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FDA Finally Admits Popular Antibiotic May Be Dangerous & Deadly. What To Watch Out For

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Antibiotics are life savers. But like all drugs, they have side effects, and some may be dangerous and deadly. This is especially true with a class of drugs called fluoroquinolones that include Levaquin, Cipro, and Avelox.

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Over 33 million Americans take one or more of these antibiotics each year, and in 2010, Levaquin was the bestselling antibiotic in the country. There’s a good chance that you or a family member has taken one of these potentially harmful drugs within the last year.

Serious questions have been raised about the safety of these medications, most notably Levaquin, since their marketing in 1996. Until recently, the FDA did little to warn doctors and consumers of the possible deadly side-effects. By 2010, Levaquin was involved in over 3,400 lawsuits and possibly 5,000 deaths.

Dangerous Side Effects

According to The Daily Beast:

levaquinWarnings surrounding the popular antibiotic Levaquin have been dangerously insufficient. The drug, capable of causing debilitating tendinitis, permanent nerve damage, and even psychosis, is meant to be reserved for severe life-threatening infections.

Unfortunately, many doctors are prescribing fluoroquinolones like Levaquin for non-life threatening conditions such as earaches, bronchitis, sinusitis, and other ailments which could be allowed to resolve on their own or are easily treated with lesser drugs or non-drug remedies. This has led to bacterial resistance and serious, possibly life-threatening side-effects in people who should not be taking the drug for less severe conditions.

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Thousands of people have reported ill effects from taking Levaquin and have chronicled the adverse effects of this class of drugs, which include paralysis, excruciating joint pain, tendon ruptures, difficulty breathing, exhaustion, neurological damage, dizziness, depression, anxiety, etc.

Here are some typical comments from Levaquin users who experienced adverse effects:

From Askapatient.com: “Took one pill- then could not walk for months- Was in a wheelchair – extreme pain.”

From Drugs.com “I was a healthy, active college student minoring in dance when I took this for a sinus infection. After a few pills it completely destroyed my life…No more than hour of sleep for over a year due to neurological damage that destroyed my sleep cycle.”

From Askapatient.com“worst stuff I have ever used ended up in the er was so scared, it killed me with back and knee pain could not get out of bed without screaming, never again!”

In 2012, Jane Brody of the New York Times interviewed Dr. Mahyar Etminan, a pharmacological epidemiologist who researched the effects of fluoroquinolones. He found “that the risk of suffering potentially blinding retinal detachment was nearly fivefold higher among current users of fluoroquinolones . . . and [there was] a significantly increased risk of acute kidney failure.”

Dissection and Aneurysm

The Journal of the American Medical Association (JAMA) reported in 2015 a two-fold increase in risk of dissection and aneurysm within 60 days of using the fluoroquinolones.

The British Medical Journal (BMJ) also published a comprehensive study of 1.7 million patients in 2015 that chillingly found a three-fold increase in aortic aneurysms:

Lawsuit Against Former FDA Commissioner   

Former FDA Commissioner, Margaret Hamburg

Former FDA Commissioner Margaret Hamburg

FederalCharges.com has reported that former FDA Commissioner Margaret Hamburg has been named in a federal lawsuit that alleges she conspired to:

…get a dangerous drug approved (Levaquin) even though it had serious and sometimes deadly side effects. She did this, the lawsuit alleges, to financially benefit the hedge fund her husband ran, which had large stakes in Johnson & Johnson, which makes the drug.

The complaint also alleges that Levaquin is responsible for over 5,000 deaths.

Hamburg’s attorneys called the lawsuit “patently false,” “defective,” and lacking in factual evidence. “We are confident the court will dismiss his claims in their entirety.”

Whatever the merits of the lawsuit against Hamburg, it highlights the seriousness of the drug’s harmful effects on thousands of people and possible FDA complicity in approving a dangerous and deadly drug.

What Is Being Done?

Levaquin is a powerful drug that has helped countless individuals. But the dark side of Levaquin has been underplayed by the FDA and too nonchalantly used by physicians for ailments that could be improved or cured by less potent drugs. This inappropriate usage has led to serious and life threatening complications for many.

The FDA has known of the problems with Levaquin for some time. In 2006, the Public Citizen Research Group  petitioned the FDA to add a black box warning to the label. In 2008, the FDA agreed to add the black box warning for the high risk of tendinitis and tendon rupture. However, no FDA communication to this effect was sent to physicians. Levaquin went on to be the best selling antibiotic in the US by 2010.

