Under pressure from advocacy groups, the US Food and Drug Administration has issued an increasingly serious set of warnings about the side effects of the powerful class of antibiotics known as flouroquinolones. Three of the most popular name brands are Levaquin, made by Johnson & Johnson, and Avelox and Cipro, which are both made by Bayer.
A lawsuit recently filed in California federal court against Johnson & Johnson spells out the timeline of various studies raising concerns about this drug, going back to 1992. The lawsuit was filed by a woman who took Levaquin, and developed nerve damage from a condition known as peripheral neuropathy.
The claim notes that in 1992, European scientists wrote to the prestigious British medical journal The Lancet with concerns about a patient who took flouroquinolones (also called “quinolones”) and then developed peripheral neuropathy.
Then in 1996, a review of 37 different reports of nerve damage from quinolones was published.
A U.S. study published in 2001 studied adverse events reported after use of these drugs. Forty-five patients reported long-term nerve damage – most reported cases were serious and lasted longer than one year. That study recommended further investigation into the risk of nerve damage and concluded that if the risk is confirmed, “physicians need to be informed and warnings must be considered for these drugs’ product information.”
In 2003, the FDA reviewed its own adverse events reports from Levaquin and other quinolones and found many cases of peripheral neuropathy.
Later, in 2004 that an amended Levaquin label was approved by the FDA, which stated the risk of nerve damage was rare. The label also suggested that if symptoms occurred, discontinuing use of the drug could “prevent the development of an irreversible condition.”
It wasn’t until August 2013, after pressure from victims and advocates, that the FDA finally agreed that the Levaquin and other quinolone warning labels was not correct. The FDA required manufacturers to remove a statement that nerve damage was “rare” and to add a warning that the onset of nerve damage can be rapid and the condition may be permanent.
In January of 2014, another paper highlighted the fact that there is evidence dating back to 2005 that the use of quinolones can lead to long-term, serious nerve damage.
Most experts acknowledge that in certain serious cases, quinolones are needed and may outweigh the risks, but they are a powerful drug that should be reserved only for cases where other, less powerful drugs aren’t effective. In the California lawsuit, the plaintiff has shown that other drugs, with less serious side effects were available and would have been appropriate to treat her condition. Had the makers properly warned doctors and patients about the risks, the plaintiff likely would have been prescribed a different drug.