Warnings for Levaquin, Avelox, Cipro, Other Antibiotics Strengthened Again By FDA

Federal regulators have again strengthened warnings on the labels of a popular class of antibiotics known as fluoroquinolones, which includes Levaquin, Avelox, Cipro and other drugs, indicating that doctors should avoid prescribing the drugs for certain infections unless no other options are available. 

The FDA announced the antibiotic warning updates in a drug safety communication issued on July 26, indicating that additional information will be added to the existing “black box” label warning already carried by the drugs, which is the strongest label warning the agency can require.

The warning for Levaquin, Avelox, Cipro and other fluoroquinolone-based antibiotics will now indicate that the drugs should not be used for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, unless there are no other treatment options. The FDA warns that the risk of side effects from Levaquin and similar antibiotics outweigh the benefits in most of those cases, due to the risk of permanent side effects that can affect the nervous system, joints, tendons and muscles.

The label warnings, which include additional information to be added to the medication guide, were anticipated after the FDA advised doctors similarly in a safety communication in May.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”

The latest warning adds to a lengthy list of health concerns already highlighted on a black box, placed prominently on the label to alert users and doctors to the potential risks of tendinitis, tendon rupture, and worsening of myasthenia gravis. The drug’s label also warns of the risks of peripheral neuropathy associated with the antibiotics, as well as central nervous system side effects, hypersensitivity reactions, heart problems and skin problems.

Aortic Aneurysm and Aortic Dissection Risks

The label warnings come amid emerging data about a new risk associated with use of the drugs, after a recent study found users may also face an increased risk of suffering an aortic aneurysm or aortic dissection.

Aortic aneurysm is a painful and potentially serious condition involving a bulge in the aorta, where the walls of the artery have weakened. They can cause severe chest pain, as well as carry the risk of rupturing. Aortic dissections are similar, but potentially more serious and life-threatening condition, involving degradation within the layers of the aorta. Both pose a serious health risk and usually require invasive surgery to treat.

In October 2015, only weeks before the FDA advisory meetings on fluoroquinolones, a study published in the medical journal JAMA Internal Medicine found that current use of Levaquin, Avelox or a similar antibiotic was associated with a two-fold increased risk of suffering an aortic aneurysm or dissection injury.

Researchers suggested that the same side effects that cause the antibiotics to degrade tendons and other connective tissue in the body may result in problems with aortic dissections and aneurysms. It does not appear that these findings were considered by the FDA advisory panel convened last year to evaluate the safety of fluoroquinolones, or weighed in the recent FDA decision to add new warnings that called for restricted use of the medications.

It is possible that these concerns could lead to yet another FDA safety review, and, if verified, could lead to additional label warnings, or potentially even a recall for Levaquin, Avelox, Cipro and other fluoroquinolones, if the agency determines that the cumulative risks outweigh the potential benefits over other available treatments.

In late June, the Institute for Safe Medication Practices (ISMP) issued a report indicating that Levaquin and Cipro were linked to a large number of adverse event reports in 2015, which warned that the drugs were linked to disabling side effects.

The ISMP reports that there were 489 cases of persistent adverse side effects linked to the use of Levaquin that were reported to the FDA last year, and 366 cases of persistent adverse effects linked to Cipro. In this case, persistent effects is defined as those effects that continue even after the patient has stopped taking the drug.

In recent years, thousands of Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits have been filed by individuals throughout the United States who have suffered debilitating injuries while using the medications, including peripheral neuropathy and tendon ruptures. The complaints allege that the drug makers failed to adequately warn about the risks associated with the medications, withholding information from consumers and the medical community.

With the emergence of this recent new risk information, potential aortic aneurysm lawsuits and aortic dissection lawsuits are also being pursued by lawyers for individuals and families of those who may have died after using a fluoroquinolone antibiotic.

The lawsuits allege that individuals throughout the U.S. were unnecessarily exposed to the serious health risks due to fluoroquinolone antibiotics, indicating that the drug makers placed their desire for profits before consumer safety by promoting the drugs for a variety of common infections, while failing to warn about the risk of aortic aneurysm, aortic dissection, peripheral neuropathy and other problems.