Black box warning

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Health roundup: Herb bashing, black box warnings and Honey Nut Cheerios (satire) Mike Adams, the Health Ranger See article keywords and concepts

The matter is made worse by the "duh factor" fact that people diagnosed with ADHD or short attention spans probably don't have the concentration to read the black box warning in the first place. Not everyone knows what the "black box" refers to in these black box warnings, by the way. The answer is that the black box is a COFFIN. Better yet, it's the coffin in which you may find yourself if you continue to take drugs with black box warnings. There is no drug too dangerous for humans that it can't be excused by the FDA with a black box warning.

The FDA, Vioxx, and crimes against humanity Mike Adams, the Health Ranger See article keywords and concepts

Patients almost never see it. So a black box warning doesn't mean much anyway. FDA speak: equally dangerous = perfectly safe Even if it did mean something, there are some doctors who are trying to argue that a black box warning isn't needed. Why? They're saying that if Vioxx is shown to have no greater heart disease risk than other Cox-2 inhibitors, the black box warning should be removed. This is some really distorted, twisted logic here.

The Food-Mood Connection: Nutrition-based and Environmental Approaches to Mental Health and Physical Wellbeing Gary Null and Amy McDonald See book keywords and concepts

At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Too Profitable to Cure Brent Hoadley, Ph.D. See book keywords and concepts

The week of October 9, 2004, saw the FDA require a black box warning on all antidepressants. A very recent news article (2004), titled "FDA Accused of Silencing Vioxx Warnings,"7 by AP science writer Diedtra Henderson, adds further to the belief that those empowered do run interference and are complicit in keeping dangerous drugs in the marketplace. Dr. David Graham, associate director for science in the FDA, was quoted as saying he faced stiff resistance to reporting his findings regarding the increased dangers of heart disease and stroke associated with Vioxx.

The FDA, Vioxx, and crimes against humanity Mike Adams, the Health Ranger See article keywords and concepts

The only real regulatory action the FDA is taking on Vioxx, Bextra and other Cox-2 inhibitor drugs is the requirement of a black box warning on the drugs. This is supposed to be a big deal, but in fact it means little to nothing. This is just a bigger print size of the same warning that's been found in the small fine print of the drug for years. Doctors routinely ignore this information. Patients almost never see it. So a black box warning doesn't mean much anyway.

FDA speak: equally dangerous = perfectly safe Even if it did mean something, there are some doctors who are trying to argue that a black box warning isn't needed. Why? They're saying that if Vioxx is shown to have no greater heart disease risk than other Cox-2 inhibitors, the black box warning should be removed. This is some really distorted, twisted logic here.

They're saying that if all Cox-2 inhibitor drugs are equally dangerous and are equally responsible for killing tens of thousands of Americans, then none of them should carry a black box warning, because none of them are more dangerous than the other brand on the shelf next to them. So even though the whole class of drugs is extremely dangerous compared to herbal remedies or even relatively safe painkillers, some doctors want these black box warnings removed on the basis that, within this class of drugs, each one carries the same risk as the next.

The Big Fat Health and Fitness Lie Craig Pepin-Donat See book keywords and concepts

The FDA issued a "black box warning" label regarding Serzone in 2001, because of a suspected side effect that could cause life-threatening damage to the liver. How about Redux or Fen-Phen? Doctors reported an increase in heart valve failure resulting from the key ingredients of dexfenflu-ramine and fenfluramine in these "miracle diet drugs." Prior to its recall in 1997, the dream drug Fen-Phen turned into a nightmare for the 6 million people who had been using it and suddenly, had to worry about the damage that it had done to their hearts. Merck & Co., Inc.

The Food-Mood Connection: Nutrition-based and Environmental Approaches to Mental Health and Physical Wellbeing Gary Null and Amy McDonald See book keywords and concepts

Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months). The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality.

Human medical experiments go terribly wrong in "nightmare" TGN1412 drug trial Mike Adams, the Health Ranger See article keywords and concepts

Or maybe it will simply be approved with a black box warning. Drug companies around the world, of course, are now concerned they won't be able to sign up more human guinea pigs for their own experimental drug trials. The drug industry relies heavily on exploiting the poor as human guinea pigs (see Human medical experimentation in modern times: How immigrants, poor people, minorities and children are modern-day guinea pigs for Big Pharma ), for without poor people to run experiments on, there can be no official declaration that the drugs are safe enough for everyone else to take.

