Cipro Side Effects May Be Linked To Tendonitis, TEN, Peripheral Neuropathy Lawsuits; FDA Finds Cipro Not Appropriate for Some InfectionsThe lawyers at Parker Waichman LLP are offering free consultations to individuals who experienced tendon ruptures and tendonitis after treatment with the antibiotic, Cipro (ciprofloxacin). If you or someone you know suffered a tendon injury as a result of taking Cipro, we urge you contact one of our Cipro injury lawyers risk free.
Cipro is a member of the fluoroquinolone group of antibiotics prescribed to treat bacterial infections of the abdomen, bones, urinary tract, skin, and lower respiratory system. Health officials also prescribe Cipro to combat bronchial infections, typhoid fever, prostate gland infections, and tuberculosis. Cipro gained notoriety in 2001, when it was used to treat victims of anthrax attacks. As of 2011, more than 23 million patients were prescribed a fluoroquinolone by 2015.
Study Finds Increased Risk of Aortic Aneurysm, Dissection with Fluoroquinolones
In November 2015, a study published in the Journal of the American Medical Association (JAMA) Internal Medicine found that fluoroquinolone antibiotics are associated with an increased risk of aortic aneurysm and dissection. The aorta is the main artery of the body and it carries oxygen-rich blood from the heart to the rest of the body. An aortic aneurysm occurs when there is a bulge in this large blood vessel. The aneurysm occurs in areas that are weak and overstretched; if the aorta bursts, intense bleeding and death may quickly occur. An aortic dissection occurs when there is a tear in the inner layer of the aorta. This tear may deepen as blood surges through the aorta, potentially causing a separation (dissection) of the inner and middle layers of the aorta; this condition is often fatal.
Examples of fluoroquinolones on the market include: Lecaquin (levofloxacin), Cipro (ciprofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin (ofloxacin, and Fative (gemifloxacin).
Researcher Chien-Chang Lee, MD, of National Taiwan University Hospital, Douliou, Taiwan, and colleagues conducted the study using data from the Taiwan National Health Insurance Research Database (NHIRD). The authors noted that "fluoroquinolones have been associated with collagen degradation, raising safety concerns related to more serious collagen disorders with use of these antibiotics, including aortic aneurysm and dissection." Overall, use of fluoroquinolones was linked to a roughly doubled increased risk of aortic aneurysm and dissection within 60 days of taking the antibiotics.
"We found that use of fluoroquinolones was associated with an approximately two-fold increase in risk of aortic aneurysm and dissection within 60 days of exposure," the authors wrote. "Although our results cannot establish cause and effect, it is not likely that more detailed information on a larger population at relatively high-risk of aortic aneurysm or dissection will be available in the immediate future."
Researchers advised clinicians to be "vigilant for the appearance of aortic aneurysm and dissection in high-risk patients treated with fluoroquinolones."
The authors note that fatalities from aortic aneurysm and dissection have increased over the past several decades. Each year, roughly 15,000 Americans die from aortic aneurysm. The researchers note that the aortic wall is largely composed of collagen, and fluoroquinolones have been associated with collagen-related health problems. The FDA added a black-box warning-the agency's strongest warning-to fluoroquinolones in 2008 to include the risk of tendinitis and tendon rupture.
"Not only is tendon composed of collagen, collagen is also a major extracellular matrix component of the aortic wall," the researchers stated, according to MedPage Today. "As fluoroquinolones may induce degradation of collagen causing tendinopathy, this raises the concern that fluoroquinolones may cause or aggravate aortic aneurysm and dissection by a similar mechanism."
Aortic aneurysm and dissection is more likely to occur in patients with collagen defects, including those with Marfan syndrome or vascular Ehlers-Danlos syndrome.
To conduct the study, researchers analyzed data from 1,477 patients hospitalized for aortic aneurysm or dissection from 2000 through 2011. For the control group, 147,700 individuals were matched for age and sex who were not hospitalized for these conditions; 100 controls were associated per case patient. Findings showed a higher rise of aortic aneurysm and dissection among current, past, and prior-year users of fluoroquinolones. Female patients and patients over the age of 70 had a higher risk of aortic dissection and aneurysm, the study found.
Among the 1,477 case patients, 850 were diagnosed with aortic aneurysm and 662 were diagnosed with aortic dissection. Generally, these patients had a higher rate of cardiovascular disease compared to controls.
In the study, "current use" meant that a prescription for a fluoroquinolone was filled within 60 days of an aortic dissection or aneurysm. "Past use" was defined as filling a prescription between 61 and 365 days before an aortic aneurysm, and prior use refers to a fluoroquinolone prescription filled for three or more days at any time during the one-year period prior to an aortic aneurysm or dissection.
Although aortic dissection and aneurysm are relatively rare conditions, these findings have important implications because fluoroquinolones are increasingly used, the authors wrote. Researchers also wrote that, "Given the global burden of aortic aneurysm and dissection and the growing use of fluoroquinolones worldwide, well-designed studies in other populations, especially high-risk populations, should be conducted to validate our findings."
