Cipro Side Effect Prompts Black Box Warning

Two leading brands of potent antibacterial drugs have come under increased scrutiny by the Food and Drug Administration following reports of serious injury linked with their use. Cipro and Levaquin – manufactured by Bayer and Ortho-McNeil respectively – are part of a class of antibacterial drugs known as fluoroquinolones. Although the FDA warning is directed towards all drugs from the fluoroquinolone family, Cipro and Levaquin have been directly targeted due to their popularity.

Cipro Black Box Warning

In an effort to alert consumers and doctors about the potential side effects associated with the use of Cipro and other fluoroquinolones, the FDA has issued a black box warning. Black box warnings are the most urgent and severe safety warnings imposed by the FDA and are designed to serve as a highly noticeable alert for drug users.

The FDA issued the black box warning following intense pressure from the consumer advocacy group Public Citizen. The organization petitioned the FDA for nearly two years following reports of tendon rupture risks associated with the use of Cipro, Levaquin and other fluoroquinolones. Public Citizen believes that the FDA acted late in issuing a black box warning, putting countless numbers of fluoroquinolone users at risk of injury.

Although acquiescing to Public Citizen’s efforts, the FDA pointed out that the drug labels already warned of a potential tendon injury risk associated with use of the drug. The black box warning was issued in conjunction with the development of new literature emphasizing the tendon injury risk as a measure intended to fully underscore this warning.

Cipro Tendon Rupture Risks

Cipro and other fluoroquinolones have been linked with tendon rupture injuries. Tendon injuries typically result from over-activity or trauma. Experts studying the link between fluoroquinolones and tendon rupture are unclear as to the exact nature of the side effect, though research is ongoing.

The FDA has not released a specific number of people injured through fluoroquinolone use; however, Public Citizen has reported the number exceeded 400 people in 2007 alone. The most common tendon linked with fluoroquinolone-based rupture is the Achilles tendon. Reports indicate that the injury often occurred without previous pain or warning, suggesting a potential toxicity issue faced by certain individuals. Typically, fluoroquinolone injury victims reported pain and swelling prior to rupture, leading experts to believe that injury could be avoided in such instances by halting use of the drug.

Fluoroquinolone users facing an increased risk of tendon rupture include:

  • People aged 60 and over.
  • People taking steroids.
  • Heart, lung or kidney transplant recipients.

Cipro Lawsuits

If you or a loved one has been injured as a result of using Cipro, Levaquin or another fluoroquinolone, you may be entitled to compensation. Drug manufacturers have a responsibility to ensure the safety and efficacy of their products before marketing them for public consumption. Failure to adequately measure a drug’s effects or alert doctors and consumers to any potential side effects is considered negligent and grounds for personal injury litigation.

The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. The lawyers and staff representing AWKO Law are experts in handling cases of negligence by large drug companies. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by defective drugs. Contact AWKO law today at 888 255 2956 today to get more information regarding your rights as a Cipro injury victim.