Posted on 11/11/2021 5:12:19 AM PST by Mount Athos
Almost one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected, sometimes life-threatening side effects or complications, a new analysis found.
The results covered all 222 prescription drugs approved by the U.S. Food and Drug Administration from 2001 through 2010. The researchers looked at potential problems that cropped up during routine monitoring that's done once a medicine is on the market.
The 71 flagged drugs included top-sellers for treating depression, arthritis, infections and blood clots. Safety issues included risks for serious skin reactions, liver damage, cancer and even death.
"The large percentage of problems was a surprise," and they included side effects not seen during the review process, said Dr. Joseph Ross, the study's lead author and an associate professor of medicine and public health at Yale University.
While most safety concerns were not serious enough to prompt recalls, the findings raise questions about how thoroughly drugs are tested before approval, said drug safety expert Thomas Moore. But Ross said the results suggest that the FDA "is kind of doing a great job" at scrutinizing drugs after approval.
New drugs are generally tested first in hundreds or even thousands of people for safety and effectiveness.
"We know that safety concerns, new ones, are going to be identified once a drug is used in a wider population. That's just how it is," Ross said. "The fact that that's such a high number means the FDA is working hard to evaluate drugs and once concerns are identified, they're communicating them."
The researchers analyzed online FDA data on new drugs and the agency's later safety announcements. Problems surfaced on average about four years after approval. Results were published Tuesday in the Journal of the American Medical Association.
The FDA said in a statement that it performs post-market monitoring "to identify new safety information that may impact product labeling." The agency said it would review the study findings but declined to comment further.
"We know that safety concerns, new ones, are going to be identified once a drug is used in a wider population."
The study counted black-box warnings for dozens of drugs; these involved serious problems including deaths or life-threatening conditions linked with the drugs. There were also dozens of alerts for less serious potential harms and three drug withdrawals because of the potential for death or other serious harm.
Among the drugs with added warnings: Humira, used for arthritis and some other illnesses; Abilify, used for depression and other mental illness; and Pradaxa, a blood thinner. The withdrawn drugs and the reason: Bextra, an anti-inflammatory medicine, heart problems; Raptiva, a psoriasis drug, rare nervous system illness; and Zelnorm, a bowel illness drug, heart problems.
Safety issues were most common for psychiatric drugs and biologic drugs - made from living cells rather than chemicals - than for older drug types. Drugs brought to market through "accelerated" approval were slightly more likely to have later safety issues than those approved through conventional channels, a link seen in some previous research.
In recent years, there has been increasing pressure on the FDA from consumers and others to speed up its regulatory review process to get new drugs to the market sooner, Ross said.
Moore, a senior scientist for drug safety and policy at the Institute for Safe Medication Practices, said the new results raise concerns about whether new drugs are being extensively tested before approval. He noted that since 2011, drugs have increasingly been approved based on studies in small numbers of patients amid public criticism questioning whether the FDA is keeping potential cures away from patients.
"The answer is, you can't know whether they're valuable and lifesaving treatments unless you test them" adequately, Moore said.
PhRMA, a drug industry trade group, is reviewing the study, said spokeswoman Holly Campbell. In a statement, she said the industry is committed to post-market surveillance of new medicines, but added, "Even with rigorous clinical studies and regulatory review it may be impossible to detect certain safety signals until several years after approval, once the medicine is in broader use."
How shocked would they be if they have bad effects from it months or years later?
Why would they assume it is unlikely, when NONE of the covid vaccines have undergone long term testing?
What does science say about long term effects? Absolutely nothing. No science has been done on the long term effects.
People are participating in a huge experiment.
The numbers of people who die because of covid have been wildly overestimted. Note the Italian study that found only 4k of 135k claimed covid deaths were really attributable to covid.
The numbers of vaccine injuries are wildly underestimated. Lots go unreported. Doctors don't know about the system, don't know how to use it, don't have time. Hospitals actively discourage reporting.
They are now pushing this vaccine hard on children 5-12 years old, despiting having no legitimte risk from covid. All of the recorded deaths in this range have major comorbidities. This should tell you that the motives of the vaccine industrial complex are utterly corrupted. Children much younger than 5 are currently being tested, approval is in the works.
Wonder why NBC is publishing this, as it borders on heresy in that it may be used by us heretics against the unholy narrative.
I too wonder WHY NBC is reporting this.
One thing I have learned - there is an agenda behind every story that gets printed. Every story, no matter how small.
it’s from 2017
Thalidomide was given to pregnant women in Germany for 5 years.
Oops.
On the other hand If i want to exercise my “right to try” (ivermectin, or hydroxychloroquine, or sheep dip!) on a drug with a decades long record …. the PTB say I can’t do that?
To say... see other drugs cause side affects. Covid Vaccine no different.
“Suprise”, your dead.
Every story, no matter how small.
************
Does every post have an agenda no matter how small? Just
bringing a tidbit to the fore front from a few years back.
My experience is that hospitals encorage reporting of any adverse drug reaction. Even if it is a well known one.
The reality is that the process is so cumbersome and the invitation for scrutiny of all involved leads to underreporting.Workers have little time to sit down and fill out the forms(some computer aided forms are WORSE than filling out paper forms)
But the eventual discovery that approved drugs have long term effects not elucidated during approval process really is not a new thing. Anybody with half a brain who works in the field longer than five years already knows it.
NBC doesn’t see the connection between this story and the covid shot???
Link to study:
https://jamanetwork.com/journals/jama/fullarticle/2625319
Every time my doctor prescribes a new drug for me, I get online and look at it’s possible side effects. Usually between 20 and 40.
I suppose every post does have an agenda.
Sometimes the agenda of a post is to make others think about an issue a little more.
Sometimes the agenda of a post is to make others laugh.
Sometimes the agenda of a post is to piss off others.
Sometimes the agenda of a post is to simply share one’s own opinion.
So yes, every post does have an agenda.
Yep, gotta be careful with them AGENDAS.
Don’t let them bite you. Now you have a
blessed AGENDA DAY.
New Drugs and Years After Approval ? What
“The number of vaccine injuries are wildly underestimated. Lots go unreported.”
I have been speculating on this for some time. Is it possible that there are perverse incentives not to report vaccine injuries? Obviously doctors and hospitals wouldn’t want to report them unless the connection between the vaccine and the injury were absolutely unimpeachable, but does health and life insurance policies also incentivize victims and/or their survivors to “don’t ask, don’t tell”? Is the vaccine, at least prior to FDA approval, considered an experimental treatment which insurance might not cover?
And Bendectin here
Ooops
Canada also.
Vacationed there in the mid 60's. Saw plenty of pictures in newspapers of children missing and deformed limbs.
at this point news staff are looking at forcible vaccination of their own kids. they cannot spell it out, of course, but articles like this might slip through from time to time.
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