Also in 2010, Johnson and Johnson, makers of Levaquin, settled over 800 lawsuits out of 3,400 suits filed charging that patients were not made aware of the dangers involving the drug and paid out $1.8 million to one plaintiff who suffered tendon rupture.

DrugWatch.com reported in 2013 that:

…the FDA released a Safety Communication warning about over-prescribing and said current warnings were not clear enough. Specifically, the agency said “the potential rapid onset and risk of permanence were not adequately described,” and the “permanent damage among patients exposed to these medications cannot be calculated.

In 2015Dr. Charles Bennett, who runs one of the largest pharmaceutical watchdog groups in the country, the Southern Network on Adverse Reactions (SONAR), filed a citizen petition with the FDA regarding fluoroquinolones asking that mitochondrial toxicity and serious psychiatric events be added to the FDA’s black box warning.

Bennett has collected “testimony from thousands of patients all across the country, patients who experienced muscle weakness, chronic fatigue, cardiomyopathy, hearing loss, developmental disorders, severe depression or nerve damage after taking Levaquin and related drugs.”

Where Do Things Stand Now?

In May of 2016, the FDA finally upgraded its warnings about the use of fluoroquinolones and Levaquin.

Paul Auwaerter, with Medscape Infectious Diseases and the Johns Hopkins University School of Medicine, states that the FDA has recognized the increased risk of fluoroquinolones for Clostridium difficile infection (compared with many other antibiotics), tendinopathy, arthropathy, QT prolongation, retinal issues, and central and peripheral nervous system toxicities.

Auwaerter adds that the FDA now feels that owing to potential irreversible or permanent side effects, these drugs should not be used for first-line treatment for common upper respiratory tract infections such as bronchitis or sinusitis, or for urinary tract infections.

He concludes definitively that “it does not make sense to prescribe these drugs . . . to treat conditions that could be treated with a narrower-spectrum and more targeted drug.”

What Should You Do?

Drugs like Levaquin are overprescribed and used inappropriately by many physicians who don’t realize their potential hazard. Unfortunately, the onus is on you to protect yourself. Here is what you should consider:

  • Ask your doctor which antibiotic they are prescribing.
  • Fluoroquinolones should be reserved for severe, life-threatening infections.
  • Discuss alternative drugs or treatments with your physician.
  • If you must take the drug for a serious condition, tell your doctor immediately of any symptoms you experience.
  • Read all black box warnings and lists of side effects.
  • Sign up for FDA consumer drug updates.

You must protect yourself and your family against the misuse of these powerful drugs. Don’t be a victim.

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

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Awareness

Boy or Girl – Baby Gender Selection Issues

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Some parents have the possibility to opt for gender selection; however, being able to decide whether to have a baby boy or girl is a controversial issue.

Many couples expecting a baby do not think it’s a big issue whether they have a boy or a girl; however there are several medical, social, and personal reasons that could influence parents to recur to some form of gender selection.

Like many other controversial practices, the legality of gender selection, also known as sex selection, varies from country to country.

The Legality of Baby Gender Selection

The United States has perhaps some of the most relaxed laws regarding baby gender selection in the world. Most European countries and Australia, on the other hand, have bans on sex selection and only allow it for medical reasons. For example, if a parent is a carrier of a mutation or gene with more chances of manifesting itself in a certain gender, baby gender selection is valid. However, if parents simply wish to balance the ratio of boys and girls in their family, they are not allowed to recur to sex selection.

This has generated a form of medical tourism in which couples from countries where gender selection is illegal, like the UK, travel to the US in order to be able to choose whether to have a baby boy or girl.

On the other hand, sex selection is illegal in the two most populated countries on Earth, China and India. In these countries, baby gender selection has been performed clandestinely for many years and for reasons other than family balancing or avoiding genetic diseases. In these societies, having a baby boy is preferred mainly for cultural and economic reasons. Parents believe that boys have better chances of earning income and eventually support them when they reach an old age.

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Methods of Baby Gender Selection

There are two major types of gender selection methods: the first one is called sperm sorting, and involves separating X-chromosome sperm from Y-chromosome sperm by flow cytometry, a purification technique in which chromosomes are suspended in a stream of sperm and identified by an electronic detector before being separated. Intra-uterine insemination or in-vitro fertilization can then be performed with the enriched sperm. The success rates for this method vary from 80% to 93%.

The other method, called pre-implantation genetic diagnosis, consists in generating several embryos through in-vitro fertilization, which are then genetically tested to determine a baby’s gender. The chosen embryos can then be implanted. This method has a success rate of almost 100%; however, it can be quite expensive, costing up to $15,000.

