New FDA Warning About Fluoroquinolone Antibiotics –
When IC patient Naomi* was prescribed Cipro for a bladder infection several years ago, she had no idea that it would lead to a life threatening aortic aneurysm. She, and others, found both both answers and outrage in an FDA safety alert released in May which required a stronger black box warning for fluoroquinolone medications (aka Levaquin, Cipro and Avelox) and urged that it only be used when no other therapy is available.(1)
Naomi shared “We’ve spent years trying to figure out why this happened to me. I had no risk factors, no family connection with aneurysms. But I did take Cipro several times including one months long prescription. It was often prescribed by my physicians.”
Introduced in 1987, Cipro is a fluroquinolone antibiotic used to treat a wide variety of infections, including UTI and chronic prostatitis, some skin infections, respiratory tract, ear and joint infections. But it has a long record of serious side effects.
In 2008, the FDA issued a Black Box warning about an increased risk of tendinitis and tendon rupture, especially in the elderly. In 2013, the FDA warned about possible seizures and irreversible peripheral neuropathy. Headache, dizziness, and insomnia, tremor, anxiety, hallucination and suicide attempts were also reported.
In the latest alert (May 12, 2016), the FDA explained “a safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.”(2) They concluded that the risk of serious side effects outweigh the potential benefits for patients with acute sinusitis, bronchitis and uncomplicated UTI.
Aortic aneurysm, however, seems to be an unusual type of complication. It was first discovered in 2015 when researchers shared a study showing a roughly two fold increased risk for aortic aneurysm and aortic dissection within 60 days of Cipro use. The connection appears to be collagen, which is found not only in tendons but also in the aortic wall. The researchers wrote “As fluoroquinolones may induce degradation of collagen causing tendinopathy, this raises the concern that fluoroquinolones may cause or aggravate aortic aneurysm and dissection by a similar mechanism.”(3)
Naomi said that her symptoms were, at first, quite subtle and generic. She experienced shortness of breath and difficulty climbing up stairs without resting. A fit and energetic woman 51 year old, she sought answers from her primary care doctor. It took several visits and a referral to a cardiac center before she was diagnosed correctly.
If you are currently using Cipro or any other fluoroquinolone medication and show any signs and symptoms of serious side effects (currently or previously) including tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations, you should contact your physician immediately. You should also talk with your doctor about the other antibiotic options available.
The FDA further urged all health care professionals to stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.
As to Naomi, they are carefully monitoring the progress of her aortic aneurysm which is, thankfully, growing at a small rate. She knows, however, that she could face open heart surgery to correct it. She urges every patient to discuss with their physician the use of other antibiotic medications that don’t carry these life threatening risks.
*Name has been changed
References:
1. FDA announces safety labeling changes for fluoroquinoloes. May 12, 2016 –
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm500325.htm
2. FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. Ma 12, 2016 – http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm
3. Boyles S. Fluoroquinolones May Increase Aortic Aneurysm Risk. Medpage Today. Oct 19, 2015 – http://www.medpagetoday.com/cardiology/prevention/53950
