Levaquin Tendon Side Effects Lawsuit Attorney
Levaquin Side Effects Levaquin Recall
Levaquin (levofloxacin), manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a fluoroquinolone antibiotic used to treat bacterial infections commonly associated with urinary tract, lung, sinuses, and skin. The drug first entered the market in 1997.
However, Levaquin has been linked to side effects such as tendonitis and tendon rupture in those taking the antibiotic. According to documents filed as part of Levaquin lawsuit proceedings, the Japanese pharmaceutical company, Daiichi Pharmaceutical Co. Ltd. which originally manufactured the drug, knew prior to its approval that the drug may cause tendon side effects such as Achilles tendon ruptures. The adverse side effects of Levaquin are not restricted to a particular age group, however tendon problems are more common among Levaquin users who are older than 60. Levaquin is a prescription antibiotic that may be prescribed in tablet or oral solution form. Normally, prescription usage is for a period not exceeding 28 days. In 2006, the consumer watchdog group, Public Citizen, called on the FDA to provide a black box warning for the antibiotic due to its association with tendonitis and tendon ruptures. The dangerous side effects have been well-known but not well documented since the 1980’s. Levaquin side effects lawsuits have since been filed.
“The numbers are startling. Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, and switched to other antibiotics,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The FDA must act and require black box warnings and patient information guides.”
According to Public Citizen’s own study of the data, 262 reported tendon ruptures, 258 tendonitis reports, and 274 of other tendon issues associated with the drug. The data compiled comprised the years between 1997 and 2005.
The tendon ruptures most commonly occur in the Achilles’ tendon. However, such ruptures are not restricted to the heel. Ruptures associated with the administration of Levaquin include the rotator cuff of the shoulder, the biceps, as well as tendons in the hand and thumb. A rupture could be the basis for a lawsuit.
In 2008, after receiving more than 1,000 adverse event reports concerning Levaquin, the FDA ordered the manufacturers of Levaquin to add a black box warning, the strongest FDA warning short of a drug recall. The warning states, “FDA ALERT [7/8/2008]: FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients. The addition of a boxed warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs.
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.
Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.”
The FDA has noted that 60% of all quinolone-related tendon related injuries, including ruptures, can be traced to the use of Levaquin.
The pain and suffering associated with such tendon problems and ruptures can be debilitating and severe.The attorneys at Saunders & Walker can provide you and your family with a free case evaluation in preparation for a individual lawsuit or class action lawsuit.
Levaquin belongs to the same family of antibiotics as ciproflaxin (commonly known as Cipro). According to the Centers for Disease Control and Prevention, quinolones are antimicrobial agents used to treat a wide variety of infections. As an antimicrobial agent, Levaquin is a powerful drug that induces cell death thus leading to weakened tendons that may rupture. The possibilities for side effects like tendon injury and rupture are significantly increased for those who are over 60 years old or those taking corticosteroids.
This is particularly true since Levaquin has been found to be more toxic than Cipro or any number of other antibiotics. Because of the dearth of published scientific data concerning the dangerous adverse consequences of Levaquin, many doctors have prescribed Levaquin to patients who could have otherwise been prescribed a less toxic but still effective antibiotic.