Legal News You Can Use

Now, because of mounting evidence that the drug levequin alsong with cirpro and others in it is class of flouroquinolone drugs, can cause injury to tendons and tendon ruptures, the FDA has issued its most urgent safety warning- THE BLACK BOX. 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.
In 2005 various groups including the consumer group Public Citizen began petitioning the FDA to put the black box warning on these drugs. They eventually sued the FDA prior to the FDA’s decision to take this action.

It is not really understood how these drugs cause the tendon ruptures but studies show that the drugs have a toxic effect on cellular components of connective tissue. The most commonly effected tendons are the Achilles tendon in the heel and the tendons connecting muscles to bones in the hand, shoulder and arm.

The FDA alert indicates that this risk is increased in patients over age 60 and in patients taking steroids. Physicians are advised to take patients off fluoroquinolone medications at the first sign of tendon pain or swelling.

The had filed a petition asking for these warnings two years ago and eventually sued the FDA prior to the FDA’s  The FDA would not cite a specific number, but admit they have received several hundred complaints

The warning now reads”Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin, during and after therapy. This risk is increased in patients over 65 years old, and is further increased with concomitant corticosteroid therapy. Discontinue in patients experiencing pain, inflammation, or tendon rupture.”

Unfortunately for some, the warning again comes too late.