesday, 10 May - 20:00

FDA advisers vote unanimously in favor of OTC birth control pills

Enlarge (credit: Perrigo)

A panel of independent medical experts for the Food and Drug Administration voted unanimously on Wednesday in favor of allowing the hormonal birth control pill Opill (norgestrel) to be sold over the counter rather than by prescription.

The 17-0 vote by the panel came after a two-day meeting in which they reviewed data and analysis from the pill's maker, Laboratoire HRA Pharma, and FDA scientists, as well as public comments on the potential switch.

Opill is a once-a-day pill containing only progestin. It was first approved in 1973 and has proven remarkably safe in the five decades since then, proving safer than combination hormone pills that have risks of blood clots. Experts estimate Opill is about 93 percent effective at preventing pregnancy in real-life use, higher than the real-life efficacy of other easily accessible birth-control methods, such as condoms (around 87 percent).

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    Healthy adults don’t need annual COVID boosters, WHO advisors say / ArsTechnica · Tuesday, 28 March, 2023 - 22:11 · 1 minute

A vial containing Moderna COVID-19 booster vaccine at a vaccination center.

Enlarge / A vial containing Moderna COVID-19 booster vaccine at a vaccination center. (credit: Getty | SOPA Images )

A vaccine advisory group for the World Health Organization said Tuesday that, at this point, it does not recommend additional, let alone annual COVID-19 booster shots for people at low to medium risk of severe disease. It advised countries to focus on boosting those at high risk—including older people, pregnant people, and those with underlying medical conditions—every six to 12 months for the near- to mid-term.

The new advice contrasts with proposed plans by US Food and Drug Administration , which has suggested treating COVID-19 boosters like annual flu shots for the foreseeable future. That is, agency officials have floated the idea of offering updated formulations each fall, possibly to everyone, including the young and healthy.

In a viewpoint published last May in JAMA , the FDA's top vaccine regulator, Peter Marks, along with FDA Commissioner Robert Califf and Principal Deputy Commissioner Janet Woodcock, argued that annual COVID booster campaigns in the fall, ahead of winter waves of respiratory infections—such as flu, COVID-19, and RSV—would protect health care systems from becoming overwhelmed. And they specifically addressed the possibility of vaccinating those at low risk.

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    Two more dead as patients report horrifying details of eye drop outbreak / ArsTechnica · Friday, 24 March, 2023 - 21:11 · 1 minute

Young man applying eye drops.

Enlarge (credit: Getty | UniversalImagesGroup )

Two more people have died and more details of horrifying eye infections are emerging in a nationwide outbreak linked to recalled eye drops from EzriCare and Delsam .

The death toll now stands at three, according to an outbreak update this week from the Centers for Disease Control and Prevention. A total of 68 people in 16 states have been infected with a rare, extensively drug-resistant Pseudomonas aeruginosa strain linked to the eye drops. In addition to the deaths, eight people have reported vision loss and four have had their eyeballs surgically removed (enucleation).

In a case report published this week in JAMA Ophthalmology, eye doctors at the Bascom Palmer Eye Institute, part of the University of Miami Health System, reported details of one case linked to the outbreak—a case in a 72-year-old man who has an ongoing infection in his right eye with vision loss, despite weeks of treatment with multiple antibiotics. When the man first sought treatment he reported pain in his right eye, which only had the ability to detect motion at the point, while his left eye had 20/20 vision. Doctors noted that the white of his right eye was entirely red and white blood cells had visibly pooled on his cornea and in the front inner chamber of his eye.

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    68 now sickened, 4 lose eyeballs in outbreak linked to eyedrops / ArsTechnica · Thursday, 16 March, 2023 - 12:18

68 now sickened, 4 lose eyeballs in outbreak linked to eyedrops

Enlarge (credit: Getty | Maciej Luczniewski )

An alarming outbreak of extensively drug-resistant bacteria linked to eye drops has now sickened 68 people across 16 states, according to the latest update from the Centers for Disease Control and Prevention . At least 16 people have been hospitalized, eight have lost vision, and four have had their eyeballs surgically removed (enucleation). One person has died, which was reported earlier.

The agency first released a health alert on the outbreak February 1. At that point, the outbreak had sickened 55 people in 12 states, with the one death reported in a Washington patient. In an update emailed to Ars on February 22, the CDC said the case count had reached 58, with five cases of vision loss and one enucleation.

The continued rise in cases and severe outcomes highlights the challenge of fighting the germ behind the outbreak, which is an extensively drug-resistant form of Pseudomonas aeruginosa . It has the unwieldy name of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa—or VIM-GES-CRPA, for short.

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