Fluoroquinolone Antibiotics Are Linked to Nerve Damage, Heart Attack and Aneurysms
There is strong evidence that patients and doctors have been misled by drug manufacturers about the safety of their powerful and commonly prescribed antibiotic drugs, which have been linked to permanent nerve damage, aneurisms, heart attacks, and other serious health problems. This new evidence has led to a slew of personal injury and wrongful death lawsuits against these drug manufacturers that seemingly placed profit above safety.
Every year doctors prescribe millions of antibiotics to people with common infections as well as more serious conditions. Fluoroquinolone (FLQ) antibiotics are popular and effective and are routinely used to treat infections. Now there is increasing evidence that they are dangerous and can cause life-threatening conditions.
What Are Fluoroquinolone Antibiotics?
Fluoroquinolones are antibiotics that contain fluoride as a central element of the drug. Fluoride is a known neurotoxin, meaning these drugs are able to penetrate into very sensitive body tissues. FLQs are prescribed for a variety of illnesses ranging from infections of the urinary tract to serious respiratory illnesses such as bronchitis and pneumonia.
When they first hit the market these pills were hailed as “wonder drugs.” Millions of people use fluoroquinolones every year and they are the most commonly prescribed class of antibiotics in the United States. In 2010, Bayer's top two antibiotics, Cipro and Avelox, brought in $1 billion in sales.
The giant pharmaceutical company Johnson & Johnson has also been making a fortune out of its FLQ drug. Levaquin made $1.3 billion-worth of sales in 2010. Notwithstanding increasing concerns about these drugs, they have continued to be widely prescribed.
What Are the Potential Side Effects of Fluoroquinolones?
Drugs such as Levaquin, Cipro and Avelox have been linked to a range of conditions from nerve damage to strokes and heart attacks that have claimed the lives of users. Here are the side effects that have alarmed watchdogs and led to a spate of lawsuits:
A number of medical studies and accounts from patients have linked these antibiotic drugs to peripheral neuropathy, a form of permanent nerve damage that causes numbness, pain and weakness, usually to a patient’s hands and feet. It can also affect other areas of the body.
This condition occurs when the walls of the aorta, the main artery of the body, break down, allowing blood to seep into areas of tissue. The condition can lead to serious complications including heart attack, stroke, and paralysis, and even death.
Aneurysms can be deadly because there is little warning to the patient. They often display no symptoms until they suddenly burst causing severe pain and a loss of consciousness. A patient only has a 50 percent chance of survival from a burst aneurysm. Even if you survive an aneurysm, you will require surgery, medications, and a lifetime of costly medical monitoring.
Official Warnings About Fluoroquinolone Antibiotics
In 2003, after it received numerous reports of patients developing symptoms of long-lasting peripheral neuropathy, the U.S Food and Drug Administration (FDA), began investigating the association between FLQs and nerve damage. In September 2004, the FDA required manufacturers of FLQ antibiotics to update their labels to warn about the risks of users developing peripheral neuropathy. The new warning label, which remained in place from 2004 through August 2013, advised patients and doctors that peripheral neuropathy associated with FLQs remained "rare" and could be avoided by discontinuing the drug upon the onset of certain symptoms. Later evidence suggested this was not the case.
In 2013, the FDA warned fluoroquinolone antibiotics should only be used in cases where an infection was believed to be caused by bacteria. The watchdog ordered all makers of FLQ antibiotics to add additional warnings to the product, outlining the risks of peripheral neuropathy. In Aug. 2013 – weeks after the FDA released its warning – the drug makers included warnings about peripheral neuropathy, removing the word “rare” from the new warning about risks.
The FDA warned that fluoroquinolones are associated with an “increased risk of tendinitis and tendon rupture.” This risk is elevated in patients over the age of 60, heart, kidney and lung transplant recipients, and with patients who are also on steroid therapy. At the first sign of tendon pain, inflammation or swelling, patients were advised to stop taking the fluoroquinolone, to stop exercising and to promptly contact their doctor about switching to a non-fluoroquinolone antimicrobial drug.
The FDA notified the makers of FLQs of the requirement to develop and distribute a medication guide to warn patients about the drugs’ side effects.
Although warnings about these dangerous drugs are to be welcomed, they came too late for some patients who have suffered permanent nerve damage. The FDA is yet to warn the public about the potentially more serious conditions of aortic dissection and aneurysm, that are associated with the antibiotics.
In 2015, an FDA advisory panel considered the risks and benefits of FLQs to treat conditions such as acute bacterial bronchitis, acute bacterial sinusitis, and uncomplicated urinary tract infections. The 21-member joint committee backed stronger label warnings on the containers due to the danger of devastating side effects associated with the antibiotics, including permanent neuropathy.
Lawsuits Over FLQs
People who have suffered aortic dissection, aortic aneurysm, or nerve damage have contacted attorneys across the country to file lawsuits against the drug companies, alleging the makers never fairly and adequately warned doctors and patients of these known dangers.
Cases alleging FLQs caused permanent nerve damage are more advanced. More than 2,000 Levaquin cases against Johnson & Johnson were filed in multidistrict legislation in Minnesota. Some of these cases have been settled but about 100 were pending as of 2015.
Lawsuits are currently flooding in against Bayer from patients who say they were harmed by Avelox. The cases that have been filed to date may be the tip of a gigantic iceberg.
These are examples of FLQ antibiotics in litigation:
- Avelox (moxifloxacin hydrochloride)
- Cipro XR (ciprofloxacin)
- Cipro (ciprofloxacin)
- Noroxin (norfloxacin)
- Floxin (ofloxacin)
- Factive (gemifloxacin mesylate)
- Levaquin (levofloxacin)
- Maxaquin (lomefloxacin hydrochloride)
- Zagam (sparfloxacin)
- Proquin XR (ciprofloxacin hydrochloride)
- Raxar (grepafloxacin hydrochloride)
Why the Drug Companies May be to Blame For Fluoroquinolone Antibiotics Side Effects?
The giant drug companies including Bayer and Johnson & Johnson have claimed their products are effective and safe but more people are coming forward to claim these antibiotics have caused them serious damage and the drugs have even been linked to deaths. Medical studies have linked fluoroquinolones to an increased risk of aortic dissection and aortic aneurysm as well as the risk of permanent peripheral neuropathy.
The lawsuits brought against the manufacturers accuse them of dismissing the risk as rare and failing to adequately warn patients and doctors that conditions such as nerve damage could be permanent.
The peripheral neuropathy lawsuits allege the labels on the drugs were misleading to patients and the pharmaceutical companies deliberately used confusing language on the packaging to mask the danger of permanent nerve damage. The lawsuits also say the drug companies knew their products were harmful but continued to market them to an unsuspecting public and to doctors.
The drug companies are accused of negligence in failing to warn of the dire side effects of antibiotics such as Cipro, Avelox and Levaquin and not mentioning aortic dissection and aneurysm in the warnings. The lawsuits claim the drug companies were also negligent in that they failed to conduct proper tests on these drugs before they were marketed and sold. Some of the claims go further and accuse the companies of fraud in actively hiding the risk of the drugs, in particular irreversible peripheral neuropathy.
If you or a family member has been hurt by FLQ antibiotics, our dangerous drugs injury attorneys will provide you with experienced legal representation and ensure your claim is handled correctly among others in the mass tort litigation. We can assist you, no matter where you reside and provide you with individual, personal service to ease you through the claims process. Call us at 757.455.0077 or toll free at 866-455-6657 for a free consultation.