In recent years, many more Americans are concerned about what they are putting into their bodies – particularly antibiotics. Much has been published in the mainstream media about potentially serious side effects of these drugs, not to mention widespread fear about the proliferation of antibiotic-resistant microbial strains that are difficult to treat and often fatal.
At the height of their popularity in 2011, more than 23 million fluoroquinolone antibiotic prescriptions were written. Brand names like Cipro, Levaquin and Avelox have landed in the news recently with side effects so serious they’ve warranted a litany of litigation nationwide.
The NY Times reports that Levaquin was the top-selling antibiotic in the United States in 2010, but became the subject of over 2,000 lawsuits one year later.
Those who believe they have suffered harm as the result of fluoroquinolone antibiotic use are encouraged to discuss their case with product liability lawyers at The Sanders Firm, who offer aggressive legal representation for patients harmed by dangerous and defective drugs.
Fluoroquinolones are antibacterial drugs that work by inhibiting two enzymes necessary for DNA replication. The older group includes ciprofloxacin, norfloxacin and ofloxacin. The newer group currently consists of gemifloxacin, levofloxacin, and moxifloxacin.
Merck reports that the following drugs have been withdrawn from the market due to toxicity concerns, including:
- Trovafloxacin – severe hepatic toxicity side effects
- Gatifloxacin- hypoglycemia and hyperglycemia side effects
- Grepafloxacin – cardiac toxicity side effects
- Temafloxacin – acute renal failure, hepatotoxicity, hemolytic anemia, coagulopathy, hypoglycemia side effects
- Lomefloxacin – cardiovascular event side effects
- Sparfloxacin – phototoxicity and central nervous system side effects
- Enoxacin – seizure and central nervous system side effects
The medications are taken orally, metabolized in the liver and excreted in urine or bile. Contraindications exist for patients with previous allergic reactions, predisposition to heart arrhythmias or seizures, and use of drugs that cause bradycardia or QT interval prolongation.
Why do people take fluoroquinolones?
These drugs have been prescribed for a wide range of indications, including:
- Anthrax exposure
- Acute Uncomplicated Cystitis from E Coli or Staph
- Acute Sinusitis
- Bone and joint infections
- Chronic Bacterial Prostatitis
- Complicated Intra-Abdominal Infections
- Infectious diarrhea
- Lower Respiratory Tract Infections
- Skin infections
- Typhoid Fever
- Urinary tract infections
The rate of prescription could be part of the problem, explains the NY Times: “Instead of being reserved for use against serious, perhaps life-threatening bacterial infections like hospital-acquired pneumonia, these antibiotics are frequently prescribed for sinusitis, bronchitis, earaches and other ailments that may resolve on their own or can be treated with less potent drugs or nondrug remedies — or are caused by viruses, which are not susceptible to antibiotics.”
Pharmacological epidemiologist Mahyar Etminan said the drugs are largely prescribed “by lazy doctors who are trying to kill a fly with an automatic weapon.”
Serious fluoroquinolone side effects reported
The most common fluoroquinolone side effects include upper gastrointestinal irritation (in about 5% of patients) and mild central nervous system effects like headaches, drowsiness, dizziness, mood alteration and insomnia (in < 5% of patients). Rarely, patients have reported Clostridium difficile–associated diarrhea and skin rashes.
More serious and debilitating side effects have also come to light, such as:
- Peripheral Neuropathy
- Ventricular arrhythmias and sudden cardiac death
According to an investigation of the FDA database by an ABC News affiliate in Cleveland, there have been at least “3,000 deaths and 200,000 complaints of serious effects associated with Levaquin and similar drugs.” Health care professionals say that the FDA database typically only records 1-10 percent of actual incidents, which would put the number of deaths and injuries much higher.
What happened to people on these antibiotics?
A North Carolina newspaper told the story of 36-year-old Adrienne Myers who took Levaquin for a relatively mild sinus infection. After a couple days, she began experiencing leg pain and blurry vision. Four months later, she was diagnosed with peripheral neuropathy and tendinopathy. She endures grueling physical therapy several times a week to prevent the muscles in her legs from wasting away and struggles with the side effects, which she and her doctor feel are directly related to her use of the fluoroquinolone antibiotic.
The NY Times told the story of 33-year-old Lloyd Balch from Manhattan who began taking Levaquin for a fever, a cough and mild pneumonia. After one dose, he developed widespread pain and weakness. After the second dose, he said the pain in his joints “eviscerated him” and the vision problems were severe. His symptoms ranged from dry skin and mouth, ringing in his ears and delayed urination to numbness and burning in his extremities, heart palpitations and muscle spasms in his back. More than three months after he stopped taking the drug, Mr. Balch still struggles with his symptoms, working with a physical therapist. Experts say it could be a year before he starts to get better – if his symptoms clear up at all.
