Cipro | Cipro Lawsuits

Cipro — Fluoroquinolone Antibiotics

Cipro is a popular antibiotic used to treat a number of common infections. Thousands of prescriptions are filled each year to treat bronchitis, sinus infections, urinary tract infections, and other common illnesses. Antibiotics are an essential medicine and save lives every day, but Cipro and other drugs in its class have been linked to serious and debilitating side effects. These include tears and ruptures in the body’s main artery, tendon damage and severe nerve damage. The U.S. Food and Drug Administration warned about the risks associated with Cipro and other fluoroquinolone antibiotics and told physicians not to prescribe them for common infections unless no other treatment options were available. People who took Cipro and experienced severe side effects are now filing lawsuits against Bayer, the maker of the drug.

Cipro Lawsuits

The commonly prescribed antibiotic Cipro (ciprofloxacin) has been linked to a number of serious injuries, including aneurysms and tears in blood vessels. The FDA is now warning that Cipro should only be prescribed in cases of serious bacterial infection.

People who were harmed by Cipro are filing lawsuits against Bayer, the drug’s manufacturer, seeking compensation for their injuries. There may be significant settlements or cash payouts to those affected by the drug.

If you took Cipro and experienced an aortic aneurysm or tear in your blood vessel, you may be able to file a Cipro lawsuit of your own.

Cipro lawsuits accuse Bayer of a number of legal claims, including:

  • Designing a defective product
  • Failing to warn about its risks
  • Negligence
  • Fraud

Lawyers and attorneys are actively accepting Cipro cases from claimants nationwide. These lawsuits are being filed individually and are not part of a class action lawsuit. The litigation is still in its early stages. No cases have gone to trial and no settlements or verdicts have been reached.

FDA says Cipro Risks Outweigh Benefits

Cipro is one of the most frequently prescribed antibiotics in the U.S. and is used for common illnesses like sinus infections and urinary tract infections (UTIs).

The potent antibiotic has been linked to serious and potentially debilitating side effects, including aortic aneurysms, aortic dissection (a tear in the aorta), tendon rupture and severe nerve damage in the arms and legs.

Cipro’s potential to cause such serious side effects prompted the FDA to change its recommendations for the antibiotic and to update its black box warning.

In a July 2016 Safety Communication, the FDA warned Cipro’s risks did not outweigh its benefits in patients being treated for sinus infections, bronchitis or UTIs.

“We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options … because the risk of these serious side effects generally outweighs the benefits …” the FDA wrote.

The side effects could start at any time during treatment, even within hours of taking the first dose, according to the FDA’s analysis of adverse event reports. Patients often developed multiple different side effects that could last for weeks, months or years; and some side effects, like nerve damage, could be permanent, the FDA warned.

The agency instructed health care professionals not to prescribe Cipro to patients being treated for uncomplicated sinus and urinary infections or bronchitis if they have other treatment options.

The FDA also updated Cipro’s black box warning to address the drug’s risks. Black box warnings are the FDA’s strongest warnings for a drug.

Black Box Warning

The FDA added a boxed warning to Cipro’s label in 2008 to highlight the risk of tendinitis or tendon rupture when taking the drug.

In a July 2008 Safety Communication, the FDA said patients taking Cipro and other fluoroquinolones could experience pain, swelling, inflammation or tears in tendons. These injuries generally happened in the hand, shoulder, or the Achilles.

The FDA said patients should contact their doctors immediately if they experienced symptoms like tendon pain, swelling or inflammation, as these could be signs of tendon rupture.

The agency also said some patients were at a greater risk for tendon problems when taking Cipro than others. This included patients who were over the age of 60, had a kidney, heart of lung transplant, or were undergoing steroid therapy at the same time.

Cipro’s boxed warning was updated in 2016 after the FDA changed its recommendations for the drug. The agency’s new recommendations came after its review of adverse event reports  detailing side effects like tendon rupture, severe nerve damage and aortic aneurysms occurring in otherwise healthy people.