Hey, medheads! Here's the new language of the medication population (satire) Mike Adams, the Health Ranger See article keywords and concepts

Black boxer - A consumer who takes drugs that are so dangerous, the FDA requires the drug packaging to carry a large black box warning about severe harm or death. Black boxers usually don't care about the long-term harm to their health, they just want the pain (or other symptom) to go away so they can get back to watching prime-time television in relative comfort. Drug madvertising - The practice of allowing drug companies to advertise patented chemicals directly to consumers in order to create demand for drugs that everyday people frankly do not understand.

Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies Greg Critser See book keywords and concepts

The continued commercial availability, without a black box warning for [heart disease] patients, is indeed troubling." Troubling, yes. And for the hearts of the elderly, even more so. But Merck was silent. It was not until two months later, after it released its own study, that the company would act. The study had been concluded and its results known a year earlier: it showed a doubled risk of heart attack in a population of Vioxx users who were also at risk for colorectal polyps.

The China Study: The Most Comprehensive Study of Nutrition Ever Conducted and the Startling Implications for Diet, Weight Loss and Long-term Health T. Colin Campbell, Ph.D. and Thomas M. Campbell II See book keywords and concepts

A recent study found that one in five new drugs will either get a "black box warning," indicating a previously unknown serious adverse reaction that may result in death or serious injury, or will be withdrawn from the market within twenty-five years.32 Twenty percent of all new drugs have serious unknown side effects, and more than 100,000 Americans die every year from correctly taking their properly prescribed medication.33 This is one of the leading causes of death in America! DR. MCDOUGALL'S FATE When Dr.

Bitter Pills: Inside the Hazardous World of Legal Drugs Stephen Fried See book keywords and concepts

Technically, a black box warning (which most drugs do not have) is slightly less absolute than a contraindication, but it often has an equal if not stronger impact because of its prominent placement. As with contraindications, there are circumstances in which black box warnings may be reasonably disregarded by your doctor, after a careful assessment of the possible risks and benefits. However, even though the addition of a black box to an insert is often heralded by letters to physicians and coverage in the professional and lay press, don't assume that the news got to your doctor.

They now carry a black box warning for both these adverse drug reactions. A black box doesn't mean the medication should be avoided: in fact, gentamicin is still commonly used in hospitals. It simply means that the drug can be dangerous and patients taking it should be closely monitored. Drug companies apparently hate black boxes, especially for products like broad-spectrum antibiotics, which they want physicians to feel comfortable throwing at anything. A black box calls attention to a drug's risk/benefit ratio.

In my article, I called for a black box warning for CNS side effects to Floxin. I also urged the FDA to call a meeting of its Anti-Infectives Advisory Committee to put the drug's neurotoxicity on trial. The piece included as much of Diane's story as she and I felt was appropriate. The debates we had over the inclusion of personal details were intense. Since we had both written about each other before, we had already navigated some of this territory, but the stakes seemed much higher this time. And it's always easier to tell a personal story when you know how it ends, which we didn't.

I made my clarion call for a black box warning on the drugs, knowing I would probably have to settle for a "Contraindication"— which says the same thing, at the very top of the label, but not quite as loudly, and without the advertising restrictions—or perhaps a "Dear Doctor" letter, calling prescribers' attention to the neurotoxicities of the drugs. During my speech, I felt really stupid only once. That was when I mentioned the articles I had Xeroxed in advance for the committee, and I realized that one of the articles had been written by one of the committee members.

The company was somewhat reluctant to spend the money on a drug that had only a few years left on its patent and was certain not only to carry a black box warning but also to require regular blood monitoring. Several European countries were requiring patients on the drug to have blood tests weekly. In the United States there were many drugs that were labeled with suggestions that doctors do regular blood testing. But there had never been a successful drug, used outside of the hospital, that required patients to get their blood tested every week before receiving their next dose.

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ABOUT THE CREATOR OF NATURALPEDIA: Mike Adams, the creator of this NaturalNews Naturalpedia, is the editor of NaturalNews.com, the internet's top natural health news site, creator of the Honest Food Guide (www.HonestFoodGuide.org), a free downloadable consumer food guide based on natural health principles, author of Grocery Warning, The 7 Laws of Nutrition, Natural Health Solutions, and many other books available at www.TruthPublishing.com, creator of the earth-friendly EcoLEDs company (www.EcoLEDs.com) that manufactures energy-efficient LED lighting products, founder of Arial Software (www.ArialSoftware.com), a permission e-mail technology company, creator of the CounterThink Cartoon series (www.NaturalNews.com/index-cartoons.html) and author of over 1,500 articles, interviews, special reports and reference guides available at www.NaturalNews.com. Adams' personal philosophy and health statistics are available at www.HealthRanger.org.