Levaquin (levofloxacin) is a drug belonging to a class of antibacterial medications called fluoroquinolones. Manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Levaquin is used to treat a wide range of bacterial infections. It is one of the most popular drugs on the market for the treatment of urinary tract infections (UTIs).
Unfortunately, Levaquin has also been found to cause tendon problems and other complications in some patients. Thanks to the concerted efforts of consumer advocates and others over a span of more than 10 years, in 2008 the U.S. Food and Drug Administration (FDA) finally mandated the inclusion of a "black box warning" on the packaging of Levaquin and other fluoroquinolones.
In the interim, hundreds if not thousands of people suffered painful tendon injuries. Lawsuits against Ortho-McNeil-Janssen and other manufacturers allege that these companies should have done more to protect the public. If you or a loved one has suffered a tendon-related injury you believe may be related to Levaquin, contact a lawyer who can evaluate your case and determine whether you may be able to gain compensation for your personal injury.
Levaquin Black Box Warning
Although most side effects of Levaquin are rare, some can be quite serious. In 2008, reports of tendinitis, tendon rupture and other tendon-related conditions led the U.S. Food and Drug Administration (FDA) to issue a Public Health Advisory warning doctors and patients of these risks. In addition, the FDA required Ortho-McNeil-Janssen to add a black box warning to the packaging of Levaquin.
The FDA's actions came shortly after a lawsuit was filed by consumer advocacy group Public Citizen, which for years had attempted to convince the FDA to issue stronger warnings about the side effects of Levaquin and other fluoroquinolones.
The following is a synopsis of this struggle:
- Public Citizen petitions FDA for sterner warnings (1996). Following a flurry of reports of tendon conditions in patients taking fluoroquinolones, Public Citizen petitioned the FDA, requesting that stronger warnings be issued. In its petition the group cited inappropriate promotion of these drugs by their manufacturers and distributors.
- Illinois Attorney General's office petitions the FDA requesting black box warnings (2005). The FDA declines to issue the requested warnings.
- Public Citizen and Illinois Attorney General's office combine forces, again petitioning the FDA to require black box warnings, as well as the development of Medical Guides for fluoroquinolones (2006). Still the FDA fails to take the requested actions.
- Public Citizen sues the FDA, citing hundreds of reported cases of tendon rupture and other injuries related to Levaquin and fluoroquinolones (2008). The FDA finally requires the manufacturers of these drugs to add black box warnings to the packaging of their products. In addition, the requested Medical Guides are developed.
During this lengthy battle, the manufacturers of Levaquin and other fluoroquinolones were fully aware of their drugs' side effects but chose not to take aggressive action to warn consumers. If you sustained a tendon injury while taking Levaquin, contact a personal injury attorney today.
Levaquin Side Effects
Most side effects of Levaquin are rare. Nevertheless, some of these conditions can be serious. The most common Levaquin side effects, occurring in more than 3 percent of participants in U.S. clinical trials, are the following:
The FDA's mandated black box warning for Levaquin stems from reports of tendon injuries. Other side effects include allergic reactions, central nervous system disorders, anxiety, abnormal heart rhythm, photosensitivity (sensitivity to the sun), blood glucose "disturbances," hepatotoxicity (liver damage), changes in sensation and nerve damage.
Reports of tendon-related conditions associated with fluoroquinolones go back as far as the 1980s, and consumer advocates have been fighting for stronger warnings for more than 10 years.
Many of the people who have suffered tendon injuries after taking Levaquin have sued the manufacturer, Ortho-McNeil-Janssen Pharmaceuticals. While it may be true that fluoroquinolone manufacturers have acted negligently, it is not necessary to prove this in order to receive compensation for your injuries. Under pharmaceutical and product liability laws, a company's role in the manufacture or distribution of bad medicine is sufficient to hold the company liable. To determine whether you have a good chance of receiving compensation, you will need to seek personal injury legal help with an attorney who can assess your case and evaluate claims for defective products.
Patients over 60 years of age, as well as those who have had a kidney, lung or heart transplant, are at increased risk of developing tendon-related conditions when taking Levaquin.