The authors concluded that, "Use of fluoroquinolones was associated with an increased risk of aortic aneurysm and dissection. While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy."
"There are risks and benefits for every drug, and this study may be telling us about another risk for this group of drugs," Richard Wunderink, MD told MedPage Today. "Resistance is certainly the biggest issue we face with the quinolones, but these other issues are concerning, even if they are uncommon." Dr. Wunderink, who was not involved in the study, is a professor of medicine and pulmonology at Northwestern University Feinberg School of Medicine in Chicago, Illinois and a spokesman for the American Thoracic Society.
According to the Mayo Clinic, most patients diagnosed with aortic aneurysms do not have symptoms. If the aneurysm gets larger and puts pressure on surrounding organs, however, the aneurysm may produce symptoms. If the aneurysm bursts, this may lead to death unless the patient receives immediate medical treatment. The patient will exhibit sudden, severe pain, an extreme drop in blood pressure, and go into shock.
The most common type of aortic aneurysms are abdominal aortic aneurysms. According to the Mayo Clinic, symptoms include:
- Belly pain or discomfort; pain may be constant, or come and go.
- Pulsating sensation in the abdomen.
- Pain in the chest, abdomen, lower back, flank; pain may spread to the groin, buttocks, or legs. Sensation may feel deep, gnawing, aching, or throbbing. Movement generally does not affect the pain but some positions may be more comfortable.
- Fever or weight loss (if an inflammatory aortic aneurysm is present).
- "Cold foot," in which the toe is painful and appears black or blue. This occurs if a blood clot occurs and gets lodged in the legs or feet.
Symptoms of a thoracic aortic aneurysm, which occur in the chest, include:
- Chest pain
- Back pain
- Cough or shortness of breath
- Pain or difficulty when swallowing
Following Committee Findings, Federal Regulators Say Fluoroquinolone Warnings Not Sufficient for Certain Infections
In November 2015, the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee found that fluoroquinolones did not carry sufficient safety warnings for treating specific infections, including sinus infections, infections associated with chronic bronchitis, and urinary tract infections (UTIs). The Committee's focus was on the potential risks of such drugs, which include Cipro and which agency staff indicated might include the inflammation and tearing of tendons, as well as peripheral neuropathy, which is a condition caused by nerve damage and may affect the extremities of the body.
The Committee voted 21 to zero that fluoroquinolone antibacterial drugs, which include Cipro, do not contain sufficiently strong labels for the treatment of acute bacterial sinusitis, they also voted 18 to two that the labels are insufficient for the treatment of acute bacterial problems that complicate chronic bronchitis in those who have been diagnosed with chronic obstructive pulmonary disease (COPD), and voted 20 to one that the labels do not carry sufficient warnings for the treatment of UTIs, according to confirmation by FDA spokeswoman Lyndsay Meyer. "This meeting provided valuable information and perspectives to help inform the FDA's decision-making processes," Meyer said, adding that, "The FDA plans to consider the input from Committee members and the public from the advisory committee meeting and determine what future actions may be appropriate."
Law360 pointed out that, antibiotics that fall under this category include Bayer Corp.'s Cipro, which was also the focus of a personal injury lawsuit brought by a patient and filed in Pennsylvania state court. The lawsuit alleged Cipro's warning label indicated that the development of peripheral neuropathy as a result of Cipro treatment is rare, despite scientific evidence that has established a clear association between Cipro and peripheral neuropathy. In the case of this lawsuit, the plaintiff alleged that she was prescribed Cipro in September 2002, used it as directed, and developed irreversible peripheral neuropathy. Bayer and Merck & Co. Inc. are facing similar lawsuits in Pennsylvania federal court over nerve damage caused by Avelox, about which the lawsuit states that the companies spent "enormous amounts of money" to promote as the "heir apparent" to Cipro.
A Belgian doctor first established a link between the fluoroquinolones and permanent nerve damage in 1992. In 2002, the agency placed Bayer on notice that many reports suggested such a relationship, according to Law360.
Federal Regulators Warn that Fluoroquinolone Antibacterial Drugs, Such as Cipro, Should be Restricted for Certain Infections
In May 2016, the FDA issued a warning indicating that the serious and significant effects tied to fluoroquinolone antibacterial drugs, such as Cipro, generally outweigh the benefits of these drugs for patients who have been diagnosed with sinusitis, bronchitis, and uncomplicated UTIs, and who have other treatment options for these infections. For patients who have been diagnosed with any of these conditions, fluoroquinolones such as Cipro, should be reserved for those patients who have no other alternative treatment options for these infections.
The FDA safety review found that when fluoroquinolones are used systemically-in tablets, capsules, and injectable forms-they are associated with disabling and potentially permanent serious side effects that may occur collaboratively and may involve tendons, muscles, joints, nerves, and the central nervous system.
The FDA now mandates drug labels and "Medication Guides" for all fluoroquinolone antibacterial drugs be updated to reflect the new safety information. Cipro (ciprofloxacin) and Cipro extended release (ciprofloxin extended release), which are both available as generics, are included in the May 2016 FDA "Drug Safety Communication."