Bob Paddock told ABC News Channel 5 Cleveland that his wife, Karen, “was forced to use knee pads and a wooden board on rollers to move around” after using Levaquin. “Her wrists hurt her, her ankles hurt her. It was just an accumulation of the various pains from that and other health conditions that pushed her over the edge,” Paddock said, adding that his wife took her own life soon thereafter.
Several studies reveal the dangers inherent in these widely-prescribed antibiotics:
- A 2001 study published in the Annals of Pharmacotherapy found that 71 percent of the fluoroquinolones users with peripheral neuropathy symptoms had trouble with multiple organ systems three months later and 58 percent still struggled a year later.
- A 2012 study published in the Journal of the American Medical Association linked blinding retinal detachment with antibiotic use. Researchers concluded that “patients taking oral fluoroquinolones were at a higher risk [3.3% in antibiotic users vs. 0.6% in controls] of developing a retinal detachment, compared with nonusers, although the absolute risk [4 in 10,000] for this condition was small.”
- A 2013 study published in the Canadian Medical Association Journal found a 2.18-fold increased rate of acute kidney injury among current fluoroquinolone users. The risk was more pronounced in men taking renin–angiotensin-system blockers.
- In 2014, University of Rhode Island researchers looked at the risk of hepatoxicity among fluoroquinolones users and found that “fluoroquinolone use was significantly associated with a 20% increased risk of hepatotoxicity development compared to non-users.” They found the risk was even more significant with ciprofloxacin use, compared to levofloxacin and moxifloxacin.
FDA cautions about fluoroquinolone side effects
The FDA issued a warning in August 2013 that required manufacturers to add peripheral neuropathy as a risk on all labeling. The new black box warning labels stated that nerve damage can occur almost immediately upon taking the drugs — with permanent effects. The link to tendinitis and tendon rupture are also included.
On November 5, 2015, an FDA review panel from the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted overwhelmingly that risks associated with fluoroquinolone antibacterial drugs support a need for a label change.
A large number of patients reported “a constellation of symptoms” known as Fluoroquinolone-Associated Disability (FQAD) – which may include peripheral neuropathy, skin disorders, sensory disturbances, cardiovascular events, neuropsychiatric disorders and musculoskeletal issues. Most patients were previously healthy and took the antibiotics for urinary tract infections, bronchitis or sinusitis – which could have been treated with other types of drugs – and now suffer “a substantial disruption of their normal life functions” with pain, difficulty moving and issues with involuntary functions like breathing, digestion and circulation. After reviewing the panel’s findings, the FDA may choose to release an updated safety communication and/or request a new black box warning on the labels of drugs like Levaquin and Cipro.
Pending litigation in federal courts
There are two federal cases regarding fluoroquinolone drugs pending in the multidistrict litigation in Minnesota, presided over by Justice John R. Tunheim. As of November 2015, there were about 10 cases still pending in MDL 1943 — with all others settled or dismissed.
About 225 lawsuits are still pending in MDL 2642, which includes Levaquin, Avelox and Cipro cases related to irreversible peripheral neuropathy and nerve damage.
Plaintiffs are suing on the following counts:
- Strict Liability – Defendants knew their drugs posed unreasonable risks, but continued to sell the products with inadequate warnings anyway.
- Failure to Warn – Defendants negligently failed to warn patients of known side effects
- Negligence – Defendants breached their duty to properly conduct post-market testing and surveillance to ensure safety
- Fraud – Defendants actively concealed irreversible dangers of their drugs
In November 2012, Bloomberg News reported that Johnson & Johnson agreed to settle about 845 Levaquin cases related to the risks of tendon damage even though the manufacturer had won three of four court cases at trial. In one 2010 loss, J&J was ordered to pay $1.8 million. The terms of the settlement are confidential, so there has been no word as to how much compensation each plaintiff received.
Legal assistance from veteran attorneys
The Sanders Firm is dedicated to helping victims of defective or dangerous products recover maximum compensation for their injuries and financial losses. To learn more about pursuing a Cipro or Levaquin lawsuit, we invite you to call 516-741-5252 (anytime, 24/7) for a free consultation to explore your legal options.
- RX List – Cipro http://www.rxlist.com/cipro-drug/indications-dosage.htm
- Mercola – Flyoroquinolone Antibiotic Side Effects http://articles.mercola.com/sites/articles/archive/2014/11/01/fluoroquinolone-antibiotic-side-effects.aspx
- FDA - Information for Healthcare Professionals: Fluoroquinolone Antimicrobial Drugs http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm
- Merck Manuals – Fluoroquinolones http://www.merckmanuals.com/professional/infectious-diseases/bacteria-and-antibacterial-drugs/fluoroquinolones
- NY Times - Popular Antibiotics May Carry Serious Side Effects http://well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/