Johnson & Johnson’s Janssen Pharmaceuticals unit discontinued production of Levaquin in December 2017, amid growing concerns over the serious side effects and complications potentially associated with the use of fluoroquinolone antibiotics.
The decision affected both oral and injectable versions of Levaquin, as well as another fluoroquinolone called Floxin OTC, which is indicated to treat ear infections.
However, it’s important to note that Janssen has not instituted a Levaquin recall. In fact, all of the affected antibiotic will be available at pharmacies until 2020.
“The decision to discontinue LEVAQUIN was made due to the wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs,” a Janssen spokesperson said in an email to RTV6 in Indianapolis.
In addition to Levaquin, the fluoroquinolone drug class includes:
Fluoroquinolone antibiotics are only indicated to treat serious bacterial infections, such as pneumonia. However, they have been widely overprescribed and their potentially serious side effects have left many to wonder whether the risks associated with fluoroquinolones outweigh their benefits.
Earlier this month, the U.S. Food & Drug Administration (FDA) ordered fluoroquinolone manufacturers to modify their product labels with new information regarding the potential for serious mental health side effects and dangerous low blood sugar levels.
“The new label changes will make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class,” the agency stated in a Drug Safety Communication published on July 10th. “The mental health side effects to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.”
Just two years ago – in May 2016 — the FDA cautioned against the use of systemic fluoroquinolones for most cases of sinusitis, bronchitis, and uncomplicated UTIs. The regulator acted after a review suggested that the antibiotics may cause serious and potentially permanent side effects involving the tendons, muscles, joints, nerves, and central nervous system.
In August 2013, the FDA ordered the drugs’ manufacturers to enhance label warnings regarding their potential to cause a serious and often disabling nerve disorder called peripheral neuropathy.
And in 2008, a black box – the strongest possible safety alert – was added to the labeling of all fluoroquinolone antibiotics to warn of the potential for tendon ruptures and other serious tendon injuries.
In recent years, hundreds of people have filed Levaquin lawsuits, as well legal claims involving Cipro and Avelox, that accuse Janssen and other pharmaceutical companies of concealing the serious risks associated with fluoroquinolone antibiotics. Among other things, plaintiffs contend that they could have avoided peripheral neuropathy and other debilitating injuries had the drugs’ makers provided doctors and patients with adequate warnings regarding these dangers.