The European Medicines Agency (EMA) has endorsed tough restrictions on fluoroquinolone antibiotics, amid concerns that the drugs can cause nerve damage, tendon ruptures, and other potentially permanent side effects.
The move comes as hundreds of plaintiffs continue to pursue personal injury lawsuits against the manufacturers of Levaquin, Cipro, and Avelox in courts throughout the United States.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the restrictions last month, once it concluded a review of systemic fluoroquinolone antibiotics that began in 2017.
The EMA Committee for Human Medicinal Products (CHMP) endorsed the PRAC recommendations on November 16th. They now move to the European Commission, which will issue a legally-binding opinion.
At that point, the prescribing information for systemic fluoroquinolones marketed in the European Union will be updated with new safety information, including a statement advising patients to stop treatment at the first sign of any problem that affects their muscles, tendons, joints, or the nervous system.
The restrictions mean systemic fluoroquinolone antibiotics should not be prescribed:
Additionally, they should be used with caution in the elderly, those with kidney disease, or patients who have undergone organ transplants, as these individuals are more likely to suffer a tendon injury.
Finally, doctors should avoid prescribing fluoroquinolone antibiotics in conjunction with corticosteroids, as doing so may also increase the risk of tendon damage.
Systemic fluoroquinolones include oral, injectable, and inhaled versions of Levaquin, Cipro, and Avelox, as well as various generic formulations.
Over the past several years, the U.S. Food & Drug Administration (FDA) has also issued a series of warning regarding the potentially debilitating side effects associated with these drugs, including peripheral neuropathy, tendon injuries, and most recently, severe blood sugar disturbances and mental health problems.
In May 2016, the FDA warned doctors not to prescribed systemic fluoroquinolones to treat most cases of sinusitis, bronchitis, and uncomplicated urinary tract infections when other treatment options are available. The agency acted after a review tied the drugs to potentially permanent side effects involving the tendons, muscles, joints, nerves, and central nervous system.
Hundreds people in the Uniteds States have filed lawsuits for injuries they claim were caused by Levaquin, Cipro, or Avelox. By 2015, for example, Johnson & Johnson and its Janssen Pharmaceuticals unit had agreed to settle thousands of Levaquin tendon damage lawsuits.
Hundreds of peripheral neuropathy lawsuits involving Levaquin, Cipro, and Avelox are currently moving forward in courts throughout the United States.
Several Levaquin lawsuits have also been filed on behalf of individuals who allegedly experienced life-threatening aortic injuries while using the antibiotic.