What is the Problem with Fluoroquinolone Antibiotics and Levaquin Initial Attempt to Add Warning: In August 2006, Public Citizen & the Illinois Attorney General petitioned the U.S. Food and Drug Administration to add a “Black Box Warning” to Levaquin’s packaging and require pharmacists to give patients FDA-approved medication guides that also carry the warning of tendon rupture associated with the drug. In addition, a nonprofit group petitioned for the same warnings as far back as 1996, however as the FDA granted the petition, it ended up being buried in the list of possible adverse reactions and so thus far been inadequate. FDA Adds Black Box Warning to Levaquin: The Food and Drug Administration ordered makers of fluoroquinolone drugs — a potent class of antibacterials — to add a prominent “black box” warning to their products and develop literature for patients emphasizing the risks. The FDA has stated in part that, “the benefits of the drug outweigh the risks.” The Number of Levaquin Induced Tendon Ruptures are Startling Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of the early warning signals, such as the onset of tendon pain, and switched to other antibiotics. The FDA must act and require black box warnings and patient information guides - (Source: Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group) Some researchers speculate that fluoroquinolones are toxic to tendon fibers and may decrease blood supply in tendons that already have a limited amount of blood supply. Levaquin Tendon Rupture Statistics The FDA’s database shows 100s of ceases cases of tendon ruptures, tendonitis, and other tendon disorders. These numbers may be higher since the recent FDA announcement. • 61% of the tendon ruptures reported to the FDA was caused by Levaquin. • 23% of the tendon ruptures reported the FDA was caused by Cipro. Signs & Symptoms of Tendon Rupture The tendon most frequently associated to the Levaquin induced ruptures is the Achilles tendon, however Levaquin has also been linked to tendon ruptures in the rotator cuff (shoulder), the biceps, the hand, and the thumb. Below is a brief list of symptoms often associated with an Achilles tendon rupture: • sudden and severe pain • swelling and bruising • difficulty walking Signs & Symptoms of Tendonitis Symptoms of tendonitis that are produced near a joint aggravated by movement include the following: • Pain • Tenderness • Mild swelling, in some cases Tendonitis in various locations in your body produces these specific types of pain: Tennis elbow. This type causes pain on the outer side of your forearm near your elbow when you rotate your forearm or grip an object. Golfer’s elbow causes pain on the inner part of your elbow. Achilles tendonitis. This form causes pain just above your heel. Adductor tendonitis. This type leads to pain in your groin. Patellar tendonitis. In this type, you experience pain just below your kneecap. Rotator cuff tendonitis. This tendinitis leads to shoulder pain. If you or a loved one is suffering from an injury caused by Levaquin, please call the Garrett Law Office – 1-888-427-7388 FDA warning from Cipro and other fluoroquinolones http://www.youtube.com/watch?v=GBkIgki9tCE&feature=player_embedded FDA warning