Fluoroquinolones Safety Label Updates

The Food and Drug Administration required fluoroquinolone safety label updates in 2008 due to adverse health reactions linked to the drug. The black box warning label is the Food and Drug Administrations strongest warning label and it now appears on all fluoroquinolone packages. It advises consumers and medical professionals about the possible increased risk of the development of tendon injuries after taking fluoroquinolones.

Fluoroquinolones safety label infographic

Reasoning Behind Safety Label Updates

The Food and Drug Administration believes that the fluoroquinolone safety label updates will strengthen the warnings that already exist regarding this medication. This means that popular fluoroquinolone antibiotics such as Cipro, Levaquin, Noroxin, Floxin, and Avelox all bare the new black box warning label. Plus, all fluoroquinolone antibiotics will be required to have a medication guide included with the warning label.

Severe Side Effect of Fluoroquinolones

The fluoroquinolone safety label updates came after multiple sources linked tendon ruptures and tendonitis to fluoroquinolone antibiotics. This led consumer groups to petition the FDA for changes to the fluoroquinolone safety label. Some say the FDA did not act quickly enough, leading one consumer advocacy group to file a lawsuit against them.

Disputes Over Safety Label Verbiage

All of the manufacturers of fluoroquinolone antibiotics have responded to the requirement for fluoroquinolone safety label updates. However, many consumer advocacy groups feel that the warning lacks the proper verbiage to convey the seriousness of the risk. One expert says that the risk of tendonitis or tendon rupture increases by three to four times when a person is taking fluoroquinolone antibiotics. Furthermore, those risks are said to increase even more for elderly patients.

Consumer advocacy groups have called for additional changes to the existing fluoroquinolone safety labels. They would like the medical community to be educated by the FDA on the fluoroquinolone risks. To date no new changes have been made to the existing black box warning label on fluoroquinolone antibiotics.

Consult a Lawyer

If you or a loved one has been harmed by the use of Fluoroquinolones, you should contact a Fluoroquinolones attorney to find out whether you are eligible for compensation for your injuries or hardship.