Tag: fda

Liver Injuries Reportedly on the Rise: Common, FDA-Approved Meds Linked to Alarming Trend

As more people find themselves using more vitamins, supplements, and everyday medications, more related health issues keep cropping up.

And a recent spate of reports highlights a particular danger for one part of your body: the liver.

“As cases of drug-induced liver injury (DILI) are on the rise, experts are warning of the hidden dangers associated with some common medications and supplements,” Fox News reported Monday.

The outlet added, “Statistics show that DILI, also known as toxic hepatitis or hepatotoxicity — which is known to be a significant cause of acute liver failure — has been growing in Western countries since the 1960s.”

“Even medications that have been tested for safety and approved by the U.S. Food and Drug Administration (FDA) can potentially cause liver injury in rare cases,” Fox reported.

Just days earlier, on May 27, NBC News had posted a similarly alarming report regarding these health ramifications.

The outlet spoke to Robert Grafton, a former medical technologist who noticed signs of liver failure in himself and largely traced it back to various supplements and vitamins he had been taking.

“I stopped taking everything, thank goodness,” Grafton said. “If I hadn’t known, if I was not in the medical field, I might have thought, ‘Oh, I think I’m getting sick. I need to take some more of these supplements to help me feel better.’”

Despite stopping, symptoms worsened and test results pointed toward devastating liver failure.

It turned out to be a case of DILI.

“It is estimated that between 13.9 and 19.1 cases of DILI occur for every 100,000 people, according to recent research published in the journal Toxicology Reports,” Fox noted.

The triggers of DILI can vary, from the vitamins and supplements that Grafton had been taking, mentioned above, to aspirin, the common over-the-counter painkiller.

Those with health conditions are more susceptible to DILI, but as Grafton — someone who began taking his health seriously after having children — shows, it can hit very healthy people, too.

Fox News medical analyst Dr. Marc Siegel told his network that the unregulated nature of supplements could betray some of their purported health benefits.

“The biggest problem with herbal supplements is that the amount you are taking of active chemicals isn’t strictly regulated, so you don’t know exactly what you are getting,” he said. “And since several of the supplements are metabolized through the liver, there is now an increasing incidence of liver toxicity in users.”

According to the National Institutes of Health, “nearly all classes of medications” can cause DILI.

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An Evidence-Based Approach to Covid-19 Vaccination??

‘An Evidence-Based Approach to Covid-19 Vaccination’ is the misleading title of an extraordinary publication by Vinay Prasad and Marty Makary in the New England Journal of Medicine, 20th May 2025. It describes the FDA’s new approach, but if you were hoping for ‘Evidence-Based’ you’ll be sorely disappointed. One could argue that this is a start, in that it does involve withdrawing FDA recommendations for regular boosters for ‘healthy 6 months- to 64 year-olds’ but the state of ‘health’ in the US is so poor that apparently two thirds of Americans are still eligible for the shots. (‘Underlying medical conditions’ include pregnancy, obesity, physical inactivity and smoking, current and former),

The article goes on to describe a requirement for gold standard randomised controlled trials for further vaccines for a healthy population of say 50-64 years with a saline placebo and a 6 month follow-up but again using an end-point related to covid alone rather than all-cause mortality or morbidity. For over-65s or those with comorbidities, only evidence of antibody production is required.

Then on 27th May, a week after the NEJM article, Robert Kennedy, flanked by Jay Battacharia and Marty Makary, announced the changes to the CDC schedule, stating that the vaccines would be withdrawn for healthy under 65s and healthy pregnant women. The statement was somewhat underwhelming, especially Jay Battacharya’s rather wooden performance – another example of the 3-word or 3-phrase mantra: “That ends today. It’s common sense and it’s good science”.

