Avelox — Fluoroquinolone Antibiotics
Antibiotics are one of the most important medical discoveries in our history and save lives every day. Avelox is a type of antibiotic called a fluoroquinolone and is among the most prescribed in the country. It is used to treat a number of common infections, including bronchitis, sinus infections and urinary tract infections. There are thousands of Avelox prescriptions filled each year, but the drug and others in its class have been linked to serious and debilitating side effects. These include tears, bulges and ruptures in the body’s main artery, tendon damage and severe nerve damage. The FDA has warned about Avelox’s potential risks in the past, but in 2016, the agency advised physicians not to prescribe Avelox for common infections unless there were no other treatment options available. People who took Avelox and developed severe complications or side effects are now filing lawsuits against Bayer, the drug’s manufacturer.
Avelox (moxifloxacin) is a popular antibiotic and is frequently prescribed in the U.S. But the drug has been linked to a number of serious injuries, including aneurysms and tears in the body’s main blood vessel. The FDA now warns that Avelox should only be prescribed in cases of severe bacterial infection.
People who were harmed by Avelox are filing lawsuits against Bayer, the manufacturer of Avelox, seeking compensation for their injuries. There may be significant settlements or cash payouts to those affected by the drug.
If you took Avelox and experienced an aortic aneurysm or tear in your aorta, you may be able to file an Avelox lawsuit of your own.
Avelox lawsuits accuse Bayer of a number of legal claims, including:
- Designing a defective product
- Failing to warn about its risks
Lawyers and attorneys are actively accepting Avelox 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 Warns Avelox Risks Outweigh Benefits
Avelox is a popular antibiotic belonging to a class of drugs called fluoroquinolones. It is used to treat a number of infections, including common ones like sinus infections, bronchitis and urinary tract infections (UTIs).
Avelox is a powerful antibiotic that has been linked to serious and potentially debilitating side effects, including aortic aneurysms, aortic dissection (a tear in the aorta), tendon damage and rupture, and severe nerve damage in the arms and legs.
The FDA changed its prescribing recommendations for Avelox and updated the drug’s black box warning in 2016 because of the risk for potential side effects. The agency issued safety communications in May and July 2016 warning that the drug’s potential risks did not outweigh the 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 FDA analyzed adverse event reports related to Avelox and determined harmful side effects could start at any time during treatment, even within hours of taking the first dose. In many cases, patients developed multiple side effects at once and said they lasted up to weeks, months or even years. The FDA warned that some side effects, like nerve damage, could be permanent.
The federal agency advised health care professionals not to prescribe Avelox to patients being treated for uncomplicated sinus and urinary infections or bronchitis if they had other treatment options.
The FDA also updated Avelox’s black box warning — the FDA’s strongest warning — to call attention to the drug’s risks.
Black Box Warning
The FDA added a boxed warning to the labels of Avelox and all other fluoroquinolone antibiotics in 2008. The warning outlined the serious risk of tendinitis or tendon rupture that could occur in patients taking the drugs.
In July 2008, the agency released a safety communication warning of the risk, saying patients taking Avelox or other drugs in its class could experience pain, swelling, inflammation or tears in their tendons. Though the drugs could affect any tendon in the body, the injuries usually occurred in the hand, shoulder or, most often, the Achilles.
The FDA advised patients to call their doctor right away if they experienced symptoms like tendon pain, swelling or inflammation, as they could be signs of tendon rupture.
The agency also warned that some patients were at greater risk for tendon problems when taking Avelox 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.
Avelox’s boxed warning was updated again in 2016 after the FDA changed its prescribing recommendations for the drug. The change came following an analysis of adverse event reports that showed problems like tendon rupture, severe nerve damage and aortic aneurysms occurring in otherwise healthy people.
As a result of its analysis, the FDA said Avelox should be reserved for serious bacterial infections or for patients who have no other treatment options. The risk for severe complications outweighed the benefits of using Avelox in patients being treated for uncomplicated infections, like sinus infections, UTIs and bronchitis, the FDA said.
What is Avelox?
Avelox is a popular antibiotic used to treat a number of different infections. It is frequently prescribed to patients in the U.S. In 2014, there were over 260 million oral antibiotic prescriptions filled in pharmacies nationwide, about 32 million of which were prescriptions for fluoroquinolones like Avelox.
Antibiotics are lifesaving drugs and millions of people use them each year to fight bacterial infections. But overuse of these potent drugs can lead to antibiotic resistance and makes future infections harder to fight. Antibiotics are only effective against bacterial infections — they do not treat viral infections like the flu or the common cold.
Avelox belongs to a class of antibiotics known as fluoroquinolones. These powerful drugs work by targeting specific enzymes in bacteria cells to kill them or stop them from reproducing. Fluoroquinolones are effective in treating many different types of infections, from bronchitis to the plague.
Avelox was approved by the FDA in 1999 and is available as an oral tablet or injection. Avelox is approved to treat a number of illnesses, but the FDA has changed its recommendations for the powerful drug in light of recent safety concerns.
Avelox has been associated with a number of serious and debilitating side effects, including problems in the aorta, the body’s main artery that supplies oxygenated blood to the circulatory system. Avelox has been linked to problems like aortic aneurysms (bulges in the aorta that can possibly rupture) and aortic dissection (tears in the aorta that cause dangerous bleeding).
People who took Avelox and developed these side effects are now filing lawsuits against the drug’s manufacturer, Bayer, accusing the company of failing to warn about Avelox’s potential risks.
