FDA issues new warnings for Fluoroquinolone Antibacterial Drugs. (Cipro & Levaquin)
July 26, 2016 – San Diego, CA. The FDA has just released a new warning from the MedWatch System, (The FDA safety Information and Adverse Event Reporting Program).
A Black Box warning on Cipro and Levaquin is the strongest consumer warning from the FDA.
Direct from the source:
ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.
FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.
FDA is continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed. See the FDA Drug Safety Communication for additional information, including a Data Summary and Additional Information for Health Care Professionals and Patients.
BACKGROUND: The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone
RECOMMENDATION: Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication).
Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.
Information on Cipro Lawsuits here.
Information on Levaquin Lawsuits here.
Note: The information provided in this article is based on reports from publicly available sources, including news outlets, police reports, and eyewitness accounts. National Injury Help has not independently verified all details of the reported incident. If you find any inaccurate or outdated information, please contact us, and we will review and update the content as appropriate. The photo used in this post is for illustrative purposes only and does not depict the actual scene of the incident.
Disclaimer: The content of this article is intended for informational purposes only and does not constitute legal advice or establish an attorney-client relationship with National Injury Help. For legal assistance specific to your case, we encourage you to contact a qualified attorney.
Free Case Evaluation
Contact Us today for a FREE, Immediate Case Evaluation
Contact Us today for a FREE, Immediate Case Evaluation
Categories
Recent post
- Phoenix, AZ – Roberto Olivas Killed in High-Speed Crash on Van Buren St
- Phoenix, AZ – Man Dies After Pedestrian Crash Near Camelback Rd
- Phoenix, AZ – Brittany Geib and Her Dog Killed in Hit-and-Run on 51st Ave
- Phoenix, AZ – Una persona herida tras choque entre dos autos en 27th Ave y Yorkshire Dr
- Phoenix, AZ – Three Hurt After Multi-Vehicle Crash on Camelback Rd and 35th Ave