FDA Advisory Committee Recommends Label Change for Fluoroquinolone Antibiotics
The U.S. Food and Drug Administration met November 5, 2015, to discuss the risks and benefits of using fluoroquinolones on patients with bronchitis, sinusitis, and urinary tract infections. Fluoroquinolone drugs are a powerful class of antibiotic drugs and include brand names Cipro, Levaquin, and Avelox.
Fluoroquinolone antibiotics have been linked to a list of serious side effects. The FDA cited adverse event reporting from patients highlighting a “constellation of symptoms” that is referred to as Fluoroquinolone-Associated Disability, or FQAD. People may have FQAD are described as:
- Patients who experience two or more adverse events in two or more body systems including peripheral neuropathy, neuropsychiatric, musculoskeletal, senses, cardiovascular, and skin.
- Patients who were previously healthy.
- Patients who took fluoroquinolone to treat urinary tract infections, bronchitis, or sinusitis.
- Patients who had a substantial disruption of their normal life functions.
Peripheral neuropathy is a type of damage to the central nervous system and can make a patient experience severe pain, difficulty moving, and problems with involuntary functions like breathing, digestion, and circulation. Peripheral neuropathy causes weakness, numbness, tingling, burning, and other sensations of pain often in the hands, arms, legs, and feet.
Media reports have highlighted stories of formerly healthy patients who took fluoroquinolone drugs like Cipro and Levaquin and developed severe nerve damage causing life-changing injuries. FDA concerns about the safety of fluoroquinolone drugs increased after a review of a large number of adverse event reports.
FDA Says Label Change Needed
FDA review panel members from the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted overwhelmingly that the benefits and risks for fluoroquinolone antibacterial drugs support a need for a label change. The FDA will review the findings of this panel and decide whether or not a black box or other safety communication should be added to the labels of fluoroquinolone drugs like Levaquin and Cipro.
Thousands of lawsuits have been filed in state and federal courts across the United Stated by patients who experienced severe nerve damage and other serious injuries after taking quinolone-containing antibiotics Levaquin, Cipro, and Avelox. If you or someone you know has taken these drugs and experienced severe nerve damage, our product liability attorneys can help. Cohen & Malad, LLP has been litigating serious personal injury claims against large drug manufacturers for many years and can help you get the compensation you deserve.