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“Black Box” Warning Issued for Levaquin and Cipro

-InjuryBoard.com

07/22/2008- Last week the FDA announced that fluoroquinolone antimicrobial drugs, like Levaquin and Cipro, would now carry the agency’s strictest warning. Antimicrobial drugs are used to treat or prevent certain types of serious bacterial infections, including pneumonia. These drugs have been linked to an increased risk of tendonitis and tendon rupture. The FDA notified manufacturers that the Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits outweigh the risks associated with the medications.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

The FDA also notified drug manufacturers that a Medication Guide should now be provided with this class of medication to ensure that patients understand the risks that they may be exposed to. The agency advised physicians that caution should be exercised when prescribing fluoroquinolones and said that each patient’s risk should be evaluated on a case-by-case basis.

If you or a loved one have experienced serious side effects or injury as a result of Fluoroquinolone antibiotics such as tendonitis, torn ligament, or ruptured tendons, you may be entitled to compensation. Contact one of our Fluoroquinolone lawyers today for more information regarding your legal rights. For more information about a potential Fluoroquinolone lawsuit, or Fluoroquinolone side effects, fill out our free case evaluation form or call the toll-free number listed below.

 
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