Levaquin Label Updated With New Black Box Warning

Published on July 27, 2016 by Sandy Liebhard

Federal drug regulators announced yesterday that the labels for Levaquin and other fluoroquinolone antibiotics have been updated with new information regarding their potential to cause a wide array of debilitating side effects.   All drugs in the class, including Levaquin, Cipro, Avelox, Factive and generics, now bear a revised black box warning stating that they should not be used for sinus infections, bronchitis and simple urinary tract infections.

The Warnings and Precautions section of all fluoroquinolone labels have also been revised with information regarding the risk of disabling and potentially irreversible adverse reactions.

The U.S. Food & Drug Administration (FDA) announced its intention to modify fluoroquinolone labels in May, after a safety review confirmed that both oral and injectable versions are associated with serious complications involving tendons, muscles, joints, nerves and the central nervous system.

“These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent,” the FDA said in a statement issued on July 26^th.

According to the agency, drugs like Levaquin should be reserved for potentially fatal infections such as plague, anthrax and some types of bacterial pneumonia.

Previous Fluoroquinolone Safety Alerts

This is not the first time that safety concerns have prompted the FDA to modify fluoroquinolone labels. In 2008, a black box warning regarding tendinitis and tendon ruptures was added to the labeling, after an evaluation suggested that patients using the drugs faced an increased risk for these complications.

In 2013, the FDA ordered  fluoroquinolone manufacturers to include stronger warnings regarding a potential association with peripheral neuropathy and permanent nerve damage. While mention of these side effects was initially added to the drugs’ labels in 2004, the agency determined that the wording did not reflect the rapid onset of symptoms, as well as the potential for permanent nerve damage.

Fluoroquinolone Litigation Moving Forward

Court records indicate that more than 400 Levaquin lawsuits and other product liability claims involving Cipro and Avelox are pending in a federal multidistrict litigation now underway in the U.S. District Court, District of Minnesota. Dozens of similar claims are pending in state courts around the country. All of the lawsuits were filed on behalf of patients who allegedly developed peripheral neuropathy due to their use of the antibiotics, and accuse the drugs’ manufacturers of failing to warn patients and doctors about this potential risk.

According to documents issued earlier this month in the District of Minnesota, the fluoroquinolone litigation is planning to convene a Science Day in September. The event will provide the parties with an opportunity to brief the Court on the medical, scientific and regulatory issues relevant to the litigation in an objective, and non-adversarial manner.