Issues Regarding Baby Gender Selection

While there are few objections against baby gender selection when it is performed for medical reasons, it has become a highly controversial issue when it is used for balancing the number of boys or girls in families. Some people raise the obvious ethical question of whether people who opt for gender selection are “playing God” by manipulating whether to have a baby boy or girl. Others believe that new parents will raise a baby more appropriately if he or she belongs to their preferred gender.

Gender Imbalance Caused by Baby Gender Selection

Gender selection has caused demographic concern in China and India since it has contributed to generate a gender imbalance in the populations of those countries. In some regions of China, for example, the sex ratio for newborns is 118:100, boys to girls. This phenomenon has in turn been associated with social problems such as an increase in violence and prostitution.

It seems like a logical solution for governments around the globe to legalize baby gender selection but to analyze the personal reasons why each couple intends to select a baby boy or girl. Gender selection for medical reasons should even be encouraged, since it could prevent serious genetic diseases such as cystic fibrosis, Huntington’s disease, and Haemophilia A. Balancing the gender ratio of a family should be accepted if by doing this, a healthy family environment is created. On the other hand, China and India have shown that baby gender selection as a result of a bias towards a particular gender can not only create a gender imbalance in the population, but contribute to social problems as well.

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

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Organic Certification: What the USDA Organic Label Means

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In Brief

  • The Facts:

    Organic and natural labels mean different things, and various types of labels tells you what percentage of ingredients are actually organic. We'll explore what to look for.

  • Reflect On:

    Do you sometimes buy products thinking they are organic or fully natural based on their wording? Have you later found out that those products aren't natural or organic at all? Read labels more closely at grocery stores to be aware.

Don’t get conned by fraudulent claims of “natural” or “organic.” Learn what to look for, and why it’s important, to ensure you’re getting the quality you are paying for.

The industrial age of the 20th century brought about changing agricultural practices that have generated increasing alarm about the effects of these practices on the environment and health. The use of chemical fertilizers and pesticides, antibiotics, hormones, irradiated and genetically altered food and fiber products has created a groundswell of rightful concern. It has led to the growing demand for non-toxic, organic products that many are willing to pay a higher price for to ensure the healthful purity of food and clothing provided for their families.

With such profit opportunities, it’s little wonder that the lucrative organic product market has suffered abuse with so-called “organic” labels being fraudulently placed on products that have not earned the right. As a result of pressure from farming and consumer groups, legislation for the standardization of organic certification was introduced in the 1980s. It has been updated to include more vigorous enforcement and control methods since, with the current standards established in 2002 by the USDA.

The Standards of USDA Organic Certification

Specific standards must be met in order to legally claim a product as USDA certified organic. Organic producers must utilize methods that conserve water, maximize soil health, and reduce air pollution. The specific standards to earn USDA organic certification include:

Free of synthetic chemicals such as insecticides, herbicides, fertilizers, hormones, antibiotics, and additives

Free from irradiation and genetically modified organisms

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Agricultural products grown on land that has been free of prohibited substances for a period of three years

Animals used for meat, eggs, milk or other animal products must be exclusively fed foods that are organically grown, may not be given antibiotics or hormones, and must have access to outdoors.

Clean and sanitized harvesting and processing equipment throughout the process from harvest to finished, packaged product

Detailed chain-of-handling records from the field through final sales

Physical separation of certified organic products from non-organic products throughout the process of production

Regular on-site inspections from USDA-approved inspectors to ensure compliance

Understanding the Certified Organic Label

Once the rigorous process of certification has been completed, organic producers may place the USDA certified organic seal on their products. Currently, there are four levels of certified organic products, with a specific definition of the percentage of organic ingredients the final products contains. They are as follows:

• 100% organic: all production methods and ingredients are USDA certified organic.

• Organic: at least 95% of the production methods and ingredients are USDA certified organic with remaining ingredients included on the National List of allowed ingredients.

• Made With Organic Ingredients: at least 70% of the ingredients are USDA certified organic with remaining ingredients included on the National List of allowed ingredients.

• No organic wording or seal: less than 70% of the ingredients are USDA certified organic and no claims may be made on the front or back of the product.

Manufacturers or producers who knowingly label a product “organic” when it does not meet the USDA standards are subject to fines up to $11,000 per violation.

Why Organic Certification is Important

When you see the official USDA organic certification seal on food, clothing, and bedding products, you can be assured that these products have met the meticulous standards required and are free of chemicals, toxins, antibiotics, and hormones. When you see the USDA certified organic label, you will understand the value of the higher priced organic products as compared to non-organically produced products.