The FDA said the risk for severe complications outweighed the benefits of using Cipro for uncomplicated infections, like sinus infections, UTIs and bronchitis, and said the antibiotic should be reserved for patients who have no other treatment options.

What is Cipro?

Cipro is a popular antibiotic used to treat a variety of different bacterial infections. It is among the most frequently prescribed antibiotics in the U.S.

Antibiotics are lifesaving drugs, but overuse can lead to antibiotic resistance and make future infections harder to fight. All antibiotics, including Cipro, are only effective against bacterial infections. Viral infections, like the common cold and flu, are not treatable with antibiotics.

Cipro belongs to a class of antibiotics called fluoroquinolones. These potent drugs work by targeting specific enzymes in bacteria cells and are effective in treating many different types of infections.

Cipro was approved by the FDA in 1987 and is available as an oral tablet or injection. Cipro is approved to treat a number of illnesses and infections, but the FDA has recently changed its recommendations for the powerful drug.

Cipro has been linked to a number of serious and sometimes debilitating side effects, including problems with the aorta, the body’s main artery that supplies oxygenated blood to the circulatory system. Cipro has been shown to cause aortic aneurysms, a bulge in the aorta, and aortic dissection, a tear in the aorta.

People who took Cipro and suffered complications are now filing lawsuits against drugmaker Bayer, accusing the company of failing to warn about Cipro’s risks.

Common Uses of Cipro

Millions of people use antibiotics every year to fight bacterial infections. In 2014, over 260 million oral antibiotic prescriptions were filled in U.S. pharmacies; about 32 million of those were fluoroquinolone prescriptions.

Doctors prescribe antibiotics for a number of different illnesses. Research has shown that a relatively large percentage of antibiotic prescriptions are unnecessary and contribute to the antibiotic resistance epidemic. But there is no doubt that antibiotics are essential medicines and, when used properly, are effective in treating various bacterial infections.

Some of the illnesses Cipro is used to treat include:

  • Bronchitis
  • Sinus infections
  • Urinary tract infections (UTI)
  • Bone and joint infections
  • Skin infections
  • Infectious diarrhea
  • Gonorrhea
  • Prostate infections
  • Abdominal infections
  • Typhoid fever

Serious Side Effects

The FDA has warned about the serious side effects related to Cipro in various safety communications issued in the past decade. These side effects can develop at any time during treatment with Cipro, some even within hours of taking the first dose.

Some of the most serious side effects associated with Cipro include:

  • Aortic aneurysm
  • Aortic dissection
  • Peripheral neuropathy
  • Tendonitis/tendon rupture

Other serious side effects are possible when taking Cipro and include seizures, hallucinations, depression, heart rhythm changes, intestine infection with diarrhea, liver damage, kidney damage, bone marrow damage, and blood sugar changes.

Aortic Aneurysm

An aortic aneurysm is an abnormal bulge in the wall of the aorta, the main artery that supplies the circulatory system with oxygenated blood. An aortic aneurysm is caused when pressure pushes on a weak spot in the artery. If the aneurysm ruptures, it could cause dangerous bleeding in the body and even lead to death. About 13,000 people die each year in the U.S. from aortic aneurysms.

Recent studies have shown that fluoroquinolones like Cipro can lead to aortic aneurysms. Researchers believe Cipro and other fluoroquinolones may break down collagen in the body. The lining of the aorta is made up of mostly collagen, which could explain why aneurysms are a possible side effect of Cipro.

Symptoms

Aortic aneurysms often don’t cause signs or symptoms until they burst. If an aneurysm does cause symptoms, they will depend on where the aneurysm is located. The two most common places for an aortic aneurysm to form is in the abdomen and the chest.

