Tag: fda

One-Third Of New Drugs Had Safety Problems After FDA Approval

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a “black box” warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.

“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross says. The Yale researchers’ previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe does and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.

It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted “accelerated approval” and drugs that were approved near the regulatory deadline for approval.

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After failing to ban kratom domestically, the FDA is now pushing the UN and the WHO to ban it globally

The U.S. Food and Drug Administration (FDA) is on a mission to eliminate all consumer access to the herb mitragyna speciosa, also known as kratom – and your help is needed to stop it.

Back in 2016, the FDA tried, and was almost successful, at getting kratom banned here in the United States. The agency has long argued that kratom is a “dangerous drug” with no benefits that belongs on the Drug Enforcement Agency‘s (DEA) Schedule I list of prohibited substances.

Thanks to the diligent efforts of freedom fighters, the FDA was stopped in its tracks. Now, however, the agency is trying once again to eradicate the natural painkiller from existence – this time globally.

In a notice published in the Federal Register, the FDA is asking for feedback concerning its latest push to have the United Nations and the World Health Organization (WHO) add kratom and its constituents to the international schedule, which would prohibit kratom from being consumed anywhere in the world.

Until Aug. 9, 2021, the FDA is accepting public comments on the matter, which means your help is needed to let the agency know that it has no right trying to prohibit nature from being accessible to the people.

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FDA is set to announce new warning on J&J vaccine after 100 reports of it being linked to rare autoimmune disease Guillain-Barré syndrome

The U.S. Food and Drug Administration (FDA) is set to announce a new warning that the Johnson & Johnson COVID-19 vaccine is linked to a rare autoimmune disease.

Four people familiar with the situation told The Washington Post that the shot has caused instances of Guillain-Barré syndrome, a rare disorder in which the immune system attacks the peripheral nervous system, temporarily paralyzing parts of the body.

The Centers for Disease Control and Prevention (CDC) is said to have received about 100 preliminary reports of Guillain-Barré following the one-dose vaccine   

Most the cases have occurred about two weeks after vaccination and mostly in men aged 50 and older. 

With just 100 cases reported out of 12.8 million doses administered, this means the condition is very rare occurring in just 0.000781 percent of cases.

The warning is yet another setback for J&J’s vaccine, which has plagued by pauses, ingredient mix-ups and doses needing to be thrown out.

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FDA Document Reveals 86% of Children Who Participated in Pfizer COVID Vaccine Trial Experienced Adverse Reactions

A publicly available FDA “fact sheet” document reveals that 86% of children who participated in a Pfizer covid vaccine trial reported adverse reactions ranging from “mild” to “serious.”

As part of the vaccine experiments, children aged 12 to 15 are being injected with mRNA sequences that take control of their cells, causing them to churn our spike proteins in their blood. Spike proteins cause vascular disease and blood clots. Even the Jonas Salk Institute conclusively identifies spike proteins as the culprit behind vascular disease and blood clots.

This is all openly admitted by the FDA, which has published extremely disturbing reports of adverse reactions experienced by children in a Pfizer covid vaccine “fact sheet” labeled 144413. See the original FDA document here (PDF).

In case the FDA removes this sheet, we have archived it at Natural News servers here (PDF).

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FDA: ‘Vaccine hesitant’ can’t use antibody test to prove immunity!

Many Americans who have chosen not to get one of the experimental COVID-19 vaccines because of the risks have hoped that testing positive for antibodies could substitute for being vaccinated, providing a virtual “vaccine passport.”

But the Food and Drug Administration issued guidance this week stating a vaccine is still needed to confirm immunity from the COVID-19 virus.

The FDA acknowledged that antibody tests “can play an important role in identifying individuals who may have been exposed to the SARS-CoV-2 virus and may have developed an adaptive immune response.”

“However, antibody tests should not be used at this time to determine immunity or protection against COVID-19 at any time, and especially after a person has received a COVID-19 vaccination.”

The FDA said that antibodies provided by the vaccines are superior to the antibodies developed from being infected by the virus, providing needed protection that the regular antibodies do not.

But that’s contradicted by empirical study data, Yale University epidemiologist Dr. Harvey Risch told WND.

He pointed to a massive study in Israel finding that people who had tested positive for the novel coronavirus in the previous three or more months had at least as much protection against new infection, hospitalization and death as vaccinated people.

“People become immune by surviving infection,” argued Risch, professor of epidemiology in the Department of Epidemiology and Public Health at the Yale School of Public Health and Yale School of Medicine.

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Nearly Half of All NIAID and FDA Employees Are Refusing the COVID Vaccines That They’re Pushing on the Rest of Us

Roughly half of all National Institute of Allergy and Infectious Diseases (NIAID) and Food and Drug Administration (FDA) employees are refusing to take the COVID vaccines that they are pushing on the rest of us.

The FDA’s Peter Marks admitted that that 40-50 percent of CDC and FDA  employees have opted not to take the vaccine during an exchange with Sen. Richard Burr.

NIAID Director Anthony Fauci said the number is about the same for his agency.

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