What’s the Problem?
The antibiotic medication Factive has been linked to serious side effects including nerve damage (peripheral neuropathy), tendon damage, aortic aneurysm and aortic dissection.
What is Factive?
Factive (gemifloxacin) is a fluoroquinolone antibiotic that fights bacteria in the body. The drug is used to treat different types of bacterial infections in the lungs. Factive is made by LG Life Sciences, LTD., and was approved by the U.S. Food & Drug Administration (FDA) in April 2003.
Nerve Damage (Peripheral Neuropathy)
A study published in the Annals of Pharmacotherapy in December 2001 found that fluoroquinolone antibiotics like Factive can cause severe, long-term nerve damage involving multiple organ systems.
The researchers found that onset of peripheral neuropathy was rapid — 84% of cases occurred within one week of initiating treatment, 68% of cases occurred in 72 hours, and 33% occurred in 24 hours. More than 70% of patients had symptoms that persisted for at least three months, and 58% still had symptoms after one year.
FDA Warning on Factive
FDA has issued at least two warnings about the rapid onset of peripheral neuropathy and the risk of permanent nerve damage associated with fluoroquinolone antibiotics like Factive. The first warning came in October 2004, and it was updated in August 2013:
“The onset of peripheral neuropathy after starting fluoroquinolone therapy was rapid, often within a few days,” FDA said. “In some patients the symptoms had been ongoing for more than a year despite discontinuation of the fluoroquinolone. Several patients were continued on the fluoroquinolone drug despite the occurrence of neuropathic symptoms.”
Peripheral Neuropathy Symptoms
- A sensation of wearing an invisible “glove” or “sock”
- Burning sensation or freezing pain
- Sharp, jabbing, shooting, or electric-like pain
- Extreme sensitivity to touch
- Difficulty sleeping because of feet and leg pain
- Loss of balance and coordination
- Muscle weakness
- Muscle cramping/twitching
- Difficulty walking or moving the arms
- Unusual sweating
- Abnormalities in blood pressure or pulse
Aortic Aneurysm / Aortic Dissection
A study published in JAMA Internal Medicine in November 2015 found that fluoroquinolone antibiotics may cause the aorta — the largest artery in the human body — to become abnormally enlarged. Researchers from National Taiwan University’s Department of Emergency Medicine compared 1,477 patients who had been hospitalized for aortic aneurysm or aortic dissection from January 2000 to December 2011, and compared them to a control group of 147,700 patients.
The findings suggested that current fluoroquinolone use increased the risk for aortic aneurysm by more than double, and that past use increased the risk by nearly 50%.
“Use of fluoroquinolones was associated with an increased risk of aortic aneurysm and dissection,” the researchers concluded. “While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy.”
Another study published in BMJ Open in November 2015 looked at data on over 1.7 million older adults and found a roughly 3-fold increased risk of tendon rupture and aortic aneurysm among patients who took fluoroquinolone antibiotics.
The researchers aimed to confirm a previously established link between the medications and tendon rupture, as well as to investigate a “potentially lethal association between fluoroquinolones and aortic aneurysms.” Approximately 30% of patients in the study had filled at least one fluoroquinolone prescription in the last 30 days. These individuals were 3.13 times more likely to suffer a tendon rupture and 2.72 times more likely to suffer an aortic aneurysm compared to patients who did not take fluoroquinolones.
FDA Issues New Warning on Fluoroquinolone Antibiotics
In May 2016, the FDA required fluoroquinolone labels to be updated with a warning about an increased risk for damage to muscles, nerves and more. The agency said risks of the drugs may outweigh the benefits in patients with sinusitis, bronchitis and uncomplicated urinary tract infections.
Fluoroquinolone side effects may include damage to tendons, muscles, joints, nerves and the central nervous system. For patients with these conditions, fluoroquinolones should only be prescribed when there are no other treatment options, according to the FDA.
Factive Side Effects
- Peripheral Neuropathy
- Tendon rupture / damage
- Stevens-Johnson syndrome (SJS)
- Toxic Epidermal Necrosis (TEN)
- Central nervous system disorders
- Hypersensitivity reactions
- Loss of consciousness
- Cardiovascular collapse
- Life-threatening skin reactions
- And more
Dec 2001 – Annals of Pharmacotherapy study published
December 2001 – Study published in the Annals of Pharmacotherapy finds an increased risk of severe, long-term peripheral neuropathy with fluoroquinolone antibiotics.
Apr 2003 – Approved by the FDA
April 4, 2003 – Factive approved by the FDA.
Aug 2013 – FDA requires labeling
August 15, 2013 – FDA requires fluoroquinolone antibiotic labels to be updated with information about the risk of permanent nerve damage.
Nov 2015 – BMJ Open study published
November 2015 – Study published in BMJ Open links fluoroquinolones to a 3-fold increased risk of tendon rupture and aortic aneurysm.
Nov 2015 – JAMA Internal Medicine study published
November 18, 2015 – Study published in JAMA Internal Medicine finds that current fluoroquinolone use increased the risk of aortic aneurysm by more than double, and that past use increased the risk by nearly 50%.
May 2016 – FDA labeling requirement
May 12, 2016 – FDA requires the labeling of fluoroquinolone antibiotics to be updated with a warning about an increased risk of damage to muscles, nerves and more.
- ”Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study”. BMJ Open. November 18, 2015.
- “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone”. JAMA Internal Medicine. November 2015.
- “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection”. U.S. Food & Drug Administration (FDA). August 15, 2013.
- “Factive (Gemifloxacin Mesylate) Tablets Drug Approval Package”. U.S. Food & Drug Administration (FDA). April 4, 2003.
- “Peripheral neuropathy associated with fluoroquinolones”. Annals of Pharmacotherapy. December 2001.