The Timeline of the Fluoroquinolones Lawsuit

The timeline of the fluoroquinolones lawsuit extends from the first adverse event report through the current status of litigation. Fluoroquinolone antibiotics are a popular treatment for a wide range of bacterial infections, including respiratory infections such as pneumonia, urinary tract infections (UTIs), gastrointestinal infections, and more. They are also frequently used to treat hospital-acquired infections that are typically resistant to more traditional antibiotic treatments. Some of the most commonly prescribed fluoroquinolones are Cipro® and Avelox®, manufactured by Bayer; and Levaquin®, which is manufactured by Johnson & Johnson.

A handful of pills
Many fluoroquinolone patients have experienced troubling complications following treatment.

Unfortunately, these antibiotics carry the risk of some serious and potentially fatal complications. Studies have linked fluoroquinolones to tendon ruptures, aortic dissection and aneurysm, and peripheral neuropathy, which is an irreversible nerve damage that often results in a permanent disability. If you or a loved one has suffered from a serious complication after taking a fluoroquinolone antibiotic, you may be entitled to compensation for your injuries, economic hardships, and emotional suffering. Contact a pharmaceutical attorney today to discuss your case in detail and review your options for legal recourse against the manufacturers of these dangerous drugs.

Over 26 Million Prescriptions Each Year

Doctors write prescriptions for fluoroquinolone antibiotics to more than 26 million Americans each year. The extreme popularity of these drugs is closely tied to the wide range of illnesses they can treat. Fluoroquinolone antibiotics are effective in treating a vast majority of illnesses that are caused by bacterial infections, including:

  • Urinary tract infections (UTIs)
  • Respiratory infections such as pneumonia or bronchitis
  • Gastrointestinal infections
  • Infections of the bones or joints
  • Sexually transmitted infections (STIs)
  • Infections of the skin or soft tissues
  • Osteomyelitis
  • Bacteremia
  • Hospital-acquired infections, including staphylococcus

Despite their popularity, numerous studies have shown fluoroquinolone antibiotics, particularly Cipro®, Levaquin®, and Avelox®, are associated with an increased incidence of severe complications. These complications have prompted countless lawsuits against the drug manufacturers, in addition to several warnings by the US Food and Drug Administration (FDA).

Adverse Event Reports

Numerous adverse event reports have surfaced over the years regarding serious complications. Serious side effects reported include tendon ruptures, peripheral neuropathy, and aortic dissection and aneurysm.

Tendon Ruptures

Tendon injuries, including tendinitis and ruptured tendons, are especially common in patients taking a fluoroquinolone antibiotic. A ruptured tendon can cause excruciating pain and requires prompt medical treatment to avoid long-term damage. Surgical and nonsurgical treatments are available, depending on the location and severity of the injury. Most patients, however, require lengthy physical therapy and rehabilitation to regain the strength and use of those muscles.

Peripheral Neuropathy

Peripheral neuropathy is permanent nerve damage to the peripheral nerves, which can include the sensory nerves, motor nerves, or autonomic nerves. The specific nerves that are damaged will dictate the extent of the injury. Sensory nerve damage, for example, typically results in an inability to feel pain or extreme hot or cold temperatures. Motor nerve damage, however, can impact a patient’s mobility. Peripheral neuropathy is often extremely painful, and a combination of opiates and antidepressants are usually prescribed to help provide patients with relief from their symptoms. Unfortunately, some patients can become dependent or addicted to their opiate painkillers.

Aortic Dissection and Aneurysm

Aortic dissection is a tear in the aorta, or the major blood vessels that connect to the heart. An aortic aneurysm is an enlargement or bulge in this blood vessel. Both are extremely dangerous conditions that cause severe pain in the chest or upper back. If not treated immediately, aortic dissection or aneurysm can cause heart attack, stroke, significant internal bleeding, organ damage, and death. In most cases, these conditions are treated through surgery, and many require grafts, valve replacements, or stents, in addition to a lifetime of medications and regular imaging scans.

FDA Warnings and Safety Announcements

In July of 2008, the FDA began requiring a “black box” warning to all fluoroquinolone antibiotic medications. The “black box” warning is the strongest warning the FDA can require, and often is one of the last cautions before a drug is taken off the market. This step was intended to warn patients and their healthcare providers of the significant risks of tendon injuries, particularly tendinitis and tendon rupture, associated with these medications. The FDA also included information to alert healthcare providers and patients that certain factors or conditions could put a patient at an even greater risk for tendon complications. This warning also cautioned healthcare providers against over-prescribing these medications.

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The FDA issued a safety announcement in August 2013 regarding the risk of peripheral neuropathy associated with fluoroquinolones. The FDA recommended updating the safety warnings on all fluoroquinolone medications to include the serious risk of peripheral neuropathy and permanent nerve damage. The announcement included signs and symptoms of peripheral neuropathy, and instructed patients to immediately discontinue use of any fluoroquinolone antibiotic if they experienced any of these side effects.

In May 2016, the FDA issued a Drug Safety Communication stating that “the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.” In addition to this statement, the FDA is requiring updates to the “black box” warnings to include the potential for permanent damage.

Scientific Studies

A study published in 2001 in the Annals of Pharmacotherapy, found that over 33 percent of fluoroquinolone patients develop symptoms of peripheral neuropathy within just 24 hours, while more than 58 percent develop symptoms within 72 hours, and more than 84 percent of patients develop symptoms within a week.

A study published in a 2014 issue of Neurology studied men between the ages of 45 and 80 years old over the course of ten years. Researchers found that patients who took a fluoroquinolone antibiotic were almost twice as likely to develop peripheral neuropathy as patients who were treated with a different type of medication.

Two separate studies in 2015 - one published in the Journal of the American Medical Association (JAMA) and another in the British Medical Journal (BMJ) - found that collagen damage caused by fluoroquinolone antibiotics could lead to aortic dissections and aneurysms. The study in JAMA found that patients were twice as likely to develop a dissection or aneurysm within 60 days of treatment. The BMJ study found patients were nearly three times as likely to develop an aneurysm with fluoroquinolone treatment.

Individual Lawsuits Filed

Countless individual lawsuits have already been filed against the manufacturers of these dangerous drugs. In a lawsuit against Bayer, the manufacturer of Avelox®, a woman claims she developed nerve damage immediately following her ingestion of the drug. A woman who also developed peripheral neuropathy as a direct result of ingesting Levaquin® filed a separate lawsuit against Johnson & Johnson. These cases are still pending, and countless others have been filed.  

Schedule a Consultation

If you or a loved one has suffered a serious complication after taking a fluoroquinolone antibiotic such as Cipro®, Levaquin®, or Avelox®, contact a dangerous drug attorney today to schedule a complimentary consultation.

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