Some cynics were quick to point out that the CDC guidance had not changed, but by 29th May the website was updated though not in quite the way I had anticipated from RFK’s words. The covid vaccine for children now states ‘See notes’ and then outlines a system of ‘shared clinical decision-making’ as follows: “Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances.” Only for children with moderate or severe immunocompromise does the CDC actively advise a booster. So for children this actually goes further than the Prasad and Makary article, leaving only immunocompromise as a co-morbidity for recommended covid boosters in under 18s, in line with the current UK guidelines. The Children’s Health Defence have tried to explain the very opaque guidelines – one plus would be that paediatricians would no longer be obliged to recommend the vaccines – at present they risk losing their tenure if they speak out against the jabs. But for adults, there appears to be no change with covid vaccines still recommended as routine including during pregnancy.

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FDA Launches New AI Tool

The Food and Drug Administration on June 2 launched a new artificial intelligence (AI) tool.

FDA officials said Elsa, the tool, will help employees “work more efficiently.”

The agency is utilizing Elsa to speed up clinical protocol reviews and scientific evaluations, as well as to identify targets for inspections.

FDA officials described Elsa as a “large language model–powered AI tool designed to assist with reading, writing, and summarizing.” They said it can summarize adverse events to help with safety profile assessments, compare labels faster than humans, and generate code to help develop databases.

“Today marks the dawn of the AI era at the FDA with the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,” FDA Chief AI Officer Jeremy Walsh said in a statement.

AI refers to computer systems that perform complex tasks typically performed by humans.

Dr. Marty Makary, the FDA’s commissioner, said in May that the FDA would immediately start using AI and fully integrate it by the end of June.

“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” Makary said on Monday.

“Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”

Health Secretary Robert F. Kennedy Jr., who leads the Department of Health and Human Services (HHS), the FDA’s parent agency, cheered the development, calling it “a revolution in public health” in a post on social media platform X.

The FDA recently fired thousands of employees. HHS officials had said they would cut about 3,500 full-time workers but ended up terminating about 2,500 workers, according to a Senate Democrat report.

Makary told a congressional panel during a recent appearance that no scientific reviewers were fired, although some research scientists were among those terminated.

President Donald Trump has promoted the use of AI, saying in one order that “with the right Government policies, we can solidify our position as the global leader in AI and secure a brighter future for all Americans.”

The first report from Trump’s Make America Healthy Again (MAHA) Commission, headed by Kennedy, contained markers of AI, including nonexistent studies and multiple instances of “oaicite,” which developers say is inserted by OpenAI’s ChatGPT AI tool.

“The pattern is consistent with other cases we’ve seen of using generative AI to create citations,” Dr. Ivan Oransky, co-founder of Retraction Watch and executive director of The Center for Scientific Integrity, told The Epoch Times in an email.

“The fact that these fake citations made it into the report are evidence that no one checked the report for rigor. That should concern anyone who reads it or considers relying on it.”

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FDA approves Moderna’s new lower-dose COVID-19 vaccine

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company’s existing shot, but a second option.

The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It’s made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax — by refining its immune target.

The approval “adds an important new tool to help protect people at high risk of severe disease from COVID-19,” Stephane Bancel, Moderna’s CEO, said in a statement Saturday.

The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus.

That’s the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax.

Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials.

Moderna’s existing vaccine doesn’t face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall.

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Moderna Pulls Application for FDA Approval of Flu-COVID Shot After FDA Calls for New Clinical Trials

Moderna is withdrawing its application for U.S. Food and Drug Administration (FDA) approval of its mRNA-1083 combination flu and COVID-19 vaccine, the company announced today — just one day after the FDA said it would require new clinical trials to approve COVID-19 boosters for healthy people under 65.

According to Fierce Biotech, the company will resubmit its application when data from a Phase 3 trial of its mRNA-1010 flu vaccine, which is a component of the combined shot, are available later this year. The company expects to have interim data from the trial available this summer.

Markets reacted negatively to the news, with Moderna’s shares falling 1.4% in premarket trading on Wednesday, The Guardian reported.