Symptoms of abdominal aortic aneurysms include:

  • A throbbing feeling in the abdomen
  • Deep pain in your back or the side of your abdomen
  • Steady pain in your abdomen that lasts for hours or days

Symptoms of an aneurysm that occurs in the chest cavity, called thoracic aortic aneurysms, include:

  • Pain in your jaw, neck, back or chest
  • Coughing or hoarseness
  • Shortness of breath or trouble breathing or swallowing

If an aneurysm ruptures you could experience sudden, sharp, stabbing pain where the burst occurred, nausea and vomiting, light-headedness and rapid heart rate. 

Internal bleeding from a ruptured aortic aneurysm can send the body into shock — a life-threatening condition in which blood pressure drops so low vital organs like the brain and kidneys can’t get enough blood to work. Shock can be fatal if it is not treated immediately.

Aortic Dissection

An aortic dissection is a tear that occurs in the lining of the aorta. The tear allows blood to leak in between the layers of the artery causing potentially dangerous bleeding. A dissection can be fatal if not treated promptly.

Symptoms of aortic dissection can mimic those of other serious, yet more common conditions, such as heart attack and stroke.

Aortic dissection symptoms include:

  • Sudden, severe chest or upper back pain
  • Loss of consciousness
  • Shortness of breath
  • Sudden difficulty speaking, loss of vision, weakness or paralysis on one side of the body
  • Weak pulse in one arm compared to the other

Other Causes of Aortic Aneurysm & Dissection

Aortic aneurysms and dissection are both possible side effects of Cipro, but other conditions may put people at risk for these problems too.

Other conditions that increase the risk for aortic aneurysm or dissection include:

  • Uncontrolled high blood pressure
  • Hardening of the arteries
  • Marfan syndrome
  • Connective tissue disorders
  • Inflammation or infections
  • Trauma
  • Prior aortic aneurysm

Tendon Rupture

Tendons connect your muscles to your joints. Cipro and other fluoroquinolones have been shown to damage tendons or cause them to rupture. The FDA required a black box warning on Cipro’s label and issued a safety communication in 2008 to warn physicians and the public about the risk.

Cipro can affect any tendon in the body, but damage most often occurs in the Achilles tendon, located at the back of the ankle. Some people are more at risk than others for tendon damage or rupture, including those who are:

  • 60 or older
  • Undergoing steroid therapy
  • Kidney, heart or lung transplant recipients

In its 2008 warning, the FDA told physicians to take patients off of Cipro at the first sign of tendon pain, swelling or inflammation. People who experience these signs should also avoid exercise and using the affected area, the agency said.

Symptoms of a damaged or ruptured tendon include:

  • Pain, swelling or inflammation
  • A snap or pop in the tendon area
  • Bruising right after injury in a tendon area
  • Inability to move the affected area or bear weight

Peripheral Neuropathy

Peripheral neuropathy is severe nerve damage that causes weakness, numbness and pain in the hands and feet. In 2013, the FDA warned that Cipro and other fluoroquinolone antibiotics could potentially cause peripheral neuropathy and strengthened warnings on the drugs’ labels. Peripheral neuropathy can occur at any time during treatment with Cipro and can last for weeks, months, years or even be permanent. The FDA advised physicians to stop treatment right away if a patient developed signs of peripheral neuropathy.

Signs and symptoms of peripheral neuropathy include:

  • Pain
  • Burning
  • Tingling
  • Numbness
  • Weakness
  • Changes in sensation to light touch, pain or temperature, or the sense of body position

Studies on Cipro Risks

Recent peer-reviewed studies show the risks of aortic aneurysm or dissection when taking Cipro or other fluoroquinolones. These include studies published in the prestigious Journal of the American Medical Association and British Medical Journal.

JAMA Internal Medicine

A study published in JAMA Internal Medicine in November 2015 found Cipro and other fluoroquinolones put current users at a two-fold increased risk for aortic aneurysms or dissections.

The study looked at more than 1,400 people who had surgery for an aortic aneurysm or dissection between 2000 and 2011. Researchers looked at current users of fluoroquinolones (those who filled a prescription within 2 months of surgery) and past users (those who filled prescriptions 2 months to 1 year before surgery).

