Since 2004, researchers have known that Factive (generic: gemifloxacin) and other antibiotics from the fluoroquinolone class may increase the risk of peripheral neuropathy, a severe and potentially irreversible form of nerve damage. Factive has also been linked to tendon ruptures, tendinitis and aortic aneurysm.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Factive, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Fluoroquinolone Antibiotics May Cause Fatal Heart Damage, FDA Warns
December 21, 2018 – Fluoroquinolones could increase the risk of an aortic dissection, and people who are already at risk should be cautious about taking these medications, the U.S. Food & Drug Administration (FDA) warned in a Drug Safety Communication issued on Thursday.
“A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta,” the agency said. “These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.”
Factive Linked to Peripheral Neuropathy: FDA Warning
In August 2013, the FDA issued a warning which stated that Factive and other antibiotics in the fluoroquinolone class may have the potential to cause a severe form of nerve damage called peripheral neuropathy. The agency announced that it was requiring manufacturers of these drugs to revise their labeling and Medication Guides to better explain the symptoms of neuropathy, and to highlight how quickly the disease can develop.
According to the warning, “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.”
In addition to Factive, other fluoroquinolone antibiotics that may cause peripheral neuropathy include Avelox (moxifloxacin), Cipro (ciprofloxacin), Floxin (ofloxacin), Levaquin (levofloxacin) and Noroxin (norfloxacin).
What is Neuropathy?
Peripheral neuropathy is characterized by damage to the peripheral nerves, the nerves in the fingers and toes. When these nerves become damaged, they don’t function properly. Patients with peripheral neuropathy have decreased or abnormal sensation in their toes and fingers. In some cases, they develop problems moving these parts of the body as well.
Signs and symptoms of peripheral neuropathy may include:
- Change in sensation to light touch, pain, or temperature
- Change in sense of body position
- Loss of reflexes
- Muscle wasting
Fluoroquinolone Antibiotics Linked to Aortic Aneurysm & Dissection
A study published in JAMA Internal Medicine in October 2015 found that fluoroquinolone antibiotic medications like Factive may cause the aorta — the main artery in the human body — to become dangerously enlarged. For the study, researchers from National Taiwan University’s Department of Emergency Medicine looked at data on 1,477 patients who had been hospitalized for aortic aneurysm or dissection from January 2000 through December 2011, and compared them to a control group of 147,700 patients who had not been hospitalized. The findings suggest that current fluoroquinolone use increased the aortic aneurysm risk by more than double. 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.”
Aortic Aneurysm Symptoms
Aortic aneurysms often grow slowly over time with few if any recognizable symptoms. As the aneurysm grows, however, some patients may experience a pulsating sensation around their navel. Pain in the back, abdomen or side may be signs of impending rupture, according to the Mayo Clinic.
New Warning on Factive and Other Fluoroquinolone Antibiotics
May 12, 2016 – The U.S. Food and Drug Administration (FDA) issued a warning today against the systemic use of Factive and other fluoroquinolone antibiotics for the treatment of certain infections in patients who have other treatment options, ordering the drug labels to be updated accordingly. The side effects of these drugs typically outweigh the benefits for patients with alternative treatment options, the agency said. These side effects include severe and potentially permanent damage to tendons, muscles, joints, nerves and the central nervous system (CNS).
About Factive Class Action Lawsuits
Although we are a nationally recognized class action firm, the Products Liability Litigation Group at our law firm has decided against the filing of a Factive Class Action Suit, and is currently filing individual claims on behalf of individuals and/or their family members who have been injured after taking Factive.
A class action is a type of lawsuit filed with the court on behalf of large group of people or “class” of individuals that have been injured or wronged. The class is represented by the law firm and the case is generally decided upon a single member of the class who is sometimes referred to as the “class representative or class rep.”
Why Our Law Firm Is Filing Individual Lawsuits Opposed To a Class Action
In some instances, a class action may offer some advantages, as they aggregate a large number of individualized claims into one representational lawsuit. The aggregation can increase the efficiency of the legal process, lower the costs of litigation and in some cases offer the solution to a common problem wherein small recoveries do not provide the incentive for any individual or law firm to file an individual lawsuit.
However, a class action suit can also be a detriment to many class members, as they are often forced into a blanket “low ball settlement” and higher attorney fees. At Schmidt & Clark, LLP we understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual Factive Lawsuits on their behalf.
Do I Have a Factive Lawsuit?
The Pharmaceutical 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 cases in all 50 states.
Free Confidential Case Evaluation: If you or a loved one has been injured 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.