A recent study has found that the antibiotic Factive can double the risk of peripheral neuropathy, a type of nerve damage. Other studies have found higher rates of aortic aneurysm, which is a bulge in the aorta that can rupture and cause internal bleeding.
UPDATE: FDA Strengthens Warnings on Factive
July 26, 2016 — The FDA has updated labels on Factive to warn that the risk of disabling side effects outweighs its benefit for treating minor infections. Risks include tendon problems, muscle and joint pain, nerve damage, confusion, hallucinations, and more. Click here to read more.
FDA: Risks Outweigh Benefits for Common Infections
May 12, 2016 — The FDA is warning that the risk of disabling side effects from Factive outweighs its benefit for some of the most common infections. The agency is also asking patients to seek immediate medical attention if they develop side effects:
“Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.”
What is Factive?
Factive (gemifloxacin) is an antibiotic medication in the fluoroquinolone class of antibiotics. It was approved by the FDA in 2003 for the treatment of respiratory tract infections. It is one of the least-prescribed fluoroquinolone antibiotics.
What Does Factive Treat?
- Acute bacterial exacerbation of chronic bronchitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
- Community-acquired pneumonia: Caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.
Factive Side Effects
In clinical trials, at least 2% of patients reported side effects including diarrhea, rash, nausea, headache, abdominal pain, vomiting, and dizziness. Factive also carries a Boxed Warning about the risk of tendinitis (tendon inflammation) and tendon rupture (torn tendons).
Factive and Aortic Aneurysms
Fluoroquinolone antibiotics like Factive have been associated with many side effects involving connective tissue, including aortic aneurysms, tendon ruptures, and retinal detachments.
The aorta is the largest blood vessel in the body and an aneurysm occurs when a balloon-like bulge develops. Blood flowing through the aorta enlarges the aneurysm and can cause it to rip open (called aortic dissection) or rupture, resulting in severe internal bleeding.
Aortic aneurysms were linked to fluoroquinolone antibiotics in two recent studies. One study found a 2.4-fold increased risk within 60 days of taking a fluoroqionlone antibiotic. Conclusions were based on data from 150,000 people in Taiwan, including 1,500 who had an aortic aneurysm. Another study found a 3-fold increased risk of aortic aneurysm based on data from 650,000 people who took fluoroquinolone antibiotics.
Factive and Nerve Damage
Peripheral neuropathy causes sensory nerve damage that primarily affects the arms and legs. The most common symptoms include tingling or prickling sensations, numbness, weakness, and abnormal sense of touch (temperatures, textures, etc.).
The label on Factive and other fluoroquionolone antibiotics were updated to include peripheral neuropathy in 2004. However, the warnings were not strong enough. Some manufacturers assured doctors that patients who discontinued the drug would see their symptoms improve.
Unfortunately, studies published in 2001 warned that peripheral neuropathy usually occurred within less than a week and over 60% of cases persisted for at least a year. In 2014, Neurology published a study that found a doubled risk of peripheral neuropathy in men on fluoroquinolone antibiotics.
In 2013, the FDA updated risk information again, this time emphasizing the rapid onset of symptoms and possibly permanent side effects. The problem is that these warnings have come too late for many people who could have been prescribed a safer antibiotic.