Current use of fluoroquinolones was associated with a two-fold increased risk for aortic aneurysm or dissection, study authors found. Past use was also associated with an increased risk but the risk was lower than that of current use.

BMJ

A study published in November 2015 in BMJ found patients taking Cipro or other fluoroquinolones were at a nearly three-fold increased risk of aortic aneurysm.

The study looked at 1.7 million older adults, about 658,000 of whom took at least one fluoroquinolone antibiotic. Researchers recorded any collagen-related side effects suffered by patients, including tendon ruptures, retina detachments and aortic aneurysms, during the study period.

Researchers found that patients who took Cipro or another fluoroquinolone were at a nearly three-fold increased for aortic aneurysm compared to patients who did not take a similar antibiotic. Most patients who developed an aortic aneurysm did so after about 20 days of taking the drugs.

Other Types of Fluoroquinolones

Cipro is not the only fluoroquinolone antibiotic on the market today. There are 6 FDA-approved fluoroquinolones available, including Cipro and Cipro Extended Release. All 6 carry roughly the same risks of serious side effects.

Other available fluoroquinolones besides Cipro include:

  • Avelox (moxifloxacin)
  • Levaquin (levofloxacin)
  • Factive (gemifloxacin)
  • Ofloxacin

Alternatives to Cipro

If a person experiences serious side effects while taking Cipro or another fluoroquinolone, the FDA recommends they stop treatment and speak with their doctor right away. If there is still an infection to fight, doctors may start treatment with another type of antibiotic.

There are many different types of antibiotics on the market today that do not carry the same serious risks as Cipro and other fluoroquinolones. These antibiotics may be used to fight the infection instead.

Alternative antibiotics include:

  • Penicillins, such as penicillin and amoxicillin
  • Cephalosporins, such as Keflex
  • Macrolides, such as E-Mycin, Biaxin and Zithromax
  • Sulfonamides, such Bactrim and Proloprim
  • Tetracyclines, Sumycin, Panmycin and Vibramycin
  • Aminoglycosides, such as Garamycin and Tobrex

 

 

Sources

Cipro Label. (July 2017). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s086lbl.pdf

FDA Alert. “Information for Healthcare Professionals: Fluoroquinolone Antimicrobial Drugs [ciprofloxacin (marketed as Cipro and generic ciprofloxacin), …” (July 2008). Retrieved from https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm

FDA Safety Communication. “FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects.” (July 2016). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm

FDA Safety Communication. “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage…” (August 2013). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm365050.htm

FDA Safety Communication. “FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections…” (May 2016). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm

Mayo Clinic. “Aortic Dissection.” Mayo Clinic Staff (Oct. 28, 2014). Retrieved from http://www.mayoclinic.org/diseases-conditions/aortic-dissection/basics/definition/CON-20032930?p=1

Centers for Disease Control and Prevention. “Aortic Aneurysm Fact Sheet.” (June 16, 2016). Retrieved from https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_aortic_aneurysm.htm

National Heart, Lung, and Blood Institute. “What Are the Signs and Symptoms of an Aneurysm?” (April 1, 2011). Retrieved from https://www.nhlbi.nih.gov/health/health-topics/topics/arm/signs

Mayo Clinic. “Peripheral neuropathy – Symptoms and causes.” Mayo Clinic Staff. (July 7, 2016). Retrieved from http://www.mayoclinic.org/diseases-conditions/peripheral-neuropathy/symptoms-causes/dxc-20204947

EMedicineHealth. “Types of Antibiotics.” (Sept. 16, 2016). Retrieved from http://www.emedicinehealth.com/antibiotics/page2_em.htm

JAMA Internal Medicine. “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone.” Lee CC et al. (November 2015). Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/26436523

BMJ. “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study.” Nick Daneman et al. (November 2015). Retrieved from http://bmjopen.bmj.com/content/5/11/e010077.long