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Quotes about Black Box warning from the world's top natural health / natural living authors

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"Johann-Liang had called for a black box warning on the drug, FDA Commissioner von Eschenbach capitulated, announcing that black box warnings would be included on Avandia labels.105 In July of 2007 the FDA convened a drug advisory committee meeting at which FDA's Dr. David J. Graham spoke. Graham recommended that Avandia be removed from the market. Pressured to keep the product on the market despite the heart risks, the committee produced a schizophrenic result." - Jonathan W. Emord, The Rise of Tyranny (Get the book.) "Rosemary Johann-Liang, advocated a black box warning to inform physicians and patients of the drugs risks to the heart.100 Her recommendation was also ignored, and she was then subjected to managerial pressure.101 Johann-Liang's supervisor, Dr. Mark Avigan, told her that agency management was "upset with [her] recommendation" and "decided to act like the review never happened."102 On May 21, 2007, the New England Journal of Medicine published a meta-analysis by Drs. Stephen Nissen and Kathy Wolski finding Avandia increased the risk of heart attack by 43%." - Jonathan W. Emord, The Rise of Tyranny (Get the book.) "On September 14, 2004, FDA's advisory committee voted 18 to 5 to require manufacturers of antidepressants to include the following black box warning on those products: Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Drug Name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need." - Jonathan W. Emord, The Rise of Tyranny (Get the book.)

"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." - Gary Null and Amy McDonald, The Food-Mood Connection: Nutrition-based and Environmental Approaches to Mental Health and Physical Wellbeing (Get the book.) "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." - Gary Null and Amy McDonald, The Food-Mood Connection: Nutrition-based and Environmental Approaches to Mental Health and Physical Wellbeing (Get the book.)

"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." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.)

"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." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.)

"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." - Brent Hoadley, Ph.D., Too Profitable to Cure (Get the book.)

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

"Projections based on the pace of these events suggested that one in five approved drugs would eventually either receive a black box warning or be withdrawn. The authors of the analysis, from Harvard Medical School and Public Citizen Health Research Group, suggested that the FDA should raise the bar for approval of new drugs when safe and effective treatments are already available or when the drug is for a non-life-threatening condition." - Richard A. Deyo M.D. M.P.H., Donald L. Patrick, Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises (Get the book.) "A recent study in the Journal of the American Medical Association estimated that one out of five new drugs will eventually be withdrawn from the market or receive a so-called black box warning of serious potential side effects—risks that were unknown when the drug was first marketed.41 As a well-informed, critically thinking health-care researcher, I (Donald) waited many years for rigorous evidence on statin drug treatment for cholesterol, and then tried statins in order of their effectiveness and price." - Richard A. Deyo M.D. M.P.H., Donald L. Patrick, Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises (Get the book.)

"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." - Stephen Fried, Bitter Pills: Inside the Hazardous World of Legal Drugs (Get the book.)

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