Levaquin, Cipro, Avelox Safety Issues To Be Discussed By FDA Advisory Committee

A panel of FDA advisors will meet early next month to review the benefits and safety issues with Levaquin, Avelox, Cipro and similar antibiotics, which have been linked to reports of permanent nerve damage and other serious health problems. 

The FDA posted a notice in the Federal Register earlier this month, announcing that a meeting of the Antimicrobial Drugs Advisory Committee will be held on November 5, at which time a panel of experts will review a popular class of antibiotics, known as fluoroquinolones.

Levaquin, Avelox and Cipro are all members of that class of drugs, which are used in a variety of infection treatments, including urinary tract infections, acute bacterial sinusitis and in patients with bronchitis linked to chronic obstructive pulmonary disease.

An increasing number of a serious safety issues with Levaquin and other fluoroquinolones have emerged in recent years, including a risk of long-term and debilitating nerve problems, known as peripheral neuropathy, as well as an increased risk of tendon ruptures.

Levaquin has been the best-selling fluoroquinolone antibiotic in recent years, generating more than $1.3 billion in annual sales before generic versions became available in 2011.

The advisory committee is expected to make recommendations to the FDA about what regulatory actions should be taken regarding the use and safety of antibiotics. While the recommendations are not binding, the agency usually weighs those recommendations heavily when deciding whether new warnings or restrictions should be placed on prescription medications.

In 2013, the FDA issued a drug safety communication to announce that it is requiring the manufacturers of Levaquin and other fluoroquinolones to change their warning labels about the risk of peripheral neuropathy problems, providing warnings for the first time that symptoms may continue for months or even years after an individual stops taking the drug.

While prior warnings suggested that it was rare of users to suffer a Levaquin neuropathy injury and that the problems often resolve once the medication is no longer used, fluoroquinolone antibiotics have actually been linked to a large number of reports involving permanent and disabling nerve damage that may last the rest of a user’s life.

In 2014, a study published in the medical journal Neurology added further support for these warnings, indicating that side effects of Levaquin and other fluoroquinolones may double the risk of peripheral neuropathy.

A growing number of Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits are now being pursued on behalf of users diagnosed with permanent nerve damage, alleging that the antibiotic manufacturers failed to adequately warn consumers and the medical community about the potential long-term risks of peripheral neuropathy.

In August, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all of the fluoroquinolone litigation pending throughout the federal court system before U.S. District Judge John R. Tunheim in the U.S. District Court for the District of Minnesota.

Given the similar questions of fact and law, the cases have been consolidated for pretrial proceedings to reduce the risk of duplicative discovery into common issues, avoid conflicting pretrial orders from different courts and to serve the convenience of the parties, witnesses and the courts.