FDA Strengthens Warning Labels on Class of Antibacterial Drugs
The Food and Drug Administration (FDA) announced on Tuesday, 7/26 that they are revising their boxed warning labels on packages of a class of antibacterial drugs known as fluoroquinolones. The FDA’s boxed warning labels, commonly referred to as “black box” warnings, alert doctors and patients that certain types of drugs or medical devices may pose life-threatening risks.
The FDA announced that fluoroquinolones are linked to dangerous side effects that have the potential to leave patients permanently disabled.
Fluoroquinolone drugs are antibacterial medications used to treat serious infections such as bronchitis, sinusitis, urinary tract infections (UTIs), and others. Fluoroquinolone medications currently on the market include:
Tuesday’s FDA Drug Safety Communication about fluoroquinolones stated that patients taking these types of drugs, either orally or through an injection, may experience devastating and potentially irreversible side effects including:
- Tendon rupture
- Peripheral neuropathy – nerve damage in the hands and feet that can result in permanent weakness, numbness, and pain
- Myasthenia gravis – Weakness and rapid muscle fatigue
- Other central nervous system effects
The FDA determined that fluoroquinolones should only be prescribed to patients who have no other treatment options to combat serious infections. According to Tuesday’s Drug Safety Communication: “the risk of these serious side effects generally outweighs the benefits [of fluoroquinolones].”
The FDA is advising patients that are taking any type of fluoroquinolone drug to contact their healthcare professional immediately if they experience any of the following symptoms:
- Pain in joints or tendons
- Muscle weakness
- Numbness in the arms or legs
- Tingling, prickling or “pins and needles” sensations