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A new report reveals that Johnson & Johnson’s Janssen Pharmaceuticals subsidiary quietly ceased production of Levaquin late last year, ahead of new label warnings recently required by federal regulators about potential mental health side effects linked to the controversial antibiotic.
In what was effectively a silent Levaquin recall, RTV6 in Indiana reports that the drug maker discontinued production of both the oral and IV name-brand versions of Levaquin in December 2017, without any apparent public announcement about the decision.
Janssen also ceased production on Floxin Otic ear drops, which belongs to the same class of antibiotics as Levaquin, known as fluoroquinolones.
The revelation comes just days after the FDA issued a drug safety communication warning new fluoroquinolone warnings, which would require Levaquin, as well as Avelox, Cipro and other members of the class, to carry new label information that indicates they may cause mental health problems, as well as significant decreases in blood sugar. Those warnings were the latest in a string of serious health risks linked to the antibiotics.
Janssen officials who spoke to RTV6 reporters said that the discontinuation was due to the availability of other alternatives for patients and a company focus on developing unmet patient needs.
According to the FDA, doctors should stop treatment with Levaquin, Avelox and similar drugs immediately if patients report experiencing central nervous system side effects, psychiatric adverse reactions, or blood glucose problems. They should switch those patients to a non-fluoroquinolone antibiotic if possible.
The agency also warned doctors to make their patients aware of the risks of low blood sugar when taking these drugs, and that psychiatric adverse reactions could occur after just one dose.
The FDA recommends that health care professionals be aware of the new warnings and the potential risk of hypoglycemia that can result in coma, which could occur more frequently in elderly patients or diabetics taking insulin or an oral hypoglycemic medication.
Fluoroquinolone Side Effects
Hundreds of Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits have been filed in recent years, each raising similar allegations that the drug makers failed to adequately investigate the safety of their drugs or warn about the disabling side effects. Plaintiffs maintain that they may have avoided long-term and permanent peripheral neuropathy problems if adequate warnings had been provided.
The widely used class of antibiotics has been on the market since the 1980s, including brand names like Levaquin, Cipro, Avelox, Factive, Baxdela, and more than 60 generic equivalents. The new warnings apply to those fluoroquinolones taken by mouth or by injection, and is the latest in a string of label updates required in recent years.
In August 2013, the FDA required the makers of all fluoroquinolones to provide stronger warnings about the peripheral neuropathy risk from the antibiotics, indicating nerve problems associated with the drugs may last for months or years after an individual stops taking the drug.
The FDA issued a major fluoroquinolone antibiotics warning in May 2016, due to a variety of “disabling and potentially serious side effects,” which led the agency to conclude that the risks may outweigh the benefits associated with using the medications to treat uncomplicated infections.
That warning concerned reports of permanent nerve damage, known as peripheral neuropathy, as well as tendon ruptures and other health risks.
Concerns about the risk of aortic dissection and aortic aneurysm with fluoroquinolones emerged in late 2015, following the publication of a report in the medical journal JAMA Internal Medicine, which found that current use of Levaquin, Avelox or other similar antibiotics was associated with a two-fold increased risk of suffering an aortic aneurysm or dissection injury.