It’s easy to lose track of important developments brought forth by the FDA these days. With the largest salmonella outbreak in the country’s history currently making news, some things that aren’t quite as media savvy, or sexy, get pushed to the side. This seems to be the case with the drug levofloxacin (trade name Levaquin), which was recently ordered to carry a “black box” warning by the Food and Drug Administration (FDA). A black box warning is the strongest warning the FDA will use, just short of a recall. This is because Levaquin has been tied to hundreds of tendon ruptures by users of the drug. What It Is Levaquin is part of a group of drugs known as quinolones, and manufactured by Ortho-McNeil Pharmaceuticals. It is used to treat serious cases of bacterial infections. It targets infections that affect skin, sinuses, lungs, and urinary tract, and works by killing or limiting bacteria so the body has a chance to fight it off. Levaquin is part of what is known as the third generation of quinolones, which means that its antibacterial spectrum is wider than those earlier generations, such as Cipro (another drug given a black box warning due to tendon ruptures). This drug has also been identified as one of the drugs that may be administered during anthrax poisoning. While the likelihood of an anthrax attack is extremely slim, government agencies began stockpiling it after the attacks of September 11th, 2001. This is a widely used, popular, and powerful antibiotic that has seen its fair share of success since it was approved by the FDA in 1997. However, it is also the suspected culprit in spontaneous tendon ruptures, especially among the elderly. These have been known to occur both during and after patients have used the drug. The danger of tendon ruptures is even greater when the drug is used in combination with certain steroids. While the Achilles tendon is the most prominent place to rupture, Levaquin is also reportedly linked to ruptures in the biceps, hand, shoulder, and thumb. Cases of tendonitis and other tendon-related problems have also been linked to this drug. There have reportedly been 794 cases of tendon ruptures tied to Levaquin and other quinolones between November 1997 and December 2005. The FDA believes that these cases may only comprise ten percent of adverse side-effects related to quinolones. The FDA was recently petitioned by the watchdog group Public Citizen to issue a warning. The agency finally did on July 8th. Spokespeople for Public Citizen have criticized the FDA and believe that hundreds of injuries could, and should, have been avoided had the FDA taken action earlier. Black box warnings are certainly an appropriate action to take at this juncture, and patients using Levaquin have been requested to see their doctor immediately and stop taking the drug by the FDA. If you are in the Boca Raton, Ft. Lauderdale, or West Palm Beach, Florida area, and you believe you have an injury associated with taking Levaquin, please contact the Glick Law Firm, P.A.
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