Though Avelox and other fluoroquinolone antibiotics have been linked to thousands of adverse events, a new report suggests that doctors, pharmaceutical companies and researchers have made little effort to understand the side effects associated with these popular medications.
Fluoroquinolones, which include drugs like Avelox, Cipro and Levaquin, among others, have been around since the 1980s. In 2015, doctors in the United States wrote more than 32 million prescriptions for the drugs, making them the fourth-most popular class of antibiotics.
Over the years, the U.S. Food & Drug Administration (FDA) has issued numerous safety alerts for fluoroquinolone antibiotics, including warnings about peripheral neuropathy and tendon damage. In 2015, an agency review confirmed that the drugs could cause multiple and potentially permanent side effects involving the tendons, muscles, joints, nerves and central nervous system.
Yet despite these known risks, the medical community has made little effort to understand why fluoroquinolone antibiotics have proven toxic to thousands of people. According to a report published in the March issue of Nature, the reasons for this troubling situation are complex.
For one thing, there’s little financial support available for research involving older medications. Because it’s not a priority for National Institutes of Health and other research agencies, drug makers have no incentive to fund fluoroquinolone studies.
Even more disturbing, scientists are often reluctant to publish findings that show medications in an unfavorable light.
“There’s a long history of adverse action against people who expose drug and chemical harms,” one researcher told Nature.
Another – who said he had been threatened by drug companies in the past – agreed that aggressive tactics are “a very big problem.”
Hundreds of people have recently filed peripheral neuropathy lawsuits against the manufacturers of Avelox, Cipro and Levaquin, the majority of which are pending in a multidistrict litigation now underway in the U.S. District Court, District of Minnesota.
Peripheral neuropathy has been listed as a possible side effect in the prescribing information for Avelox and other fluoroquinolones since 2008. However, the FDA mandated stronger warnings in August 2013, after the agency determined that the labels did not reflect the possible rapid onset of the condition, or the potential for permanence.
Plaintiffs involved in the federal fluoroquinolone litigation accuse the manufacturers of Avelox, Cipro and Levaquin of failing to adequately warn patients and doctors about the drugs’ association with the debilitating nerve disorder, which they assert was known as early as 2001. They further claim that the current label warnings remain inadequate.
Bellwether trials involving Avelox are scheduled to begin in the fall. Verdicts in these early cases could provide some insight into how other juries might decide similar lawsuits involving Avelox and peripheral neuropathy.