Need a Texas Factive Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with nerve damage or an aneurysm, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: FDA Strengthens Warnings for 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: Factive Risks Outweigh Benefits for Common Infections
May 2016 — Due to the risk of disabling side effects, the FDA is warning against prescribing Factive for people with sinus infections, bronchitis, or uncomplicated urinary tract infections when they have other options. Click here to read more.
The FDA also recommends that patients seek emergency medical attention if they develop severe 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 a prescription antibiotic that is approved for the treatment of bacterial infections, including respiratory infections like bronchitis and pneumonia. It is one of the least-prescribed members of a class of drugs known as fluoroquinolone antibiotics.
Factive is indicated for the treatment of the following types of infections:
- 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 and Aortic Aneurysms
Factive and other fluoroquinolone antibiotics can damage collagen and cause connective tissue side effects like tendonitis and tendon ruptures. They have also been linked to a possible increased risk of aortic aneurysms.
The wall of the aorta is made of collagen and an aneurysm occurs when a weak spot allows a balloon-like bulge to develop. If the bulge grows very large, the aorta can rip open and cause bleeding within the aortic wall (called dissection) or severe internal bleeding inside the body.
Two recent studies have found a 2- to 3-fold increased risk of aortic aneurysm within 60 days of taking a fluoroquinolone antibiotic. These studies include one published by researchers in Taiwan in October 2015, based on data from 150,000 people. In November 2015, another study found an increased risk of aortic aneurysm based on data from 650,000 people who used quinolone antibiotics.
Factive and Peripheral Neuropathy
In 2013, the FDA warned that all fluoroquinolone antibiotics, including Factive, may increase the risk of rapid, debilitating, and permanent nerve damage.
This rare but serious side effect is known as peripheral neuropathy. The FDA first warned about the risk in 2004. However, some manufacturers claimed that the side effect would improve when the antibiotic was discontinued.
In fact, studies published as early as 2001 have found that over 80% of people have symptoms within one week, and over 60% of people still have symptoms after one year. In 2014, the journal Neurology conducted a study of over 1 million people and concluded that fluoroquinolone antibiotics double the risk of peripheral neuropathy.
People with peripheral neuropathy typically have nerve damage that interferes with signals between the brain and limbs. They may experience muscle weakness, numbness, tingling or prickling sensations, chronic pain, and abnormal sense of temperature or texture.
Most Common Side Effects of Factive
According to the Prescribing Information for Factive, at least 2% of patients in clinical trials experienced side effects like diarrhea, rash, nausea, headache, abdominal pain, vomiting, and dizziness.
Factive Boxed Warning: Tendonitis and Tendon Ruptures
The label on Factive carries a “Black Box” warning — the strongest warning the FDA can require — about the risk of tendon injuries. They primarily affects the Achilles tendon and may require surgery. Injuries in the shoulder, hands, bicep, thumb, and other sites have been reported. According to the label:
“Fluoroquinolones, including Factive, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.”
Need a Factive Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Factive lawyers for a free lawsuit review.