The U.S. Food and Drug Administration (FDA) has issued a drug safety communication in which they advise restricting fluoroquinolone antibiotic use for uncomplicated infections who have other treatment options. An FDA safety review showed that fluoroquinolones are associated with adverse side effects that can be disabling and potentially permanent. These adverse effects involve the tendons, muscles, joints, nerves and the central nervous system.
With this drug safety communication, the FDA is directing the manufacturers of these drugs to modify the product label and medication guides to reflect this new information. The safety communication further advised those who are currently taking fluoroquinolones and experiencing side effects such as the feeling of "pin and needles," a tingling or pricking sensation, confusion or hallucinations to contact their doctor immediately. Health care professionals are advised to stop treating with fluoroquinolones immediately if a patient reports these or other adverse side effects, and switch to another antibacterial drug to complete the patient's treatment course.
What are fluoroquinolones?
The U.S. National Institutes of Health (NIH) describe fluoroquinolones as “a family of broad spectrum, systemic antibacterial agents that have been used widely as therapy of respiratory and urinary tract infections…. The fluoroquinolones are indicated for treatment of several bacterial infections, including bacterial bronchitis, pneumonia, sinusitis, urinary tract infections, septicemia and intraabdominal infections, joint and bone infections, soft tissue and skin infections, typhoid fever, bacterial gastroenteritis, urethral and gynecological infections, and pelvic inflammatory disease and several other infectious conditions.” The NIH lists the following as common side effects of fluoroquinolones:
- Gastrointestinal disturbances
- Skin rash and allergic reactions
The less common, but more severe side effects include:
- QT prolongation (a risk factor for sudden death)
- Tendon rupture
Which drugs may be dangerous?
The following is a list of the FDA-approved fluoroquinolone antibacterial drugs and their active ingredient:
- Avelox (Moxifloxacin)
- Cipro (Ciprofloxacin)
- Cipro extended-release (Ciprofloxacin extended-release)
- Factive (Gemifloxacin)
- Levaquin (Levofloxacin)
- Moxifloxacin Injection (Moxifloxacin)
- Ofloxacin (Ofloxacin)
Doctors have prescribed fluoroquinolone antibiotics to millions of patients, but these drugs have proven to be linked to dangerous side effects which can cause permanent injury or death. In January of 2016, five former Levaquin users filed a negligence lawsuit against Johnson & Johnson, the drug's manufacturer, claiming that the pharmaceutical giant mislabeled the drug and failed to warn consumers about the potentially harmful and deadly side effects from taking the drug.
Those who have taken fluoroquinolone antibiotics and experienced adverse side effects may want to speak with an experienced, Maryland defective drug lawyer from Plaxen Adler Muncy, P.A. We are here to listen to your story and offer sound, legal guidance on the options available to you.
Plaxen Adler Muncy, P.A. is a premier personal injury law firm serving clients injured by defective drugs or medical devices throughout Maryland. To speak with a Maryland defective products attorney, or to reserve an appointment at our office, please call us at 410-730-7737 or fill out our contact form to schedule a free consultation to discuss your case today.