The FDA Issues Antibiotics Injuries Warnings | Pharmaceutical Lawyer
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The FDA Issues New Warnings for Common Antibiotics

Drug injury lawyer and product liability attorney reviewing antibiotics Injuries for injured plaintiffs nationwide


The U.S. Food and Drug Administration (FDA) recently released new warnings on the “disabling” side effects and antibiotics injuries from commonly used fluoroquinolones. The agency says the drugs can be dangerous and their use should be restricted.

The FDA’s warnings, placed on the drugs’ labels and warning inserts, aim to inform patients that the serious side effects and antibiotics injuries of these medications generally outweigh the benefits, particularly if patients have other treatment options. The most severe side effects can involve damage to tendons, muscles, joints, nerves and the central nervous system.

Some of the most dangerous of the antibiotics have already been removed from the market because of their side effects, but the FDA has stopped short of a complete ban on some popular drugs.

This class of drugs include large brand names include Bayer AG’s Cipro (ciprofloxacin) and Johnson & Johnson’s Levaquin (levofloxacin).

Joe Lyon is a highly-rated Cincinnati pharmaceutical liability attorney, representing plaintiffs nationwide in a wide variety of wrongful death and injury claims related to dangerous pharmaceutical products.  


Fluoroquinolones & Antibiotics Injuries

The FDA’s recent action follows a study by its Office of Surveillance and Epidemiology, which found “an association between fluoroquinolone antibiotic use and disabling peripheral neuropathy.”

In 2013, the FDA issued a warning about permanent nerve damage as a possible side effect of fluoroquinolones, such as Cipro and others. The agency said the damage “may occur rapidly,” and could be “potentially permanent.”
In the FDA Adverse Event Reporting database, there are over 1,000 reports of nerve damage after fluoroquinolone use, and only 10 percent reported improvement or recovery. In some cases, disability was so severe that continued employment was not possible.


FDA Warns of Tendon Damage

As far back as 2008 the FDA knew about major concerns and risks for this class of antibiotics. That year they added the “black box” warning to seven fluoroquinolone drug labels and prescribing information, primarily because of the added risk of tendon rupture. The drugs named in the warning included:

•    Ciprofloxacin
•    Gemifloxacin
•    Levofloxacin
•    Moxifloxacin
•    Norfloxacin
•    Ofloxacin


By 2008, there had been over 400 reports of tendon rupture and about 340 cases of tendinitis in patients using fluoroquinolone antibiotics. At the time, the agency recommended that patients be switched to alternative treatments before tendons ruptured.


Symptoms of Possible Tendon Damage

Pain, swelling, inflammation, and tears of tendons are common in patients taking fluoroquinolone antibiotics. The Achilles tendon, at the back of the ankle, is a very commonly affected area.

Signs or symptoms of tendon rupture include:

•    A snap or pop in a tendon area
•    Bruising right after an injury in a tendon area
•    Inability to move an affected area
•    Inability to bear weight


Risk of Antibiotics Injuries

Anyone who takes fluoroquinolones like Cipro and Levaquin could be at risk. Evidence suggests the duration of drug therapy is not a factor; antibiotics injuries and side effects can begin even after the first dose.

Some reports describe young, healthy patients who take a fluoroquinolone and days later is unable to run or even walk without support. The FDA has said the risk of tendinitis and tendon rupture is even higher in people with the following factors:

•    Over 60 years of age
•    Taking steroids (corticosteroids)
•    Kidney, heart, or lung transplant recipient
•    History of tendon problems in the past (including rheumatoid arthritis)


Other Risks of Antibiotic Use

The recent FDA review focused on the risks of nerve damage and tendon rupture with the use of antibiotics. However, patients may develop other serious adverse effects, including:

•    Convulsions
•    Hypersensitivity
•    Hallucinations
•    Depression
•    Vision problems
•    Cardiac issues
•    Fatigue
•    Muscle aches
•    Joint pain
•    Anxiety


Overprescribed Antibiotics

Fluoroquinolones like Cipro and Levaquin are very commonly prescribed. Data supplied by IMS Health, the drug-research firm, said there were a total of more than 36 million prescriptions written in 2014. The Centers for Disease Control and Prevention (CDC) claims that 50 percent of these prescriptions may be “inappropriate.”

Patients are regularly prescribed fluoroquinolones for sinusitis, bronchitis or uncomplicated urinary tract infections, even though there are other safer options available.

The class of antibiotic have become so popular in part because they resolve infections quickly, but that could be a shortsighted decision seeing as they come with more side effects and antibiotics injuries than other drug options.


Common Antibiotics Cause Injury

•    Avelox
•    Cipro
•    Ciprofloxacin
•    Noroxin
•    Factive
•    Norfloxacin
•    Gemifloxacin
•    Floxin
•    Proquin
•    Levaquin
•    Levofloxacin
•    Moxifloxacin
•    Ofloxacin


The FDA’s reporting database of complaints involving Cipro and Levaquin alone show almost 200,000 adverse reactions from 1997 to 2015. This could be a great underestimate of the issue, because only a small fraction of patients who experience side effects report them.


If you or a loved one suffered an aortic dissection or medication-related injury after taking Fluoroquinolones , and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding antibiotics injuries.

Contact us today.