According to Reuters, Moderna’s decision to withdraw its application at this time “is the latest sign of increased regulatory scrutiny of the vaccine approval process since Robert F. Kennedy Jr. took the top U.S. health job earlier this year.”

Last week, for instance, the FDA approved Novavax’s new COVID-19 vaccine, but limited its approval to groups that are considered high-risk.

Sayer Ji, co-founder of Stand for Health Freedom and founder and director of GreenMedInfo, said Moderna’s decision to withdraw its application is “telling” and “appears to reflect not only concerns over efficacy but also a growing public skepticism toward hastily developed, multi-antigen formulations that lack sufficient long-term safety data.”

Ji said:

“The withdrawal may be a preemptive move to avoid public scrutiny or regulatory resistance tied to unresolved questions in their clinical data. Combination shots, especially those involving mRNA platforms, introduce compounded risks due to the simultaneous delivery of multiple immunogenic agents.

“These risks are poorly understood and grossly under-evaluated, particularly in vulnerable populations. The immunological complexity of such a vaccine also raises questions about long-term impacts on immune regulation, potential autoimmunity and unintended synergistic effects that could compromise health rather than protect it.”

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FDA Forces Moderna and Pfizer to Admit Covid “Vaccines” Cause Lasting Heart Damage in Young Males

For years, parents and medical professionals have sounded the alarm about the dangerous link between mRNA COVID-19 vaccines and heart inflammation in young males—only to be dismissed as “anti-vaxxers” or conspiracy theorists. Now, in a stunning reversal, the U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to strengthen their warning labels, finally admitting that these shots can cause long-lasting heart damage, particularly in adolescent boys and young men.

But this admission comes far too late—after millions of doses were administered under false pretenses, after countless young lives were altered by myocarditis, and after public health agencies actively suppressed the truth. The FDA’s belated action raises a critical question: How many more injuries could have been prevented if the government had prioritized transparency over blind vaccine promotion?

Key points:

  • The FDA has mandated that Pfizer and Moderna update their COVID-19 vaccine labels to include stronger warnings about myocarditis and pericarditis, particularly in males aged 16 to 25.
  • New data reveals that myocardial injury is often long-lasting, contradicting earlier CDC claims that heart inflammation “tends to resolve quickly.”
  • The highest incidence of myocarditis occurs in young males, with 38 cases per million doses—far higher than previously acknowledged.
  • Internal government emails show that health officials deliberately avoided warning the public about these risks, even after detecting safety signals in 2021.
  • The FDA’s action follows a Senate investigation exposing how federal agencies downplayed and hid vaccine injuries.

A long-overdue admission of harm

For years, independent researchers and medical professionals warned that mRNA vaccines posed a disproportionate risk to young, healthy individuals—especially males. Yet, public health agencies dismissed these concerns, insisting that the benefits outweighed the risks. Now, the FDA has been forced to acknowledge what health freedom fighters have said all along: These vaccines can cause serious, sometimes permanent, heart damage.

The updated labels must now state that myocardial injury is common among those who develop post-vaccination myocarditis, with data showing persistent damage five months after vaccination. This directly contradicts the CDC’s previous assurances that cases were “mild” and “resolved quickly.”

Why did it take so long? Internal documents obtained through FOIA requests reveal that as early as May 2021, the CDC and FDA considered issuing a public warning but ultimately chose silence over transparency.

The suppression of truth and the cost of deception

The Senate’s Permanent Subcommittee on Investigations recently released a damning report exposing how federal health agencies systematically concealed the myocarditis risk linked to COVID-19 vaccines. Internal emails reveal that officials engaged in a coordinated cover-up by refusing to update the V-safe reporting system to include cardiac symptoms, ensuring countless cases were never documented. Additionally, they blocked a planned Health Alert Network warning that would have alerted doctors and the public to the dangers, prioritizing public perception over transparency.

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Dr. McCullough Drops the Hammer in the Senate — FDA Concedes with Expanded Myocarditis Warning

“When a product causes death, that demands a black box warning — immediately.”

