Levaquin Pulled from Market to Avoid FDA Action
By Emily Cox
A new report indicates that, rather than risk stigmatizing its brand with mental health risks or issue a proper recall, Johnson & Johnson’s Janssen Pharmaceuticals unit quietly stopped marketing Levaquin late last year as concerns over mental health risks associated with the controversial antibiotic began reaching a fever pitch.
According to RTV6 in Indiana, the drug manufacturer simply halted production of both the oral and IV versions of Levaquin in December 2017 without any public announcement pertaining to the decision. The defective product just simply ceased to be available in what was effectively a silent recall.
Janssen also discontinued Floxin Otic ear drops production. The ear drops belong to the same class of antibiotics as Levaquin – fluoroquinolones.
FDA Issues Levaquin Safety Communication
The news report comes on the heel of the FDA issuing a drug safety communication regarding new fluoroquinolone warnings days earlier. The agency will require Levaquin, Avelox, Cipro, and other members of the class to include significant new warning label information that indicates the drugs can cause mental health problems along with significant decreases in blood sugar. These warnings are the latest in a string of serious health risks from the antibiotic class.
Janssen officials told RTV6 reporters that the company discontinued Levaquin due to the availability of alternatives and a firm resolve to focus on developing treatments that address unmet patient needs.
The FDA’s announcement indicated that doctors need to stop treatment with Levaquin, Avelox, and other fluoroquinolones immediately if patients report central nervous system side effects, psychiatric adverse reactions, or blood glucose problems. If possible, the agency encouraged physicians to switch patients to non-fluoroquinolone antibiotics.
The agency also warned about the imperative nature of these side effects and that doctors need to make their patients aware of the risks of low blood sugar while taking these drugs and that psychiatric adverse reactions could start occurring after as little as one dose of the powerful antibiotics.
The FDA recommends healthcare professions take special heed of the new warnings and the hypoglycemia risk that can result in patients falling into a coma, especially elderly patients and diabetics taking insulin or an oral hypoglycemic medication as these patients are more prone to these damaging side effects.
Levaquin Side Effects and Lawsuits
Hundreds of individuals have filed lawsuits over debilitating injuries from Levaquin, Avelox, Cipro, and other fluoroquinolones, alleging that manufacturers deliberately failed to warn patients about the disabling side effects. Plaintiffs assert that they could have avoided long-term and permanent peripheral neuropathy damage if the drug makers had provided adequate warnings to ensure patient safety.
The exceptionally popular class of antibiotics hit the market in the 1980s. They include brand names such as Levaquin, Cipro, Avelox, Factive, Baxdela, as well as more than 60 generic equivalents. The new warnings are the latest in a long line of recent label updates and apply specifically to oral and injectable fluoroquinolones.
In August 2013, the FDA intervened to force fluoroquinolone manufacturers to institute stronger warnings about the antibiotics’ peripheral neuropathy risks. The agency indicated that these nerve problems could last for months or years after antibiotic use is discontinued.
In May 2016, the FDA released a major fluoroquinolones antibiotic warning due to numerous “disabling and potentially serious side effects,” leading the agency to conclude that the risks may outweigh the benefits of using the medications to treat most infections.
This warning came following escalating reports of permanent nerve damage, as well as tendon ruptures and other significant health risks.
Cocerns over aortic dissection and aortic aneurysm risks from fluoroquinolones emerged in late 2015 after JAMA Internal Medicine published a landmark study that found that the use of Levaquin, Avelox and other drugs in the antibiotic class carried a two-fold risk of aortic aneurysm and dissection injuries.