Fluoroquinolone Injuries are Among the Most Frequently Reported Drug Side Effects

According to a new report, antibiotics in the same class as Avelox (moxifloxacin) were the drugs most frequently associated with reports of persistent adverse effects in 2015.

The report appeared in QuarterWatch, a publication of the Institute for Safe Medication Practices. QuarterWatch reviews reports made to the Food and Drug Administration (FDA) about adverse events related to drugs.

In its annual report issue covering reports from 2015, the ISMP found that fluoroquinolone antibiotics like Avelox, Cipro, and Levaquin were the class of drugs most often associated with persistent adverse effects that became long-term health issues.

Fluoroquinolone antibiotics accounted for the largest number of reports of persistent adverse effects (n = 855) that became long-term health issues. The total included 489 (57%) for Levaquin and 366 (43%) for Cipro. The persistent adverse effects described most often were painful joint, muscle, and tendon disorder, according to QuarterWatch. In 65 percent of the reported cases, the effects were said to be disabling.

The six fluoroquinolone antibiotics approved by the FDA are the most widely prescribed antibiotics in the U.S. The ISMP report notes that in the fourth quarter of 2015 alone, Cipro and Levaquin accounted for more than 9 million prescriptions. Annually, fluoroquinolones account for about 26 million prescriptions in the U.S.

Fluoroquinolones have been associated with side effects that may persist after the patient stops using the drug. Reported fluoroquinolone injuries include aortic aneurysm or aortic dissection, peripheral neuropathy, or tendon ruptures. Some of these injuries can leave patients permanently disabled.

The FDA issued a fluoroquinolone warning in May 2016 to address the problem of these injuries and side effect. In weighing the side effects, the FDA concluded that the risk of serious side effects generally outweighs the benefits of fluoroquinolones for treating conditions such as chronic bronchitis, earaches, sinusitis, and uncomplicated urinary tract infections. The FDA recommends that doctors prescribe fluoroquinolones for patients with more serious infections like anthrax, plague and pneumonia, according to Law360. For milder infections, fluoroquinolones should be used only when there is no other treatment alternative.

The May communication ordered drug makers to add new safety information to the labels for fluoroquinolones. The agency says it will continue to investigate the issue and will update the public with essential information as it becomes available.

A 2014 article in the journal Clinical and Translational Allergy reported on case studies associating fluoroquinolones with Stevens-Johnson syndrome, a serious skin reaction to medications. Patients with Stevens-Johnson develop a blistering rash that spreads across the body. The skin sheds or peels away, sometimes exposing large portions of the body surface area to infection. People with SJS often must be treated in a hospital burn unit. They can suffer permanent damage and disfigurement. SJS can affect the eyes, causing corneal scarring that can put the patient at risk for blindness.

Hundreds of product liability lawsuits involving fluoroquinolone side effects are moving toward trial in a multidistrict litigation in federal court in Minnesota. The plaintiffs claim that the manufacturers of Levaquin, Cipro and Avelox failed to warn doctors and patients about the potential for peripheral neuropathy and other serious side effects.




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