Recent studies, published by the American Medical Association and prominent medical journals, are concerned that the use of fluoroquinolone antibiotics, like Cipro, may be linked with a substantial risk for aortic aneurysms and aortic dissections.
Such health events can lead to fatal aortic ruptures. The available research warns that the use of antibiotics like Cipro (ciprofloxacin) could be associated with an increased risk after immediate treatment, or years after.
Aortic dissection is a life-threatening condition that occurs when the lining of the aorta—the main artery in the body—is broken down, allowing blood to seep into outside layers of tissue, quickly causing debilitating complications that often lead to death. When the aorta wall ruptures, patients have roughly a 50 percent chance of survival.
Medical scientists compiled data that shows the incidence of aortic dissection and aortic aneurysm in America has risen over the last 30 years, a primary cause of death each year for thousands of unknowing patients. The 2015 studies, published in the Pharmaceutical Journal, identify a logical “association” between fluoroquinolone (Cipro) use and the development of severe aortic disorders.
Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio pharmaceutical attorney, representing plaintiffs nationwide in a wide variety of wrongful death and injury claims.
Fluoroquinolone antibiotics are helpful in treating a wide variety of infections, but they also carry the potential to cause dangerous side effects like aortic aneurysms and dissections, as well as permanent nerve damage. Injured patients and attorneys have filed hundreds of lawsuits against major drug makers, claiming that the side effects they list as “rare” have been understated.
The fluoroquinolone class of antibiotics concerned U.S. health officials for the last decade. In 2008, the U.S. Food and Drug Administration (FDA) implemented a clear, boxed warning, stating the risks of tendinitis and tendon rupture on fluoroquinolone packaging. Cipro, Noroxin, Levaquin, and Moxifloxicin were among the drugs listed in that specific FDA warning.
Various reports and complaints mounted from doctors and patients, and in 2013 the FDA issued another warning regarding peripheral neuropathy (permanent nerve damage) as a notable “disabling” side effect of Cipro and other fluoroquinolones.
The government agency then recommended restricting the drugs’ use to a last resort for common infections. A recent research institute also suggested that more prudent use of the antibiotics could avoid countless aortic aneurysms.
The FDA statement reads: “Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options.” The agency goes on to say in some patients “the risks outweigh the benefits.”
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In 2015, a research team at the University of Toronto discovered an association between fluoroquinolone use and an increased risk of aortic aneurysm. The study concluded in clear terms: “Fluoroquinolone prescriptions can contribute acutely to aneurysm progression and rupture.”
Recent studies involving cardiac problems, published by the American College of Cardiology, are consistent with already established research and warnings. The newer data build on evidence that Cipro induces aortic aneurysm and dissection in the same way it damages collagen in tendons.
Medical officials urge that aortic aneurysms and dissections be diagnosed quickly, and that victims seek immediate medical attention if they experience the following symptoms:
• Sudden and intense abdominal, chest or back pain
• Migrating pain in the back or legs
• Dizziness and disorientation
• Nausea and vomiting
• Unusually high or low blood pressure
• Difficulty breathing
• Sudden difficulty speaking
• Loss of vision
• Weakness on one side of the body
Treating patients with fluoroquinolones like Cipro (ciprofloxacin) has been associated with an increased risk for aortic aneurysm or dissection, and several other serious conditions, including:
• Peripheral Neuropathy—permanent nerve damage
• Central nervous system disruption—convulsions, tremors and seizures
• Tendon rupture—often affecting lower extremities (Achilles)
• Retinal detachment
• Vision impairment and hallucinations
• Hypersensitivity
• Depression and anxiety
• Muscle weakness and fatigue
• Joint pain
• Liver damage (hepatotoxicity)
• Severe allergic reactions (DRESS)
The FDA public adverse reaction database lists tens of thousands of complaints naming Cipro and other fluoroquinolones for causing the conditions listed above.
The most recent updates from the FDA and other professional medical sources are predictable. These common drugs have a history of generating adverse health reactions. In 2013, the FDA warned that Cipro treatment could lead to nervous disorders like irreversible peripheral neuropathy. The warning said permanent nerve damage was possible in the arms, hands, legs and feet of patients.
Other serious complaints in the last few years have included severe allergic reaction (DRESS), risk of tendon rupture, and muscle spasms. Side effects can occur within hours to weeks after starting a fluoroquinolone course.
According to reported events, side effects continue for an average of 14 months, and can last as long as 9 years after stopping the medicines. Several cases reported the side effects worsened or continued after treatment stopped.
A 2015 study of nearly 2 million patients, published in the BMJ Open journal, found that within a month of finishing fluoroquinolone treatment, patients were more than twice as likely to experience aortic aneurysm as similar patients taking other courses of drugs.
Patients of all ages treated with Cipro could be at risk of developing dangerous cardiac problems, including aortic dissection. Available data suggest the duration of treatment could be a likely factor, though adverse reactions have been reported as soon as the first dose.
In November, 2015, the FDA’s Drug Safety and Risk Management Advisory Committee released a report on the damaging risks of antimicrobials like Cipro. The report includes several specific cases of injurious reactions that patients suffered during the treatment of fluoroquinolones.
Cipro (ciprofloxacin), manufactured and distributed by Bayer, is a popular broad-spectrum antibacterial agent used to treat bacterial infections, including the following:
• Sexual transmitted diseases
• Urinary tract infection
• Chronic prostate infection
• Lower respiratory tract infection
• Sinus infection
• Skin infection
• Bone and joint infection
• Pneumonia
• Intra-abdominal infection
• Infectious diarrhea
• Typhoid fever
• Inhalational anthrax
The U.S. Centers for Disease Control and Prevention (CDC) says about a third of antibiotics prescribed in the United States are “unnecessary.” Over 25 million Americans receive a prescription for a fluoroquinolone antibiotic like Noroxin, Cipro, Levaquin or Avelox each year.
Public health officials note that the widespread use of the drugs makes them a significant concern. Although fluoroquinolones like Cipro can be effective treatments for infections, alternate drugs or shorter courses should be considered. Patients who have received Cipro treatment should have been warned about a potentially lethal risk to the aorta.
Antibiotics like Cipro are prescribed to millions of Americans each year for urinary tract infections, pneumonia, bronchitis or other bacterial infections. Serious injuries following use have led to patients and their drug defect attorneys to file product liability claims and Cipro lawsuits.
Drug companies often put products to market before the results of long-term studies can confirm their safety for consumers. As a result, antibiotics and other classes of drugs are released and injure patients. When drug injury occurs, plaintiffs and consumer safety lawyers can file lawsuits and seek compensation for the damages caused.
By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.
When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit. Pharmaceutical litigation – through a lawsuit against a drug manufacturer- helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a certain drug.
By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.
In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit. As a result, there is a financial incentive not to strengthen the warning label.
However, the label is the source of information that physicians and patients rely upon when making these important health decisions. There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.
Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of medical devices that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.
While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.
Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product. The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.
Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.
Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.
Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.
The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts. While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.
The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.
Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.
Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.
In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.
It’s possible. Fluoroquinolones (which include ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause long-term, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system.
Quite common. Antibiotics may increase nerve damage and peripheral neuropathy risk. Fluoroquinolone antibiotics, such as Levofloxacin and Ciprofloxacin, appear to increase the risk of peripheral neuropathy by up to 47 percent.
The Lyon Firm aggressively, professionally, and passionately advocates for individuals and families against drug companies to obtain just compensation under the law.
This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.
A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.
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