That was the clear and urgent message from Dr. Peter McCullough, testifying before the Senate Homeland Security and Governmental Affairs Committee this week at a hearing titled: “The Corruption of Science and Federal Health Agencies: How Health Officials Downplayed and Hid Myocarditis and Other Adverse Events Associated with the COVID-19 Vaccines.”

Dr. McCullough presented data from both his clinical experience and the peer-reviewed literature, exposing the widespread risks of COVID-19 mRNA injections — particularly myocarditis in young men and fatal vaccine outcomes confirmed by autopsy.

“I’ve examined thousands of patients with this problem,” he told the Senate. “Before the pandemic, I had seen just two cases in my entire career.”

Just one day before the hearing, likely for preemptive damage control purposes, the FDA quietly updated its myocarditis warning on Pfizer and Moderna’s COVID-19 vaccines, expanding the risk category to males aged 16 to 25 and citing an incidence of 8 cases per million doses for the 2023–2024 formulations. Unfortunately, no mention of death was added — despite robust, peer-reviewed autopsy evidence confirming fatal vaccine-induced myocarditis.

Dr. McCullough referenced multiple such cases, including the tragic findings of Gill et al, who documented two teenage boys (ages 16 and 17) found dead at home just days after receiving the Pfizer vaccine. Autopsies confirmed unequivocal myocarditis as the cause of death.

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FDA Directs COVID-19 Vaccine Makers to Expand Heart Inflammation Warning

The Food and Drug Administration (FDA) has directed COVID-19 vaccine manufacturers to expand the warning for two forms of inflammation, according to letters made public on May 21.

The FDA told BioNTech, which produces a vaccine with Pfizer, and Moderna to update warnings regarding myocarditis—or heart inflammation—and the related condition pericarditis.

Richard Forshee, acting director of the FDA’s Office of Biostatistics and Pharmacovigilance, said that new information has emerged, including a 2024 FDA study that found that some myocarditis patients had signs of heart scarring months after vaccination.

The companies must update labels to state that following administration of the 2023–2024 versions of the vaccines, “the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age,” Forshee said. The highest estimated incidence of the post-vaccination inflammation is about 38 cases per million doses for both vaccines, according to the proposed update.

The current warnings say that the highest observed risk after Moderna vaccination is in males aged 18 to 24 and that the highest risk after Pfizer-BioNTech vaccination is in males aged 12 to 17.

The companies were also directed to add new information summarizing the FDA study, including that “at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common.” The updates should also state that “it is not known if these heart MRI findings might predict long-term heart effects of myocarditis,” according to the letters.

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The First Step on the Covid Shots

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is holding a very important meeting on May 22, 2025. Under consideration at this meeting is the fate of the Covid booster shots. There has been considerable anticipation as well as media claims that current recommendations and authorization for these products’ use, particularly in children and pregnant women, may be discontinued. 

Public comments are currently being solicited for the meeting, and wide public interest surrounds this event. Unfortunately, I have received reports from colleagues that some comments submitted to the committee calling for discontinuation of these vaccines have disappeared from the FDA website.

Furthermore, an important article from the FDA published today in the New England Journal of Medicine acknowledges the huge discrepancies in Covid vaccine recommendations in the US vs. other countries – as I describe in detail below. The article hints yet again at possible changes in official recommendations regarding the Covid vaccines. In terms of actual changes, however, none have yet been made official 

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FDA plans to require clinical trials before approving annual COVID vax boosters for healthy people

Food and Drug Administration plans to require new clinical trials before approving annual COVID-19 vaccine boosters for healthy Americans under 65 years old.

The plan appears in a paper published Tuesday in the New England Journal of Medicine, in which FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the FDA’s vaccine chief, wrote any new COVID shot must undergo placebo-controlled clinical trials, NBC News reported. 

This means that the release of updated COVID vaccines for healthy children and adults this fall will likely be delayed.

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