FDA Warnings Against Ciprofloxacin or Cipro – Failure To Warn Can Lead to Lawsuits

Ciprofloxacin is an antibiotic used to treat common types of bacterial infections, including urinary tract and ear infections. Approved by the U.S. Food and Drug Administration (FDA) in 1987, Ciprofloxacin (Cipro) is in a class of synthetic antibacterial drugs called fluoroquinolones, and has become one of the most commonly prescribed antibiotic treatments. However, in 2008 the FDA required Cipro’s warning labels to alert patients of potential side effects, including tendon ruptures. Five years later, in 2013, the FDA required the use of labels warning patients about a central nervous system condition called peripheral neuropathy. Subsequent pharmaceutical liability lawsuits have claimed the manufacturers of Cipro and other fluoroquinolones had previously known about the associated health risks, yet failed to warn both patients and healthcare professionals.

What is Peripheral Neuropathy?

Peripheral neuropathy is a general term for numerous kinds of nerve damage occurring between the brain, spinal cord, and body’s tissues (muscles, tendons, ligaments, ligaments and connective tissue). The two categories of peripheral neuropathy are motor nerve damage and sensory nerve damage:

  • Motor nerve damage affects coordination and use of the hands and arms, resulting in muscle spasms, difficulty walking, significantly decreased strength, and muscle cramping.
  • Sensory nerve damage affects the sense preceptors of the nerves serving the skin, causing numbness, paresthesia (tingling sensations), sharp pain, and extreme sensitivity to touch.

Cipro’s Effects on Collagen

Collagen is a protein found in connective tissues, vital for providing strength and structure to the human body. Collagen is necessary for healthy relationships between bones, cartilage, tendons, muscles, and skin. Studies have shown that Cipro and other fluoroquinolones erode existing collagen and prevent collagen synthesis. The tendon ruptures cited in the FDA’s 2008 mandatory warnings are thought to be caused by this collagen breakdown. Paired with the potential for peripheral neuropathy, collagen degeneration provides excessive risks to patients prescribed Cipro.

Documented Reactions to Patients Taking Fluoroquinolones

In 2001, twelve years prior to the FDA’s warning requirements, Dr. Jay Cohen published an article based on documented patient reactions to fluoroquinolones. These included the following:

  • 91% of patients experienced nervous system symptoms: pain, weakness, headaches, numbness, paresthesia, memory loss, anxiety
  • 73% of patients experienced musculoskeletal symptoms: tendon ruptures, tendinitis, muscle weakness, joint pain and swelling
  • 42% of patients experienced sensory symptoms: tinnitus (ringing in the ears), visual impairments, loss of ability to smell
  • 36% of patients experienced cardiovascular symptoms: chest pain, difficulty breathing, tachycardia
  • 29% of patients experienced skin conditions: rashes, hair loss
  • 18% of patients experienced gastrointestinal symptoms: abdominal discomfort, nausea, vomiting, diarrhea

Statistics and Facts About Fluoroquinolone Use

  • Since 2013, several fluoroquinolones have been recalled by their manufacturers, leaving Cipro as the most prescribed.
  • In 1991’s Persian Gulf War, US troops were prescribed Cipro as protection against potential chemical warfare.
  • In 2001, Cipro was prescribed to thousands in Washington D.C. and in the postal service to protect against potential anthrax exposure.
  • Since 2005, 79,000 reports of harmful reactions to Cipro have been reported.
  • Since 2005, 1,700 fatalities have been linked to Cipro.

Altman & Altman, LLP – Boston’s Drug Liability Lawyers

If you have suffered a medical condition as a result of the misrepresentation of Cipro or another type of fluoroquinolone drug, you may be entitled to compensation for your medical expenses, lost wages, and pain and suffering. At Altman & Altman, LLP, our dedicated legal team believes pharmaceutical companies must be held responsible for negligent actions, especially those that  prioritize profit over public health. Our Boston Cipro lawsuit attorneys will examine every detail of your case, utilizing our long-term relationships with experts in both the medical and pharmaceutical fields. With offices in Boston, Cambridge, and Salem, our firm has proudly served all of Massachusetts for over 40 years. Contact us today for a free consultation about your case.


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