With the current stringent organic certification requirements enforced by regular inspections from USDA accredited agents, the USDA certified organic label has great meaning and importance to the consumer. Look for the label to know that you are getting the quality you are paying for.

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

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Awareness

WHO Finds Global Lack Of Inactivity Rising Especially In Wealthier Countries — What You Can Do

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In Brief

  • The Facts:

    Inactivity is on the rise and it's the cause of a wide range of health concerns. Our population is only becoming more inactive, not less, and it's time to change that.

  • Reflect On:

    There are many factors of our modern world that make us less active. Our jobs, driving rather than walking/biking, too much screen time. What can you do differently to bring more activity into your life? What story stops you from starting?

The World Health Organization (WHO) estimates that more than a quarter of the entire population on this planet are not getting enough physical exercise, this number has barely improved since 2001. There are many factors that contribute to this, but just how much damage are we doing by failing to be active?

The lack of physical exercise raises the risk of many health problems, such as heart disease, type-2 diabetes and various types of cancers.

Interestingly, according to their study published in The Lancet Global Health, higher income countries, such as the UK, were among the least active population. Women were also found to be more sedentary throughout the world, excluding two regions in Asia.

The study looked at self-reported data on activity levels from 358 population based surveys covering 168 countries and included 1.9 million people.

The populations of higher income countries, which include the UK and USA showed an increase in the proportion of inactive people and had actually risen from 32% in 2001 to 37% in 2016, in the lower income countries it remained at 16%.

Those who were classified as inactive did less than 150 minutes of moderate exercise and around 75 minutes of intense activity per week.

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It was found that women were less active than men overall, except for in South and Central Asia, the Middle East, North Africa and higher-income Western countries. The authors believe that this was caused by a few different factors including extra childcare duties and cultural perspectives that may have made it more difficult for them to exercise.

Why More Inactivity In Wealthier Countries?

According to the researchers, in the wealthier countries, many of the jobs have transitioned to more office or desk jobs, meaning a more sedentary type of lifestyle. On top of that much of the population of these countries drive automobiles or take public transit to and from work which in many cases accounts for a lot of their time.

In the lower income countries, many of the jobs require the people to be more active, are physically demanding and people often have to walk to and from their jobs.

The WHO has had a goal to reduce the global levels of inactivity by 10% by 2025, the authors of the study feel that at the rate we are currently going, this target will be missed.

Lead author of the study, Dr. Regina Guthold said, “Unlike other major global health risks, levels of insufficient physical activity are not falling worldwide, on average, and over a quarter of all adults are not reaching the recommended levels of physical activity for good health.”

Regions with increasing levels of insufficient physical activity are a major concern for public health and the prevention and control of non-communicable diseases.”

Co-author, Dr. Fiona Bull added, “Addressing these inequalities in physical activity levels between men and women will be critical to achieving global activity targets and will require interventions to promote and improve women’s access to opportunities that are safe, affordable and culturally acceptable.”

According to the WHO,

Exercise guidelines for 19- to 64-year-olds

How much?

  • at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity every week
  • strength exercises on two or more days a week that work all the major muscles
  • break up long periods of sitting with light activity

What is moderate aerobic activity?

  • Walking fast, water aerobics, riding a bike on level ground or with a few hills, doubles tennis, pushing a lawn mower, hiking, skateboarding, rollerblading, volleyball, basketball

What counts as vigorous activity?

  • Jogging or running, swimming fast, riding a bike fast or on hills, singles tennis, football, rugby, skipping rope, hockey, aerobics, gymnastics, martial arts

What activities strengthen muscles?

  • lifting weights, working with resistance bands, doing exercises that use your own body weight, such as push-ups and sit-ups, heavy gardening, such as digging and shovelling, yoga

What activities are both aerobic and muscle-strengthening?

  • circuit training, aerobics, running, football, rugby, netball, hockey

Final Thoughts

I was surprised to see that the WHO didn’t touch on inactivity due to too much screen time — watching television, Netflix, Facebook scrolling, messaging, texting, browsing etc. Certainly, the increase in screen time plays a roll with the amount of inactivity, especially in the higher income countries. If you are someone who spends too much time staring at a screen, then it is important to consider the above information. Can you limit your screen time and replace it with something active? Or would you consider jumping rope, or rebounding while watching the television? Our health is our greatest wealth and having awareness about an issue is the first way to create change and take responsibility for our lives.

Could you walk or bike to work instead of drive? What about trying a new sport? Could you commit to adding a few hours each week of physical activity? These small decisions could have a profound impact on your health, longevity and overall well-being.

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Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

Watch the interview here.
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