A South Carolina doctor is pushing federal regulators to issue a new warning on what he claims are devastating Levaquin side effects: adverse psychiatric events.
According to a report from 6ABC in Indianapolis, Dr. Charles Bennett petitioned the U.S. Food & Drug Administration (FDA) to update Levaquin’s black box label in September 2014. To date, the popular antibiotic has been linked to more 31,000 adverse event reports, including hundreds of cases involving depression and anxiety.
Levaquin has also been implicated in 122 suicides.
The report did acknowledge that the labels for Levaquin and other fluoroquinolone antibiotics include some warnings regarding insomnia, anxiety and depression. However, that information is only noted in the fine print buried deep within the package inserts. A black box warning – the strongest possible safety alert – is far more prominent and more likely to be seen by those taking the drugs.
The FDA has not yet responded to Dr. Bennett’s petition, and it could be several more years before it does.
“The FDA is carefully reviewing available scientific information and will determine appropriate actions when this review is complete,” the agency responded when asked why it was taking so long.
Levaquin and other fluoroquinolone antibiotics are prescribed to more than 22 million people annually to treat pneumonia and other bacterial infections. While popular, the drugs have been linked to a wide range of side effects.
In 2008, for examples, fluoroquinolone labels were updated with a black box warning regarding a risk of tendon injuries, including ruptures of the Achilles tendon.
In August 2013, the FDA ordered the manufacturers of oral and injectable fluoroquinolones to update the labels’ “Warning and Precautions” section to note a possible link to a serious and often permanent form of nerve damage called peripheral neuropathy. While information about the condition was added all fluoroquinolone labels in 2004, the agency determined that the prescribing information did not reflect the possible rapid onset of the condition, or the potential for permanent nerve damage.
The fluoroquinolone black box warning was updated in May 2016, this time to caution against their use in patients suffering from sinusitis, bronchitis and uncomplicated urinary tract infections when other options are available. The warning followed an agency review that suggested fluoroquinolones could cause multiple and permanent side effects involving the tendons, muscles, joints, nerves and central nervous system.
Hundreds of plaintiffs have filed lawsuits involving Levaquin, Cipro and Avelox after allegedly developing peripheral neuropathy related to the medications. The majority of these claims have been centralized in a federal litigation underway in the U.S. District Court, District of Minnesota.
In November 2012, Johnson & Johnson and its Janssen Pharmaceuticals reached Levaquin settlements in more than 800 cases involving the drug’s alleged association with tendon injuries and ruptures.
Other recent Levaquin lawsuits have involved accusations that the medication can cause serious aortic injuries, including aortic dissection and aortic aneurysm.