Fluoroquinolones are antibiotic drugs that treat a variety of bacterial infections. They are synthetic, or laboratory-made, and are considered to be broad-spectrum because they attack and kill a number of types of bacteria. There are several different types of fluoroquinolones, both brand name and generic and they represent 16.6 percent of all antibiotics used worldwide. More than 26 million Americans take fluoroquinolones every year to fight infections.
Most people tolerate fluoroquinolones well, with only minor or no side effects. However, over the years many concerns have been raised regarding the safety of these antibiotics. They have been connected to serious health problems like aortic aneurysms, tendon ruptures, and even serious nerve damage called peripheral neuropathy. Lawsuits are in the works against the various companies that make and market fluoroquinolones and if you have been harmed by these drugs, you could be a part of an important lawsuit.
Drugs in the Fluoroquinolone Class
The fluoroquinolone class of synthetic antibiotics is derived from natural quinolones found in plants and animals. They are the most widely types of antibiotics used in the U.S. and one of the most important classes of antibiotics around the world. The first drug in the class became available in the 1960s and the U.S. Food and Drug Administration (FDA) has since then approved the use of six different fluoroquinolone antibiotics to treat bacterial infections:
The first three in the list are the older fluoroquinolones, while the last three were developed later. Many other newer fluoroquinolones have been developed, but then withdrawn due to toxicity and other serious adverse events like liver and kidney failure. Some of the brand names for these generic compounds include Cipro, Levaquin, Avelox, Factive, Floxin, Proquin, and Noroxin.
What Fluoroquinolones Treat
Fluoroquinolones are broad-spectrum antibiotics, which mean they can treat infections caused by a number of types of bacteria including Legionella, Chlamydia, and Mycobacterium tuberculosis, among many others. Some of the infectious conditions treated with Fluoroquinolones are urinary tract infections, typhoid fever, infectious diarrhea, pneumonia, and anthrax.
How Fluoroquinolones Work
Fluoroquinolones are compounds that kill bacterial cells to fight infections. They do this by stopping the activity of important enzymes called DNA gyrase and topoisomerase. These two enzymes are necessary for bacteria to replicate their DNA. Without them, they cannot replicate, divide and create new cells. The drugs also have the effect of causing the DNA to fragment and break apart so that the cells they attack die.
For most people, fluoroquinolones are well-tolerated and can even be life-saving, especially in the case of pneumonia and other serious infections. Some of the common, but not serious or life-threatening side effects people experience while taking fluoroquinolones are diarrhea, nausea, vomiting, drowsiness, dizziness, insomnia, and headaches.
Fluoroquinolones should not be used in anyone who is allergic to them or in people who have or may be at risk for a heart arrhythmia. They should also not be used in women who are breastfeeding. The risk to an unborn fetus is not fully known, but fluoroquinolones are classified as drugs that pose a moderate risk. Pregnant women may take them, but only if the benefits outweigh the risks.
Aortic Dissection and Aneurysm
Quinolones, including some of the fluoroquinolones that have been withdrawn from the market, have been shown to have adverse cardiovascular effects. These drugs are known to prolong the QT interval, an interval during the electrical cycle of the heart. When this interval is prolonged, it can lead to an arrhythmia and sudden cardiac arrest and death.
Fluoroquinolones specifically have been found to increase the risk of aortic aneurysms and dissections. One study found that the risk was doubled within the 60 days after patients taking any type of fluoroquinolone. An aortic dissection is a tear in the aorta, the body’s largest blood vessel that carries blood from the heart to the rest of the body. A tear in the aorta can lead to a stroke, a heart attack, organ failure, and death. An aortic aneurism is a rupture in the aorta that can cause sudden death.
More than one study has found that the risk of experiencing either of these serious and possibly deadly conditions is significantly increased in people taking fluoroquinolones. It is thought that the drugs cause collagen, a structural material, to break down in the body. Collagen lines the inside of the aorta, and when it breaks down it weakens the blood vessel, making tears and ruptures more likely.
Tendinitis and Tendon Rupture
It is this breakdown of collagen that may cause another adverse effect of taking fluoroquinolones. The possibility of developing tendinitis or of having a tendon rupture has warranted the FDA to issue a black box warning for all fluoroquinolones. Tendons are connective tissues that attach muscles to bones. Tendinitis is a swelling in the tendon. A rupture is a complete break in the connecting tendon.
The black box warning about tendinitis and tendon rupture states that the risk is highest for patients over the age of 60, in those taking steroids, and in patients who have had kidney, lung, or heart transplants. The warning also recommends that patients taking fluoroquinolones be aware of signs of tendon problems: pain, swelling, and inflammation in the joints. Any sign of a tendinitis or a tear should be reported and treated immediately.
Yet another serious risk of using fluoroquinolones is peripheral neuropathy, or damaged nerves. The FDA issued a warning about the risk in 2013 and required that all labels include an updated warning about it. Topical fluoroquinolones are not included, but injectable and oral forms of all the drugs in the class are now known to be associated with this condition.
The FDA recommends that anyone showing signs of peripheral neuropathy while on a fluoroquinolone should discontinue use right away and be switched to a non-fluoroquinolone antibiotic. Signs of peripheral neuropathy include tingling, numbness, weakness, pain, a burning sensation, or a change in sensation in the legs or arms.
Peripheral neuropathy has been listed as a possible side effect on fluoroquinolone since 2004, but after additional research the FDA decided the warning wasn’t strong enough. Some people have been reported to have lasting nerve damage and to become disabled after taking fluoroquinolones.
Because of the many possible risks of taking fluoroquinolones that have arisen over the last decade or so, many patients have suffered and felt that they were not adequately warned before taking the medication. In addition to the aortic aneurysms and dissections, the peripheral neuropathy, and the tendon issues, people have reported other adverse effects. These include detached retinas, ear ringing, dry mouth, shaking, muscle spasms, and delayed urination. In very rare cases patients have been reported to experience hallucinations and psychosis after taking fluoroquinolones.
All of these problems, both those warned against and well-documented, and those that have not been researched well yet, have led to numerous lawsuits against the companies that make and market fluoroquinolones. Thousands of lawsuits have been started by people who claim these companies did not warn patients and doctors adequately, that they committed fraud and hid the most serious risks, and that they are liable for the damage they have caused. If you have been harmed by fluoroquinolones, there is still time to start or join a lawsuit.