FDA Mandates Warning Labels on Levaquin Packaging

In July of 2008, the U.S. Food and Drug Administration (FDA) mandated that Bayer, the manufacturer of Levaquin, place highly visible warning labels on the Levaquin package. These warning labels were required to inform consumers about the potential risks of using the drug, including the fact that serious injury to the tendons could occur. Bayer was also required to inform pharmacists and physicians of the increased risk of injury.

The FDA did determine that many of the injuries could have been avoided if individuals who felt pain stopped taking the drug and consulted with their personal care physician after experiencing symptoms. However, the people who did not feel pain before tendonitis or tendon rupture occurred could not have foreseen a negative outcome.

It was not until a public outcry erupted that the FDA decided to mandate warning labels on Levaquin. A consumer watchdog group called Public Citizen is the group that lobbied for FDA action. The group worked for more than two years in order to get the FDA to comply with their demands. Public Citizen is still working hard to get more warning labels mandated. There are complaints that the agency is taking too long to act, allowing more unnecessary injuries to occur.

What You Can Do

While some of the injuries sustained due to Levaquin use could have been avoided, it does not validate the necessity of being compensated for injury. Individuals who have sustained a tendon rupture may be able to exercise legal rights to help pay for medical expenses and other damages.

The Pulaski and Middleman law firm have put together an experienced team to help those who want to explore their legal options as a Levaquin tendon injury victim. To contact them for a free consultation, call 1-800-223-3784 or fill out the contact form provided.