FDA Issues New Warning on Fluoroquinolone Antibiotics and Aortic Aneurysm
On December 20, 2018, the U.S. Food and Drug Administration (FDA) issued a new safety announcement informing health care professionals to avoid prescribing fluoroquinolone antibiotics to patients who have aortic aneurysms or are at risk for an aortic aneurysm. This includes patients with hypertension, peripheral atherosclerotic, vascular diseases, Marfan syndrome, Ehlers syndrome, Danlos syndrome, and elderly patients.
The FDA review found that fluoroquinolone antibiotics can increase the occurrence of ruptures or tears in the aorta, the main artery in the body. These tears are called aortic dissections can lead to dangerous bleeding or death.
The FDA warned that fluoroquinolone medicines should not be used in patients with increased risk unless no other treatment options are available. People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.
The FDA is also requiring new warnings be added to the prescribing information and patient medication guide for all fluoroquinolones. The FDA warning is based on cases reported to the FDA and observational studies that have provided consistent evidence that fluoroquinolones are associated with an aortic aneurysm or aortic dissections.
ABC News report on fluoroquinolone dangers:
Who Should Join the Fluoroquinolone Antibiotics Aortic Aneurysm Lawsuit?
First Legal Requirement: To join the fluoroquinolone antibiotics aortic aneurysm lawsuit, the victim must have taken one of the medicines listed in the next section below.
Second Legal Requirement: To join the fluoroquinolone antibiotics aortic aneurysm lawsuit, the victim must have been diagnosed with aortic aneurysm or aortic dissection within one year of last use.
Medicines Covered in the Fluoroquinolone Antibiotics Aortic Aneurysm Lawsuit
Avelox (moxifloxacin) was first patented in the United States. Avelox was approved by the FDA to treat bacterial infections of the skin, sinuses, lungs, and stomach and other bacterial infections.
Baxdela (delafloxacin) is used for the treatment of acute bacterial skin and skin structure infections in adults.
Cipro (ciprofloxacin) is used to treat bacterial infections in many different parts of the body. Cipro (ciprofloxacin) tablets and oral liquid are also used to treat anthrax infection after inhalational exposure. Cipro (ciprofloxacin) is also used to treat pneumonic plague and septicemic plague.
Factive (gemifloxacin) is used to treat bronchitis and pneumonia caused by bacterial infections.
Floxin (ofloxacin) is a broad-spectrum fluoroquinolone antibiotic used to treat bacterial infections that cause bronchitis, urinary tract infections, pneumonia, chlamydia, gonorrhea, skin infections, and prostate infections. Floxin (ofloxacin) is also commonly used to treat outer ear infections (swimmer’s ear) and middle ear infections by stopping the bacteria growth.
Levaquin (levofloxacin) is used to treat community-acquired pneumonia, acute bacterial sinusitis, complicated urinary tract infections (UTI), and acute pyelonephritis.
Maxaquin® (lomefloxacin HCl)
Maxaquin antibiotics are used to treat mild to moderate infections of designated organisms in the lower respiratory tract and urinary tract.
Noroxin (norofloxacin) is used in the treatment of prostatitis caused by E. coli, urinary tract infections (UTI), gonorrhea, and traveler’s diarrhea.
Proquin XR® (Ciprofloxacin)
Proquin XR® is a widely used antibacterial medicine. Proquin XR is used to treat a wide array of various bacterial infections throughout the body.
Raxar is an antibiotic medicine used to treat chronic bronchitis, strep, urethritis, cervicitis, and chlamydia.
Zagam is a broad spectrum antimicrobial medicine generally used for acute bacterial exacerbations of chronic bronchitis caused by Chlamydia pneumoniae, Enterobacter, cloacae, Haemophilus influenzae, and strep.
Fluoroquinolone Antibiotics’ Long History of FDA Warnings
The FDA warning about increased risk of ruptures or tears in the aortic blood vessel from fluoroquinolone antibiotics is not the first warning issued. Fluoroquinolone antibiotics such as Avelox, Cipro, and Levaquin, regularly introduce new warnings. The fluoroquinolone antibiotics aortic aneurysm lawsuit is not the first round of lawsuits to be filed against these drug makers for new side effects.
- July 2008: The FDA first added a warning to fluoroquinolones for the increased risk of tendinitis and tendon rupture. There were 341 reported cases before the FDA issued a black box warning.
- February 2011: The FDA issued fluoroquinolones warnings regarding the risk of worsening symptoms for those with myasthenia gravis.
