To fight against constantly evolving gram-positive and gram-negative bacteria, drug scientists created the fluoroquinolone class of antibiotics. Despite thousands of synthesis attempts since 1962, only about a half dozen of antibiotics in this family have been approved for pharmaceutical use by the FDA. With each new iteration, attempts to broaden the treatment spectrum frequently failed to produce proven results that truly surpassed the effectiveness of the original formulas.
Furthermore, many of the produced drugs have been subsequently removed from clinical use due to their high incidence of side effects, with many others to potentially follow. Cases of aortic dissection and aneurysms, tendon ruptures, and peripheral neuropathy spurred recent lawsuits against the main drug manufacturers, Johnson & Johnson, and Bayer. Not only the side effects are under fire, but also the way the manufacturer downplayed patient claims of damage.
The most popular fluoroquinolone drugs on the market today include Cipro, Levaquin, and Avelox.
During the second generation, manufacturers developed Cipro to fight against systemic bacterial infections mainly in adult populations. This drug is only approved for childhood use in highly specific situations, including inhalation anthrax treatment.
To expand this antibiotic class’ range to treat Gram-positive Streptococcus bacteria, drug researchers created the third generation of fluoroquinolones, which includes Levaquin. This medication is often prescribed to clear up complicated urinary tract infections and pneumonia.
Avelox, from the fourth generation of medications, provides oral or intravenous treatment of potentially resistant infections. The dual stage medication targets two areas to slow the tendency to develop a resistance to the prescribed treatment, especially for long-term prescriptions.
Development of the fifth generation of drugs for this class are currently underway. The newest generation is designed to target
antibiotic-resistant bacteria, especially hospital acquired infections, like MRSA. The wide scope of treatment applications ensures continued growth and acceptance of these antibiotics, which already dominate more than 16% of the $43 billion drug market.
The antibiotics thoroughly kill bacteria colonies that cause severe infections in various systems throughout the body, including the digestive and respiratory systems.
Conditions commonly treated with fluoroquinolones include:
- Pelvic Inflammatory Disease
- Staph Infection
- Sinus Infection
Despite its prevalence and effectiveness, many people have suffered dangerous side effects from this class of medications. Upon receiving the medication from their doctors, patients were advised about potential common side effects, such as nausea, diarrhea, itching, and dizziness. A host of rare, yet serious side effects unexpected developed and quickly negated the benefits of utilizing the antibiotics to treat the original illness. Rare side effects include a chance of aortic dissection, aneurysm, tendon rupture and peripheral neuropathy.
Fluoroquinolones side effects
Pharmacological epidemiologist, Mahyar Etminan, at the University of British Columbia attains that the rare side effects cropped up in droves due to overuse of this antibiotic class for simple infections. Instead, doctors are urged to culture the bacteria in a lab to find and prescribe an ideal antibiotic instead of utilizing such a heavy hitter right out of the gates.
Short-term studies confirm the increased risk of debilitating side effects, resulting in black box warnings alerting medical practitioners and patients of the dangers. In addition to using lab cultures and alternate antibiotics for the first line of defense, doctors must carefully screen patients to identify individuals with a propensity to respond negatively to treatment with fluoroquinolones.
Aortic Dissection Danger
All generations of fluoroquinolones have the potential to cause aortic dissection to occur. Dissection is a slight tear in the aorta that allows blood to seep between the layers. Recent studies have revealed the connection between aortic dissection and these antibiotics. The research indicates that the antibiotics weaken collagen, which lines the aorta, eventually allowing the tissue to tear or even rupture. The majority of patients experience sudden onset tearing pain in the chest upon developing this condition.
Aortic Aneurysm Potential
The weak collagen can also allow an aortic aneurysm, or dilation of the aorta, to develop. An aneurysm does not usually have any warning signs, so the patient’s aorta may rupture without warning, resulting in a potentially fatal emergency situation. The break allows the aorta to bleed slowly, filling the body cavity and putting the patient at risk of death. A study released in JAMA Internal Medicine by researchers from National Taiwan University Hospital detailed the two-fold risk of developing aortic
dissection or aneurysms after taking fluoroquinolone antibiotics for any length of time. The increased risk seems to last for life.
Tendon Rupture Warnings
In 2008, the FDA marked all fluoroquinolone antibiotics with a black box warning indicating the increased risk of painful tendonitis and eventual tendon rupture. Patients with complicating risk factors, including advanced age, transplanted organs, and concurrent steroid therapy, face an additional increase in risk. Doctors must counsel their patients on warning signs of developing tendon damage, including pain and swelling, before prescribing these antibiotics. If any symptoms occur, patients must immediately switch to a different antibiotic and maintain close observation by a physician.
Peripheral Neuropathy Risks
After patient reports of peripheral neuropathy, or permanent nerve damage in the hands and feet, were cataloged by their doctors, the FDA chose to update the warning on fluoroquinolones to include this condition.
Symptoms associated with this condition include:
- Burning Pain
- Muscle Twitching
- Impaired Balance
- Coordination Disruptions
- Difficulty Walking
Lawyers representing these patients provided the court with proof that the drug manufacturers not only knew of the peripheral neuropathy risks but also decided to hide that information from medical professionals and the general public.
Lawsuits On File
Since its inception, Levaquin alone has heavily contributed to the demise of more than 5,000 people and injured 80,000 more. Including the injurious or deadly side effect incidents from the other fluoroquinolone antibiotics multiplies those statistics several times over. Patients have started to work with lawyers to file lawsuits through the court to collect damages for pain and suffering, lost wages and loss of life. The lawsuits may also address the lack of warning about increased aortic dissection or aneurysm risks for antibiotics in this class.
With thousands of cases completed and hundreds more pending, lawyers continue to invite affected patients to join the lawsuits against Johnson & Johnson to pursue damages. Since Bayer handles the production of Avelox, patients injured by that drug file their case against that particular manufacturer. The cases against Johnson & Johnson have escalated to federal court, while the ones pending for Bayer remain in the state systems.
Although the settlement amounts remain confidential, proving the damage resulted from taking fluoroquinolone drugs can net a full compensation package. Since the pharmaceutical companies claim the medications are safe for usage, even in high-risk populations, incidents will continue as long as this class of antibiotics remains on the market. The failure to warn the public about the risks may be viewed as negligence or fraud, which confirms the manufacturers’ liability for the resulting damages.