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Cipro is a powerful antibiotic used to treat a variety of bacterial infections. However, the medication is also associated with a number of potentially serious complications, including peripheral neuropathy and tendon injuries.

What is Cipro?

Cipro (ciprofloxacin) is a fluoroquinolone antibiotic marketed by Bayer AG that has been on the market since 1987. It is currently approved to treat:

• Urinary tract infections
• Acute uncomplicated cystitis
• Chronic bacterial prostatitis
• Lower respiratory tract infections
• Acute sinusitis
• Skin and skin structure infections
• Bone and joint infections
• Complicated intra-abdominal infections
• Infectious diarrhea
• Typhoid fever
• Uncomplicated cervical and urethral gonorrhea
• Complicated urinary tract Infections and pyelonephritis
• Inhalation anthrax (post-exposure)
• Plague

In 2011, over 23 million Americans received a prescription for an oral antibiotic, and 70% were prescribed Cipro. Other drugs in the fluoroquinolone class include Avelox and Levaquin.

FDA Says Cipro Risks Outweigh Benefits for Uncomplicated Infections

The U.S. Food & Drug Administration (FDA) is warning that the risks associated with Cipro, including serious complications affecting the nerves, muscles, tendons and central nervous system, outweigh its benefits  for patients with certain uncomplicated infections. According to an alert issued in May 2016, the labels for Cipro and other fluoroquinolone antibiotics  will be updated with a new boxed warning. Read More

Complications Associated With Cipro

Cipro has been linked to some very serious complications, prompting the U.S. Food & Drug Administration (FDA) to issue several safety alerts in recent years for this and other fluoroquinolone antibiotics:

• 2004: Mention of peripheral neuropathy was added to the Warnings and Precautions sections of all fluoroquinolone labels. However, the revised labels characterized reports of peripheral neuropathy associated with the drugs as “rare cases.”
• 2008: The FDA ordered that a Black Box Warning – the most serious safety notice possible – be added to the labels of all fluoroquinolone medications, including Cipro. Patients may experience pain, swelling, or ruptures in the Achilles tendon (in the back of the ankle), as well as tendons in the shoulder, hand or elsewhere. People over 60, those taking steroids, or those who have had kidney, heart or lung transplants are most likely to experience tendon damage related to Cipro.
• 2013: The FDA ordered the manufacturers of Cipro and other fluoroquinolones to strengthen their labels’ peripheral neuropathy warnings to better describe the rapid onset of the condition, as well as its potential for permanence. The agency also asked for the removal of language that characterized the disorder as a rare occurrence.
• 2015: An FDA advisory panel votes to recommend stronger warnings for fluoroquinolone antibiotics in the treatment of sinus infections, urinary-tract infections and bronchitis that worsens existing chronic obstructive pulmonary diseases. Read More

Fluoroquinolone Litigation News

Since 2013, hundreds of lawsuits have been filed against the manufacturers of Cipro and other name-brand fluoroquinolones, all of which accuse Bayer and other defendants of failing to adequately warn doctors and patients about the potential for serious nerve damage and peripheral neuropathy. These complaints point out that the link between peripheral neuropathy and the use of these medications was recognized in 2001, when a study published in the Annals of Pharmacotherapy detailed 45 cases of the condition among people treated with the antibiotics. At least 84% of the cases were characterized as “severe,” while more than half persisted for a year or more.

In August 2015, the U.S. Judicial Panel on Multidistrict Litigation (JPML) transferred all federal peripheral neuropathy lawsuits involving fluoroquinolone antibiotics to the U.S. District Court, District of Minnesota. Centralization of the docket will improve judicial efficiency by allowing these cases to undergo coordinated pretrial proceedings. Read More