The US Food and Drug Administration issued a December 2018 warning that taking FLQs (fluoroquinolones antibiotics) puts patients at a higher risk of ruptures or tears in the aorta. According to the FDA’s analysis of adverse events, the risk of aortic aneurysm in the general FLQ-using population is nine per 100,000. However, in high risk populations, the risk elevates to 300 per 100,000 people.
Previously, in May 2017, the FDA had said research did not support an association, as the underlying mechanism is not yet understood. Since then, at least four observational studies indicate twice the rate of aortic aneurysm rupture and dissection in those taking fluoroquinolones, so the FDA feels the enhanced guidance is now necessary. The warnings will be added to product labels and prescribing information for physicians, but for those already injured, it is too little, too late.
What Dangers Are Associated with FLQs?
According to the FDA, fluoroquinolones have been linked with an increased risk of:
- Aortic Aneurysm – Aortic aneurysms are abnormal bulges in the wall of the major blood vessel (aorta) carrying blood from the heart to the body. The bulge may occur in the chest, the abdomen, or both. Having an aortic aneurysm increases your risk of aortic rupture and dissection.
- Aortic Dissection – When a tear develops along the inner wall of the aorta, the layers of the wall weaken and separate. Aortic dissection can cause kidney failure, life-threatening intestinal damage, stroke, aortic valve damage (aortic regurgitation), or ruptured heart lining (cardiac tamponade). The condition is fatal when blood rushes outside the aortic wall, causing uncontrolled internal bleeding.
In addition to these potentially fatal complications, the FDA has previously warned of other adverse side effects:
- 2008 – The FDA added a Boxed Warning that fluoroquinolones increase the risk of tendinitis and tendon rupture.
- 2013 – A label update warns that fluoroquinolones taken orally or by injection can cause peripheral neuropathy.
- 2016 – A revised Boxed Warning suggests potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system, and that patients should only use the drugs if no other options exist.
- 2018 – The FDA announced a label update to strengthen warnings about the risk of mental health effects including delirium, memory impairment, and disorientation. They also added the potential risk of hypoglycemic coma.
Are You at Risk for Antibiotic Related Heart Damage?
Antibiotics commonly prescribed for upper respiratory infections and urinary tract infections can cause potentially fatal harm to the heart. The fluoroquinolones class of antibiotics (FLQs) include:
- Avelox (moxifloxacin)
- Cipro (ciprofloxacin)
- Factive (gemifloxacin)
- Floxin (ofloxacin)
- Levaquin (levofloxacin)
- Moxifloxacin (Avelox)
Patients should call 9-1-1 or go to the emergency room immediately if they are taking one of these antibiotics and encounter sudden, severe, constant pain in the stomach, chest, or back. The pain is often described as a “tearing, ripping, or shearing” sensation that radiates to the neck or back. Accompanying side effects often include sweating, dizziness, shortness of breath, nausea, and vomiting. You may have stroke-like symptoms with sudden difficulty speaking, loss of vision, and weakness or leg paralysis on one side.
When used appropriately, antibiotics can save lives. However, patients with certain conditions should not take this type of antibiotic:
- The elderly
- High blood pressure
- Peripheral vascular disease
- Past history of aorta or other blood vessel blockages or aneurysms
- Genetic disorders affecting blood vessels (such as Marfan, Turner’s, Loeys-Dietz, and Ehlers-Danlos syndromes)
An ultrasound of the heart and aorta done by a cardiologist is a simple, noninvasive screening tool to prevent the increased risk of aortic aneurysm or dissection. However, until recently, doctors were not given adequate instructions on how to screen patients for FLQ use.
Contact Showard Law Firm to Explore Your Legal Options
Aortic aneurysms and aortic dissections are serious health conditions. The manufacturers of these drugs should have known of the risks associated with their antibiotics and warned patients before releasing them to market. Showard Law Firm offers free, no-obligation consultations to patients who want to know if they have a valid claim for compensation. There are no upfront charges to our representation, should you decide to file a civil lawsuit.
If successful, you may win substantial compensation for past, present, and future medical bills; lost wages and loss of future income; as well as emotional pain and suffering. Surviving family members of deceased loved ones can obtain money for wrongful death, infliction of emotional distress, funeral expenses, and burial costs. The statute of limitations deadline to file a lawsuit varies by state, but could be as short as two years, so contact one of our experienced attorneys right away.
- The Cardiology Advisor – Fluoroquinolones Linked With Aortic Dissections & Aneurysms, https://www.thecardiologyadvisor.com/home/topics/vascular-medicine/fda-fluoroquinolones-linked-with-aortic-dissections-aneurysms/
- Mayo Clinic – Aortic Aneurysm, https://www.mayoclinic.org/diseases-conditions/aortic-aneurysm/symptoms-causes/syc-20369472
- NBC News – FDA Warns Some Antibiotics Can Cause Serious Heart Damage, https://www.nbcnews.com/health/health-news/fda-warns-some-antibiotics-can-cause-serious-heart-damage-n950606
- PulmCCM – FDA Warns of Aortic Dissection With Fluoroquinolones, https://pulmccm.org/infectious-disease-sepsis-review/fda-warns-of-aortic-dissection-with-fluoroquinolones/
- Center for Infectious Disease Research and Policy – FDA Says Fluoroquinolones May Cause Aortic Rupture in Some, http://www.cidrap.umn.edu/news-perspective/2018/12/fda-fluoroquinolones-may-cause-aortic-rupture-some