European regulators have recommended new restrictions for systemic fluoroquinolones, a class of antibiotics that has also drawn scrutiny – both legal and regulatory – in the United States.
Systemic fluoroquinolones include oral, injectable, and inhaled versions of Levaquin, Cipro, and Avelox, as well as various generic formulations.
These medications rank among the most commonly used – and perhaps most overused – antibiotics in the world, and are prescribed to treat a wide range of bacterial infections, including pneumonia and certain sexually transmitted diseases.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) launched its fluoroquinolone review in February 2017, following a request from Germany’s health authority.
The Committee issued new fluoroquinolone recommendations on Friday, October 5th, citing the drugs’ potential to “cause long-lasting and disabling side effects, mainly involving muscles, tendons, and bones, and the nervous system.”
The PRAC is now warning against the use of systemic fluoroquinolones:
The PRAC also warned that fluoroquinolone antibiotics can increase the risk for tendon injuries, especially among elderly patients, those with kidney issues, those who have undergone an organ transplant, or those who are being treated with corticosteroids. The drugs should be used with extreme caution in these patient populations.
Finally, the Committee advised healthcare providers to warn patients that they should stop taking their fluoroquinolone antibiotic at the first sign of any side effects involving muscles, tendon, bones, or the nervous systems, including:
In recent years, the U.S. Food & Drug Administration (FDA) has issued a series of safety alerts regarding dangerous side effects and complications associated with systemic fluoroquinolones.
Most recently, the agency warned that the drugs had been linked to serious mental health side effects, as well as severe blood sugar disturbances. The labels for all systemic fluoroquinolones, including Levaquin, Cipro, and Avelox, were updated to more prominently list the following mental health problems:
The labels’ “Blood Glucose Disturbances” subsection was also modified to explicitly reflect a potential risk of coma with hypoglycemia.
In 2008, the FDA ordered that a Black Box Warning – its strongest possible safety alert – be added to the labels for all systemic fluoroquinolones to warn of a possible link to serious tendon injuries and ruptures.
The Black Box was updated in 2016 with information regarding potentially permanent side effects involving the tendons, muscles, joints, nerves, and central nervous system. The updated warning also cautioned against using systemic fluoroquinolones to treat most cases of sinusitis, bronchitis, and uncomplicated UTIs when other treatment options are available.
In 2013, the FDA ordered fluoroquinolone manufacturers to enhance label warnings regarding their potential to cause a serious and potentially permanent nerve disorder called peripheral neuropathy.
The continued concerns over fluoroquinolone side effects have also encouraged numerous plaintiffs to file antibiotics lawsuits against the manufacturers of Levaquin, Cipro, and Avelox.
In 2012, for example, Bloomberg reported that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary had settled hundreds of Levaquin tendon injury lawsuits
Peripheral neuropathy lawsuits involving Levaquin, Cipro, and Avelox are currently undergoing coordinated pretrial proceedings in the U.S. District Court, District of Minnesota. (MDL No. 15-MD-2642)
Several Levaquin lawsuits have also been filed on behalf of individuals who allegedly experienced life-threatening aortic injuries due to their treatment with the medication. These claims followed the publication of several studies that suggested fluoroquinolones were associated with an increased risk of aortic dissection and aortic aneurysm.
Janssen ceased production of both oral and injectable versions of Levaquin in December 2017.
The company did not, however, issue a Levaquin recall, and indicated that its decision reflected “the wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs.”
As such, Levaquin will remain available at pharmacies until 2020.