Fluoroquinolone Antibiotic Side Effects Warrant Stronger Warnings: FDA Panel

A panel of drug and health experts have voted overwhelmingly to recommend that a popular class of antibiotics, including Levaquin, Avelox and Cipro, carry more stringent warnings about a “constellation” of potentially disabling side effects that can include nerve damage, tendon ruptures and heart problems. 

The votes came following impassioned testimony by dozens of patients who suffered peripheral neuropathy from fluoroquinolone antibiotics, which is a severe form of nerve damage that may continue long after the medications are used. Other testimony was presented involving individuals who suffered Achilles tendon ruptures and other problems after using the medications for infections that may have resolved on their own.

Levaquin, Avelox and Cipro are among the most widely used members of a controversial class of antibiotics, known as fluoroquinolones, which are used in a variety of infection treatments, including urinary tract infections, acute bacterial sinusitis, bronchitis linked to chronic obstructive pulmonary disease and other conditions.

FDA reviewers raised concern about a cluster of apparently related side effects of Levaquin and other related antibiotics, which they labeled Fluoroquinolone-Associated Disability (FQAD).

According to documents submitted by FDA officials before the panel meetings, the fluoroquinolone problems occur when previously healthy individuals take one of the drugs and suffer two or more adverse events, such as peripheral neuropathy, musculoskeletal problems, heart problems, skin problems or conditions that negatively impact their senses. These problems result in disability or significant disturbance of normal life function.

Fluoroquinolone Risks Require Stronger Warnings

The review and the hearing come as a growing number of individuals throughout the U.S. are now filing a Levaquin lawsuits, Avelox lawsuits or Cipro lawsuits after being diagnosed with peripheral neuropathy, alleging that the drug makers failed to adequately warn about the long-term risk of users suffering the nerve damage.

The FDA panel looked specifically at the safety of the antibiotics when they are used to treat sinus infections, urinary tract infections, and chronic obstructive pulmonary disease (COPD) worsened by bronchitis. The panel voted 21-0 to strengthen the drugs’ warning labels for treatment of sinusitis, 20-1 on urinary tract infections, and 18-2, with one abstention for strengthening the indications for bronchitis.

Experts warned that almost everyone in the U.S. would take a fluorquinolone to treat an infection at some point in their lives. An estimated 36 million prescriptions for Levaquin, Avelox, Cipro and their generic counterparts were distributed in 2014.

While the advisory committees’ recommendations are not binding on the FDA, the agency often factors those recommendations heavily in any regulatory decisions about whether to strengthen label warnings, remove medications from the market or limit use of the drugs.

Antibiotic Nerve Damage Risks

Levaquin, Avelox and Cipro are among the most widely prescribed antibiotics in the United States, generating billions in annual sales.

In 2013, the FDA issued a drug safety communication to announce that it was 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 of nerve damage may continue for months or even years after an individual stops taking the drug.

Prior warnings suggested that peripheral neuropathy was a rare risk for users of Levaquin, Avelox and Cipro, and indicated that the problems often resolve once the medications are no longer used. However, many users have been left with a long term and permanent Levaquin neuropathy injury, leading the FDA to require warnings about the permanent nature of the nerve damage in many cases.

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