SILVER SPRING, Md. — A United States Food and Drug Administration panel has concluded that fluoroquinolone antibiotics require stricter health warnings for the serious side effects that have become associated with them. The panel was convened in early November of last year in order to address the mounting reports of injuries from the drugs. The FDA already issued a health warning for fluoroquinolones back in 2013 and began requiring fluoroquinolone manufacturers to include a warning on the drugs’ containers acknowledging the risk of patients developing peripheral neuropathy, tendinitis and tendon rupture as a result of taking the drugs. Although this latest panel was overwhelmingly in favor of modifying the health warning for fluoroquinolones, the FDA is not required to follow their recommendation.
Side Effects of Fluoroquinolones
Fluoroquinolones are a class of antibiotic medications that are typically prescribed to treat bronchitis and infections such as sinus infections and urinary tract infections. Some popular fluoroquinolone products include ciprofloxacin, gemifloxacin, levofloxacin and ofloxacin. In recent years, they have become linked with the development of nerve damage in the patients who have been prescribed them, including the kinds of nerve damage warned about by the FDA above. Often, this nerve damage can be irreversible. A recent study published in JAMA Internal Medicine has also linked the popular class of drugs with potentially deadly cardiac complications including aortic aneurysms and aortic dissection.
Proposed Changes to Warning Labels
As more and more studies are published about the risks of fluoroquinolones and as more reports of side effects are submitted to the FDA, it becomes more and more likely that the warning labels for fluoroquinolones will be modified. The increasing number of lawsuits against fluoroquinolone manufacturers may have also been a factor in the panel meeting as well as its conclusion that the drugs’ risks need to be more widely known. There are currently several lawsuits pending against fluoroquinolone product manufacturers including Bayer HealthCare Pharmaceuticals, Janssen Pharmaceuticals, Inc., Johnson & Johnson, Inc., Merck & Company, Inc. and Schering Corp. The lawsuits allege that the plaintiffs were injured as a result of taking fluoroquinolone products and that the manufacturers knew or should have known about the serious risks that were linked to these products but failed to notify the plaintiffs.
The November panel has recommended that the updated warning continue to warn of the risk of patients developing tendinitis, tendon rupture and peripheral neuropathy but that the warning contain stronger wording and be easier to read.
Our Fluoroquinolone Lawyers Can Help You
Our Fluoroquinolone attorneys can help if you or someone you care about was harmed by Fluoroquinolone. Lawsuits have been filed against the drug maker by both patients and their families seeking compensation for injuries caused by these dangerous drugs. You may be entitled to a settlement. We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it in all in writing for you. Our Fluoroquinolone lawyers will help you file your lawsuit.
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