Levaquin Side Effect Prompts Black Box Warning

Two leading antibacterial drugs have come under increased scrutiny by the Food and Drug Administration following reports of serious injury linked with their use. Levaquin and Cipro, manufactured by Ortho-McNeil and Bayer respectively, are known as flouroquinolones, a class of commonly used antibacterial drugs. Although the FDA warning is directed towards all drugs from the flouroquinolone family, Levaquin and Cipro have been singled out because of their popularity.

Levaquin Black Box Warning

In an effort to alert consumers and doctors about the potential side effects associated with the use of Levaquin and other flouroquinolones, the FDA has issued a black box warning, the most urgent and severe type of safety warning imposed by the agency. Black box warnings 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 Levaquin, Cipro and other flouroquinolones. Public Citizen believes that the FDA acted late in issuing a black box warning, essentially keeping flouroquinolone users at risk of injury.

The FDA has been quick to point out that flouroquinolone drug labels already warn 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.

Levaquin Tendon Rupture Risks

Levaquin and other flouroquinolones have been linked with tendon rupture injuries. Tendon injuries most often result from some type of trauma or over-activity. Experts studying the link between flouroquinolones and tendon rupture remain 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 flouroquinolone use, though Public Citizen has reported that the number exceeded 400 people in 2007 alone.

Tendon tissue is located throughout the body; however, the most common tendon linked with flouroquinolone-based rupture is the Achilles tendon. Reports indicate that the injury often occurred without pain or warning, suggesting a potential toxicity issue. Typically, flouroquinolone injury victims reported pain and swelling prior to rupture, leading experts to believe that injury may be avoidable in such instances by halting use of the drug.

Flouroquinolone users facing an increased risk of tendon rupture include people aged 60 and over, people taking steroids and heart, lung or kidney transplant recipients.

Levaquin Lawsuits

If you or a loved one has been injured as a result of using Levaquin, Cipro or another flouroquinolone, 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 law offices of Aylstock, Witkin, Kreis and Overholtz boast some of the most experienced personal injury lawyers Pensacola, Florida has to offer. 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 drugs. Contact AWKO law today at 888 255 2956 today to get more information regarding your rights as a Levaquin injury victim.