Common Uses of Avelox
Hundreds of millions of antibiotic prescriptions are written each year to treat a number of different bacterial infections. A relatively large percentage of these are written unnecessarily and contribute to the epidemic of antibiotic resistance. However, there is no doubt antibiotics are essential medicines and, when used properly, are effective in treating infections that could otherwise be dangerous or even deadly.
Some of the illnesses Avelox is used to treat include:
- Sinus infections
- Urinary tract infections (UTI)
- Abdominal infections
- Skin infections
Serious Side Effects
Avelox has been associated with a number of serious side effects and the FDA has issued several safety communications regarding the drug in the past decade. According to the FDA, these side effects can develop at any time during treatment and can last for months, years or even be permanent.
Some of the most serious side effects associated with Avelox include:
- Aortic aneurysm
- Aortic dissection
- Peripheral neuropathy
- Tendonitis/tendon rupture
Other rare, but serious side effects are possible when taking Avelox or other fluoroquinolones. These include seizures, hallucinations, depression, heart rhythm changes, intestine infection with diarrhea, liver damage, kidney damage, bone marrow damage, and blood sugar changes.
An aortic aneurysm is an abnormal bulge in the wall of the aorta — the main artery that supplies the circulatory system with oxygenated blood — and is caused when pressure pushes on a weak spot in the artery. If an aneurysm ruptures, it could cause dangerous internal bleeding and even lead to death. Every year, about 13,000 people die from aortic aneurysms in the U.S.
Peer-reviewed studies published in the past couple years have shown that fluoroquinolones like Avelox can lead to aortic aneurysms. Researchers believe these drugs may break down collagen in the body. Since the lining of the aorta is made up of mostly collagen, it could explain why aneurysms are a possible side effect of Avelox.
Aortic aneurysms often don’t cause any signs or symptoms until they burst. This makes them especially dangerous because a ruptured aneurysm could be fatal.
If a person does experience symptoms of an aneurysm, those symptoms depend on where the aneurysm is located. The two most common places for an aortic aneurysm to form are 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.
An aortic dissection is a tear that occurs in the lining of the aorta. When a tear occurs, blood leaks in between the layers of the artery and causes potentially dangerous bleeding. A dissection can be fatal if not treated right away.
Symptoms of aortic dissection can often mimic those of other serious 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
Avelox and other fluoroquinolones have been associated with aortic aneurysms and dissection, but other conditions may put people at risk for these problems too.
Other conditions that increase the risk for aortic aneurysm and dissection include:
- Uncontrolled high blood pressure
- Hardening of the arteries
- Marfan syndrome
- Connective tissue disorders
- Inflammation or infections
- Prior aortic aneurysm
Avelox can put people at an increased risk for damaged or ruptured tendons. Tendons are what connect your muscles to your joints.
The FDA required a black box warning be added to the labels of Avelox and other fluoroquinolones in 2008. The agency also issued a safety communication to warn physicians and the public about the potential risk.
Avelox 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 have a higher 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 said physicians should take patients off of Avelox at the first sign of tendon pain, swelling or inflammation. The agency also said people who experience these signs should avoid exercise or using the affected area as much as possible.
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
Avelox and other fluoroquinolones were the subject of increased scrutiny again in 2013 when the FDA warned the drugs could potentially cause severe nerve damage called peripheral neuropathy. As a result, the agency strengthened warnings on the drugs’ labels.
Peripheral neuropathy is severe nerve damage that causes weakness, numbness and pain in the hands and feet. The condition can occur at any time during treatment with Avelox and can last for weeks, months, or years. In some cases, damage can be permanent.
The FDA advised physicians to stop treatment right away if a patient developed signs or symptoms of the serious condition. Signs of peripheral neuropathy include:
- Changes in sensation to light touch, pain or temperature, or the sense of body position
Studies on Aortic Aneurysm, Dissection Risks
Recent peer-reviewed studies have sought to analyze the risks of aortic aneurysm or dissection when taking Avelox and other fluoroquinolones. This includes two studies published in the prestigious Journal of the American Medical Association and British Medical Journal in 2015.
JAMA Internal Medicine
A study published in JAMA Internal Medicine in November 2015 found Avelox and other drugs in its class 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).
The study authors found current use of fluoroquinolones was associated with a two-fold increased risk for aortic aneurysm or dissection. Past use was also associated with an increased risk, but it was lower than that of current use.
A study published in BMJ found patients taking Avelox or other similar drugs were at an even higher risk of aortic aneurysm than the JAMA study.
The study, also published in November 2015, included more than 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 Avelox or another fluoroquinolone were at a nearly three-fold increased for aortic aneurysm compared to patients who did not take a similar antibiotic.
The study authors found that most of the patients who developed an aortic aneurysm did so after about 20 days of taking the drugs.
Other Types of Fluoroquinolones
There are many different brands of fluoroquinolones on the market today. Avelox is one of 6 FDA-approved fluoroquinolones available in the U.S. and all 6 carry roughly the same risks of serious side effects.
Other available fluoroquinolones besides Avelox include:
- Levaquin (levofloxacin)
- Cipro (ciprofloxacin)
- Cipro XR (ciprofloxacin extended release)
- Factive (gemifloxacin)
If a patient taking Avelox or another fluoroquinolone develops symptoms of serious side effects, the FDA recommends they stop treatment and speak with their doctor right away. If a patient still has an infection, their doctor may start treatment with another type of antibiotic.
There are many different kinds of antibiotics on the market today. These antibiotics do not carry the same risks of aortic aneurysm and dissection as Avelox and other fluoroquinolones.
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
Avelox label. (July 2016). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.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