- August 2013: The FDA required updates to the label to describe the potential for irreversible serious nerve damages, like peripheral neuropathy.
- November 2015: The FDA advisory committee concluded that the serious risk associated with fluoroquinolones for types of uncomplicated infections generally outweigh the benefits for patients with other treatment options.
- May 2016: The FDA drug safety committee advised that fluoroquinolones should be reserved for conditions only when there are no other options available due to potential permanent disabling side effects.
- July 2016: The FDA approved label changes for fluoroquinolones warnings that covered disabling and potentially permanent side effects. The FDA warned doctors to limit their use in patients with less serious bacterial infections. The FDA warnings cover disabling side effects involving tendons, muscles, joints, nerves, and the central nervous system. These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.
Aortic Aneurysm Risks From Fluoroquinolone Antibiotics
The aorta is a large artery that carries blood from the heart through the chest and torso. An aortic aneurysm is a balloon-like bulge in the aorta. The force of blood pumping can split the layers of the artery wall, allowing blood to leak between them. This process is called an aortic dissection. The aortic aneurysm can bust completely, causing bleeding inside the body – this is called an aortic rupture.
There are two types of aortic aneurysms:
- Sharp sudden pain in the chest or upper back
- Shortness of breath
- Trouble breathing or swallowing
- Occurs below the chest
- More common than thoracic aortic aneurysms
- Abdominal aortic aneurysms often do not have any symptoms
High-Risk Patients Fluoroquinolone Complications
- People at increased risk include those with a history of blockages or aneurysms of the aorta or other blood vessels
- High blood pressure
- Certain genetic disorders that involve blood vessel changes
- Elderly patients
FAQ: Fluoroquinolone Antibiotics Aortic Aneurysm Lawsuit
What are fluoroquinolones antibiotic medicines used for?
Fluoroquinolones antibacterial drugs were first approved by the Food and Drug Administration (FDA) in 1978 to help treat a variety of diseases caused by bacteria. Fluoroquinolones are a type of quinolone antibiotic commonly used to treat lower respiratory tract infections, skin infections, urinary tract infections, inflammation of the prostate, sinusitis, gonorrhea and other diseases caused by bacteria.
Are fluoroquinolone antibiotic medicines safe?
Generally, yes. However, the risks are severe. Fluoroquinolone antibiotic drugs are very effective in killing certain types of bacteria in certain locations in the body. Avelox, Cipro, Levaquin, and the rest of the fluoroquinolone antibiotics are widely prescribed and usually cause no side effects. Never stop taking your fluoroquinolone antibiotic medication without first consulting your doctor.
Why were fluoroquinolones approved by the FDA with serious side effects?
Unfortunately, the FDA approves defective and potentially dangerous medicines all the time. Consumers often do not know of all the risks until the product has been used for long periods of time. Drug manufacturers regularly update their warning labels as dangerous new side effects appear. Drug injury class action lawsuits, such as the fluoroquinolone antibiotics aortic aneurysm lawsuit, generally occur after the warning label has been updated. Many times lawsuits against drug manufacturers happen after the FDA issues a warning or pulls the product from the market.
Can I afford a fluoroquinolone antibiotics aortic aneurysm lawsuit attorney?
Yes. You will only pay your fluoroquinolone antibiotics aortic aneurysm lawsuit lawyer if they win your case. If your case is unsuccessful, your fluoroquinolone antibiotics aortic aneurysm lawsuit attorney gets paid nothing. Your fluoroquinolone antibiotics aortic aneurysm lawsuit attorney will never ask for any compensation upfront for legal services.
How do I find out if I should join the fluoroquinolone antibiotics aortic aneurysm lawsuit?
Reach out to Woods & Woods to find out if you should join the fluoroquinolone antibiotics aortic aneurysm lawsuit. We can have a chat about your case and determine whether you should pursue a case against the fluoroquinolone antibiotic drug manufacturers. There is never a fee to talk with a fluoroquinolone antibiotics aortic aneurysm lawsuit attorney.
Get Help From a Fluoroquinolone Antibiotics Aortic Aneurysm Lawsuit Attorney
Since 1985, the drug injury lawyers at Woods & Woods have assisted thousands of people nationwide. Our law firm is proud to partner with several of the leading plaintiffs’ law firms around the country. Together, we use our strengths to fight for those injured by defective and dangerous medicines.
If you were injured, let’s have a conversation about the fluoroquinolone antibiotics aortic aneurysm lawsuit. We’ll give you an honest opinion and determine what steps you should take next if joining the fluoroquinolone antibiotics aortic aneurysm lawsuit.