Product News and Recalls

FDA: Fluoroquinolones Need Stronger Warning Labels

fda wants stronger warnings on fluoroquinolonesFollowing a November 5 hearing, a U.S. Food and Drug Administration (FDA) advisory panel has recommended that fluoroquinolone manufacturers include stronger warning labels on their drugs.

Fluoroquinolone’s, or FQLs for short, are a family of broad-spectrum antibiotics used to treat hospital-acquired respiratory and urinary infections. Despite their widespread use, drugs like Levaquin, Avelox, and Cipro have been linked to multiple severe side effects. In 2008, the FDA requested that manufacturers include a boxed safety warning that fluoroquinolones have been linked to tendon damage and rupture; and in 2013, the agency strengthened warnings that fluoroquinolones can cause severe and possibly permanent nerve damage, resulting in a condition known as peripheral neuropathy.

It is estimated that almost everyone in the United States will be treated with fluoroquinolone antibiotics at some point in their life. A patient being treated with fluoroquinolones for a mild urinary infection will be at the same risk of Fluoroquinolone-Associated Disability (FQAD) as someone receiving treatment for anthrax. In light of this risk–reward imbalance, and following testimony from patients who say they suffered FQAD after taking fluoroquinolone antibiotics, the FDA panel voted to strengthen warning labels for treatment of sinus infections (21–0), urinary tract infections (20–1), and bronchitis linked to chronic obstructive pulmonary disease (18–2, with one abstention).

Numerous other patients in addition to those who gave testimony claim that fluoroquinolone drugs like Levaqin, Avelox, and Cipro are responsible for their nerve damage and tendon ruptures. You should speak to your doctor if you have any concerns about the medications you are taking. Did you suffer from Fluoroquinalone-Associated Disability after using one of these antibiotics? If so, contact Lopez McHugh today to discuss your case free of charge with a qualified pharmaceutical attorney.