Update: FDA Updates Boxed Warnings on Fluoroquinolone Antibiotics
July 26, 2016 – For the second time in less than 3 months, the U.S. Food & Drug Administration (FDA) has upgraded warnings on fluoroquinolone antibiotic drugs, saying they’re too strong to be used for sinus infections, bronchitis and simple urinary tract infections (UTIs). “While these drugs are effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system,” the agency said in today’s Drug Safety Communication.
What is Factive?
Factive (generic: gemifloxacin) belongs to a class of antibiotic drugs called fluoroquinolones that are used to treat bacterial infections. These medications work by inhibiting the activity of both the DNA gyrase and topoisomerase IV enzymes, thereby blocking the ability of bacteria to replicate. Factive is made by LG Life Sciences, and was approved by the FDA in April 2002.
Fluoroquinolone Antibiotics Linked to Aortic Aneurysm, Dissection
New research suggests that fluoroquinolone antibiotics like Factive may degrade collagen, placing users at risk of suffering aortic aneurysm and/or aortic dissection. A study published in JAMA Internal Medicine in October 2015 looked at data on 1,477 patients who were hospitalized with these conditions from January 2000 through December 2011, and compared them to 147,700 controls.
The findings suggested that fluoroquinolone use was associated with an approximately doubled risk for aortic aneurysm and dissection within 60 days of beginning treatment. Past use increased the risk by nearly 50%.
“Use of fluoroquinolones was associated with an increased risk of aortic aneurysm and dissection,” the study’s authors said. “While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy.”
Types of Aortic Aneurysm
An aortic aneurysm is an abnormal enlargement or bulging in the wall of the aorta, the largest artery in the human body. The bulging can develop anywhere along the aorta:
- Aneurysms that occur near where the aorta that runs through the abdomen are called abdominal aortic aneurysms (AAA).
- Aortic aneurysms that occur in the chest area are called thoracic aortic aneurysms (TAA).
The signs and symptoms of an aortic aneurysm depend on where the bulging occurs, and whether the aneurysm has ruptured or is affecting other parts of the body.
Symptoms of an abdominal aortic aneurysm include:
- Throbbing feeling in the abdomen
- Deep pain in the back or side of the abdomen
- Steady, gnawing pain in the abdomen that lasts for hours or days
Symptoms of a thoracic aortic aneurysm include:
- Pain in the jaw, neck, back or chest
- Coughing / hoarseness
- Shortness of breath
- Trouble breathing / swallowing
Nerve Damage (Peripheral Neuropathy)
In October 2004 and then again in August 2013, FDA warned about the risk of peripheral neuropathy and permanent nerve damage associated with fluoroquinolone antibiotics like Factive:
“The onset of peripheral neuropathy after starting fluoroquinolone therapy was rapid, often within a few days. 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.”
According to the FDA, signs and symptoms of fluoroquinolone-induced peripheral neuropathy may include:
- Other alterations in sensations including light touch, pain, temperature, position sense, and vibratory sensation
Factive Side Effects
- Peripheral neuropathy
- Nerve damage
- Aortic aneurysm
- Aortic dissection
- Collagen disorders
- Muscle weakness
- Tendon ruptures
- Central nervous system disorders
- Cardiovascular collapse
- Life-threatening skin reactions
- Toxic epidermal necrolysis (TEN)
- Stevens-Johnson syndrome (SJS)
- Clostridium difficile associated diarrhea
- And more
Factive Class Action Lawsuit Information
No class action lawsuit has been filed over injuries allegedly caused by Factive or any other fluoroquinolone antibiotic. Instead, our lawyers are reviewing potential individual claims on behalf of people who were injured by the drug. The problem with class actions is that they are not designed to maximize cash payouts for injured parties. Instead, class members are often forced into accepting a “low-ball settlement,” with attorneys taking a huge cut and dividing the remainder among every plaintiff in the class action. For this reason, we believe personal legal representation is the best way to seek justice and maximize compensation for people who were injured by Factive side effects.
Do I Have a Factive Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Factive lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you’ve been harmed by Factive side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.