Aortic Aneurysm Risks from Levaquin, Avelox Could Push FDA to Require Even Stronger Warnings for Antibiotics

Although the FDA recently warned that side effects of Levaquin, Avelox and other fluoroquinolone-based antibiotics make the drugs too dangers to treat many common infections, it may be necessary for the federal drug regulators to add even stronger warnings as more information is learned about the potential aortic aneurysm risk with the antibiotics. 

For years, fluoroquinolones have been among the most widely used antibiotics in the U.S., including popular drugs like Levaquin, Cipro, Avelox, Floxin, Noroxin and generic equivalents, which have been used by millions of Americans. The drugs have commonly been prescribed to treat a variety of infections, including acute sinusitis, acute bronchitis, urinary tract infections and other conditions.

In May, the FDA issued a drug safety communication about the risks associated with the antibiotics, indicating that “disabling and potentially serious side effects” associated with fluoroquinolones outweigh any benefits provided in using the drugs to treat uncomplicated infections, requiring the drug makers to add new warnings for doctors to indicate that the drugs should not be used to treat such infections, unless there are no alterantive treatments available.

That warning was based on an FDA evaluation into the known risks associated with the antibiotics, which included data on tendon ruptures, bone fractures, a form of permanent nerve damage known as peripheral neuropathy and other side effects, according to the agency. However, the drugs have also recently been linked to increased risks of aortic aneurysm and aortic dissection, which the FDA did not include in its most recent warning.

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.