Black Box Warning

Black Box Warnings Information, Resources and Attorney Referrals

Black Box Warning

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**** We are not doctors or attorneys and do not provide medical or legal advice ****

Black Box Warning

What is a Black Box Warning?

A "Black Box Warning" is the strongest warning that the FDA requires a pharmaceutical company to place on the box or the literature of its product, warning users of significant risk of serious or even life-threatening adverse effects.  

A Black Box Warning is sometimes referred to as black label warnings.


Black Box Warning

Essential Trace Minerals   *  Genetically Modified Organism  *  Organic For Life  Vitamin and Mineral Deficiency

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October 2008 - Washington, D.C.

The U.S. Food and Drug Administration Issues a Black Box Warning on the Use of Vaginal Mesh and Synthetic Mesh Used in Pelvic Organ Prolapse Surgeries

The U.S. Food and Drug Administration has issued a black box warning on the use of vaginal mesh used in pelvic organ prolapse and stress urinary incontinence surgeries.

The FDA stated in the Black Box Warning; “Most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of pelvic organ prolapse and/or stress urinary incontinence.” 

Levaquin Placed on the Black Box Warning

Levaquin (levofloxacin) is a Fluoroquinolone Antimicrobial Drug that is prescribed by doctors for their patients that have an infection in their;  lung, sinus, skin and urinary tract infection treatment. 

Levaquin is manufactured by Ortho-McNeil-Janssen Pharmaceuticals.

On July 8, 2008, the FDA issued a Black Box Warning informing and warning patients about the increased risk of developing tendonitis and tendon rupture. The FDA stated that tendon rupture can occur during or after completing the use of Levaquin.  There have been patients that developed cases of tendonitis or tendon rupture several months after completion of Lavaquin.

The risk of tendonitis or tendon rupture is increased in patients taking Levaquin who are over the age of 60 as well as patients who have heart, kidney or lung transplant recipients and patients who are using concomitant steroid therapy. 

Pain, inflammation, swelling and tears of tendons including the Achilles, shoulder, hand, or other tendons can happen in patients taking Levaquin. 

Symptoms and signs that you have experiences a tendon rupture can include a snap or pop in the tendon area, bruising right after and injury to the tendon area or inability to move the affected area or bear weight. 

The Black Box Warning for patients using Levaquin applies to any usage of the drug in tablet, capsule or injectable formulations. 

If you or someone you love has any of these signs or symptoms after taking Levaquin, you will need to see your physician as soon as possible.


What are essential trace elements?

Essential trace elements are not only required but "vital" by men and women, boys and girls, for optimum health.  

The "essential trace elements" daily requirements range from 50 micrograms to 18 milligrams per day, depending on the element.

Essential trace elements act as catalytic or structural components of larger molecules in the body and have specific functions making them indispensable for life and optimum health. 

Medical research over the past 25 - 30 years has identified six essential trace elements whose functions were previously unknown. These six include;


In addition to the long-known deficiencies of iron and iodine, signs of deficiency for chromium, copper, zinc, and selenium have been identified in free-living populations. Four trace elements were proved to be essential for two or more animal species during the past decade alone. Marginal or severe trace element imbalances can be considered risk factors for several diseases of public health importance, but proof of cause and effect relationships will depend on a more complete understanding of basic mechanisms of action and on better analytical procedures and functional tests to determine marginal trace element status in man.

More about Essential Trace Elements

Essential trace elements and minerals including; calcium, chromium, copper, fluoride, fulvic acid, iron, iodine, magnesium, manganese, molybdenum, phosphorus selenium and zinc have been proven to prevent and reverse a wide number of variety of diseases and medical conditions. 

Among the diseases and medical conditions that essential trace elements have been treated include; cardiovascular,  endocrine, gastrointestinal, genetic, infectious, kidney, ophthalmologic, skeletal and post-surgical trauma/healing and recovery.

Essential trace elements and minerals supplementation have shown effective in people of all ages including healthy people as well as women who may be pregnant or breast-feeding as well as adolescents and people over 65. 


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