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Black Box Warning
www.BlackBoxWarning.com

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.  Black Box Warnings are  also sometimes referred to as black label warnings.

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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 and Stress Urinary Incontinence 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.