Side Effects of Levaquin, Similar Antibiotics Make Them Too Dangerous To Treat Some Infections: FDA

Amid continuing concerns about serious health risks associated with fluoroquinolone-based antibiotics, federal regulators now indicate that the side effects of Levaquin, Avelox, Cipro and other similar medications are so dangerous that the drugs should not be prescribed to treat many common types of infections.

In a drug safety communication issued on May 12, the FDA warn that a class of antibiotics called fluoroquinolones carry a risk of “disabling and potentially serious side effects,” indicating that risks outweigh any benefits provided in using the drugs to treat uncomplicated infections.

The agency indicates that Levaquin, Avelox, Cipro and similar drugs will now carry warnings on the label and Medication guides indicating that they should not be prescribed to treat sinusitis, bronchitis or uncomplicated urinary tract infections, unless there are no alternative treatments available.

The new warnings come following an FDA safety review, which found that systematic use of fluoroquinolones were linked with permanent side effects that can include permanent nerve damage known as peripheral neuropathy, tendon ruptures and other health risks. Recent studies have also suggested a potential risk of aortic aneurysm and aortic dissection with Levaquin, Avelox and Cipro.

The fluoroquinolones are among the most widely used antibiotics in the U.S., and are commonly prescribed to treat a variety of infection treatments, including urinary tract infections, acute bacterial sinusitis, bronchitis linked to chronic obstructive pulmonary disease and other conditions.

At an advisory committee hearing in November, FDA reviewers raised concerns about a cluster of apparently related side effects associated with the 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 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.

In addition, more recent concerns have arisen following a study published in October 2015, which links the use of Levaquin and similar antibiotics to an increased risk of aortic aneurysm and aortic dissection. Both conditions can result in a rupture of the aorta, resulting in internal bleeding, severe injury and can be fatal.

Aortic aneurysms are a bulge in the aorta where the walls of the artery have weakened. They can cause severe chest pain as well as carrying the risk of rupturing. Aortic dissections are similar, but occur within the layers of the aorta and are far more life-threatening. Both usually require invasive surgery to treat.

The FDA is advising patients to contact their health care professionals immediately if they experience serious side effects while taking these drugs. Symptoms of concern can include tendon, joint and muscle pain, “pins and needles” sensations, confusion and hallucinations. The symptoms of aortic dissection and aortic aneurysm generally include a tearing pain in the upper chest or back, but the FDA has not yet advised on that particular risk.

The agency has asked doctors to stop use of the antibiotics if a patient reports serious side effects and to switch to a non-fluoroquinolone antibiotic to complete the patient’s treatment.

Cipro, Avelox and Levaquin Litigation

There are currently hundreds of 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. A growing number of users are now considering potential aortic aneurysm lawsuits and aortic dissection lawsuits after suffering these injuries recently linked to the medications.

Given the common questions of fact and law raised in the pending peripheral neuropathy cases, 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. It is unclear whether the aortic aneurysm and dissection cases would be included in the MDL as complaints are filed in the coming months and years.

Plaintiffs allege that the drug makers have actively withheld information about the potential risks associated with the popular antibiotics, encouraging doctors to prescribe the medications for conditions that cause individuals to be unnecessarily exposed to a risk of serious and debilitating injuries.