Cipro and Tendon Ruptures
Since its approval, our Cipro injury lawyers have heard from many individuals who suffered serious tendon injuries-including ruptures-as a result of treatment with Cipro. On November 8, 2003, a study conducted in Germany on lab rats revealed that the rats' Achilles tendons suffered degenerative alterations shortly after being given Cipro. In the study, ruptures continued to occur even after the rats stopped taking Cipro.
In January 2008, the consumer advocacy group, Public Citizen, filed a lawsuit against the FDA in an attempt to compel the agency to act on a petition it filed 16 months prior requesting that new warnings be added regarding side effects of Cipro and other antibiotics, which could increase the risk of tendonitis and tendon ruptures. At the time of the filing, Public Citizen said the FDA had received reports of at least 336 individuals who experienced a tendon rupture after using Cipro. The most common tendon rupture involved the Achilles tendon.
Finally, in July 2008, the FDA directed the maker of Cipro to add a black box warning to the drug's label about is association with tendon damage. The FDA indicated that Cipro and other fluoroquinolones had been associated with tendonitis and tendon ruptures. The risk is greatest for those over the age of 60; those on concomitant steroid therapy; and those who received a kidney, heart, and/or lung transplant.
The FDA warned that Cipro treatment should be stopped if a patient experiences pain or inflammation in a tendon (symptoms that may precede rupture of the tendon), or tendon rupture. Health care professionals were told to advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking Cipro, to avoid exercise and use of the affected area, and to promptly contact their health care provider about changing their medication.
Cipro and Toxic Epidermal Necrolysis
Our Cipro injury lawyers are also offering free consultation to anyone who developed Toxic Epidermal Necrolysis (TEN) following therapy with Cipro. In May 2005, a warning was added to the label of Cipro regarding its association to TEN. TEN-also called Lyle's Syndrome-is a life-threatening skin condition that is frequently induced by a reaction to medications.
TEN affects many parts of the body, but it most severely affects the mucous membranes, such as the mouth and eyes. These severe symptoms are often preceded by one to two weeks of fever, and many victims at first believe they are suffering from a common upper respiratory tract infection.
When the rash appears, it may be over large and varied parts of the body, and it is usually warm and appears red. In hours, the skin becomes painful and the epidermis is easily peeled away from the underlying dermis. The mouth becomes blistered and eroded, making eating difficult and sometimes necessitating feeding via a tube through the nose or stomach. The eyes are affected, becoming swollen, crusted, and ulcerated.
TEN is often fatal. Patients with the disorder should be hospitalized and highly specialized nursing care is typically provided, often in an intensive care unit. In some situations, patients may be treated in a burn unit.
Cipro and Peripheral Neuropathy
People taking Cipro may experience Cipro neuropathy or Cipro peripheral neuropathy.
Peripheral neuropathy has been a listed adverse reaction of fluoroquinolone drugs since 2004, with reports of long-lasting nerve damage and disability in people who take these medications. Federal health officials issued a warning that they are updating the safety labels of antibacterial fluoroquinolone drugs, such as Cipro, to indicate serious side effects associated with the popular medications and announced that it ordered the makers of Cipro, and other antibacterial fluoroquinolone drugs, to update the medications' safety labels to "better describe" the side effect of peripheral neuropathy.
A prior FDA review revealed that the then-current warnings for fluoroquinolones were not adequate. The FDA's more recent alert mandates all drug labels and medication guides for fluoroquinolones be updated to better focus on the risk for serious and potentially irreversible peripheral neuropathy.
The symptoms of peripheral neuropathy usually start rapidly and within just a few days of beginning treatment with a fluoroquinolone, such as Cipro, but may occur at any time. Nerve damage symptoms associated with peripheral neuropathy may last months and may become permanent, even if the drug is stopped. Peripheral neuropathy involves damage to the nerves that transmit information to and from the brain, spinal cord, and body. Peripheral neuropathy damage interrupts the connection, creating varying symptoms depending on the nerves affected. Generally, symptoms are seen in the arms and legs.
The FDA warns that patients who begin to develop signs of peripheral neuropathy should immediately speak to their physicians about alternate forms of treatment. Some signs of peripheral neuropathy, according to the agency's warning statements, include:
- Shooting pain
- A change in sensation to light touch, pain or temperature, or the sense of body position
The FDA warning only deals with the oral and injectable forms of the drugs. These medications are also available in topical solutions that are applied to the ears and eyes. Risks of peripheral neuropathy in those applications are not present or do not necessitate a warning.
Legal Help for Victims of Cipro Injuries
If you or a loved one suffered a serious injury, such as neuropathy, a tendon rupture, or TEN, following use of a fluoroquinolone, such as Cipro, you may have valuable legal rights. Please fill out our online form or call1-800-YOURLAWYER (1-800-968-7529) to speak with an experienced Cipro injury lawyer about your case.