“Black Box” Warning Issued for Levaquin and Cipro

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 tendinitis 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.