Side Effects of Levaquin, Similar Antibiotics Linked To Insomnia Risks: ISMP Report

A recent report warns that the side effects of Levaquin, Avelox and Cipro have been linked to a large number of adverse event reports over the past year involving insomnia.

In the latest edition of the Institute for Safe Medication Practices (ISMP)’s Quarterwatch report (PDF), which independently analyzes adverse event reports submitted to the FDA, the group identified 87 different drugs that appear to induce insomnia; one of the most common drug side effects. However, the findings also found an unexpected correlation between a class of antibiotics known as fluoroquinolones and insomnia as well.

While many of the drugs on the list were expected to have insomnia side effects, such as drugs used to treat attention deficit and hyperactivity disorder, and smoking cessation drugs, like Chantix, no other antibiotics were linked to insomnia problems.

According to the findings, over the course of a year, ending in June 2016, the FDA received 1,811 reports of either insomnia or difficulty sleeping associated with Levaquin, 1,252 such reports linked to the use of Cipro, and 279 reports associated with Avelox. Each of the antibiotics are part of the same class of medications, known as fluoroquinolones, which are widely used, but have been linked to an increasing number of side effects and health risks in recent years.

“Only one of the many classes of antibiotics were implicated–fluoroquinolones such as ciprofloxacin (CIPRO), levofloxacin (LEVAQUIN), and moxifloxacin (AVELOX),” the report notes. “These antibiotics are also implicated in other neurological adverse effects.”

Those other side effects linked to the antibiotics include reports of peripheral neuropathy, a form of serious nerve damage that has been found to cause problems long after the medication is no longer used.

While the medications have been prescribed for a variety of different infections in recent years, use of the antibiotics has been curtailed over the past year as more information has become available about the risk of peripheral neuropathy and other health problems linked to the drugs.

In August 2013, the FDA required the makers of Levaquin and other fluoroquinolones to provide stronger warnings about the peripheral neuropathy risk with the antibiotics, adding information to the label for the first time that suggested problems may last for months or years after an individual stops taking the drug. The new label now warns patients to contact their doctors and consider switching to a different class of antibiotics if they experience symptoms of peripheral neuropathy. The FDA also no longer allows the drug manufacturers to claim that the condition is rare on the warning labels.

Given the side effects linked to the antibiotics, the FDA issued a new drug safety communication in May 2016, urging doctors not to prescribe fluoroquinolones for many common infections that are uncomplicated and have other available treatment options, indicating that the potential risks outweigh the benefits. The federal regulatory agency considered available information on the risk of peripheral neuropathy, tendon ruptures, retinal detachments and other health concerns linked to the drugs at that time.

There are currently hundreds of Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits filed throughout the federal court system over peripheral neuropathy problems allegedly caused by the antibiotics.

More recently, research has also suggested that fluoroquinolones may cause severe collagen degradation issues that impact the aorta. As a result, a growing number of aortic aneurysm lawsuits and aortic dissection lawsuits are also being pursued by former users of Levaquin and Avelox, alleging that the painful and potentially life-threatening complication may have been avoided if proper warnings had been provided to users of the antibiotics.