Fluoroquinolone Risks Outweigh Benefits for Common Infections: Consumer Reports

A major consumer watchdog group warns that a popular class of antibiotics known as fluoroquinolones, which include Levaquin, Cipro, Avelox and other blockbuster drugs, are too dangerous to justify using them to treat common infections, calling for the medical community to scale back on use of the antibiotics. 

On March 7, Consumer Reports issued a warning about fluoroquinolone risks, amid concerns that the widely used drugs may increase the risk of a permanent form of nerve damage, known as peripheral neuropathy, as well as tendon damage and other potentially serious side effects.

Consumer Reports indicates that the antibiotics are “too risky for common infections,” noting that the Infectious Diseases Society of America has called for the medications not to be used in mild, common infections like bronchitis, sinus infections, and urinary tract infections. Those three illnesses account for nearly one-third of all fluoroquinolone prescriptions, according to the report.

The group also notes that in November, an FDA advisory panel also cautioned against casual use and called for stronger label warnings.

Patients should be made more aware of the potential risks of fluoroquinolone antibiotics, according to Consumer Reports, which urges doctors to no longer prescribe the drugs for these common infections.

Levaquin, Avelox and Cipro are among the most widely used 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.

At the November hearing, FDA reviewers raised concerns 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.

Peripheral Neuropathy Litigation

There are currently at least 425 Levaquin lawsuits, Cipro lawsuits and Avelox lawsuits pending throughout the federal court system involving claims that consumers suffered debilitating nerve damage after using the fluoroquinolones, alleging that the drug makers failed to adequately warn about the link between use of the antibiotics and peripheral neuropathy.

As lawyers continue to review and file cases, it is ultimately expected that several thousand complaints will be filed by former users of Levaquin, Avelox and Cipro who now suffer permanent nerve injury.

Given the common questions of fact and law raised in the case, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for the lawsuits last year, centralizing complaints filed nationwide before U.S. District Judge John R. Tunheim in the District of Minnesota to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges and serve the convenience of the parties, witnesses and the courts.

The fluoroquinolone litigation has emerged since the FDA required new warnings for all antibiotics in the calss in August 2013.

While prior warnings provided with drugs like Levaquin, Avelox and Cipro indicated that some users experienced temporary nerve damage in rare cases, the FDA required the manufacturers of all fluoroquinolone antibiotics to provide stronger indication that the medications may cause long-lasting nerve injury, which may last for months or even years after an individual stops taking the antibiotic.

Peripheral neuropathy involves damage to the nerves that may impair sensation, movement and other aspects of health. This may leave users with persistent pain, burning, tingling, numbness, weakness and sensitivity to light touches, temperature and motion in the arms and legs, as well as other problems that cause a major disruption to daily activities.

Plaintiffs allege that the makers of Levaquin, Avelox and Cipro should have provided these warnings years ago, noting that the first indication of a possible link between long-term peripheral neuropathy and fluoroquinolone antibiotics came in a study published in 2001.

If adequate warnings had been provided about the risk of permanent neuropathy problems, plaintiffs indicate that they may have avoided painful and debilitating injuries.