Overview of Levaquin
Including Tendon Injuries & Litigation

By Herman I. Kalfen

Kalfen Law Corporation

What is Levaquin?

Levaquin (levofloxacin)is a 3rd-generation fluoroquinolone antibiotic, manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson. Quinolone antibiotics include: ciprofloxacin (Cipro, Cipro XR, Proquin XR), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin). 

Levaquin as an antibiotic to treat bacterial infections in many different parts of the body. Levaquin and quinolones are antibiotics, prescribed in adults to treat lung, sinus, skin, prostate and urinary tract infections caused bacteria.  Levaquin and quinolones do not work for viral infections such as a common cold or the flu.

FDA warns that Levaquin linked to Tendon Injury

While patients taking Levaquin have reported a variety of minor side-effects, common with any medication, the most serious Levaquin side effect reported has been an increased risk of Achilles tendonitis among current and former patients. Several studies published in accredited medical journals have cited case studies in which individuals who have taken Levaquin have been adversely affected by levofloxacin-induced tendonopathy and tendon rupture.

FDA estimates that spontaneous ruptures occur in about one in 100,000 people, and that quinolone use appears to triple or quadruple the risk of injury.  The risk of quinolone tendon injury is further increased in patients over 60 years of age; who are kidney, heart, and lung transplant recipients; or receiving concomitant steroid therapy.

Most of the tendinitis and tendon ruptures have involved the Achilles tendon, the body’s strongest tendon, which passes behind the ankle. However, FDA has also received reports of tendinitis and ruptures in the shoulder and hand, biceps, and thumbs, according to the FDA.

The consumer group Public Citizen sued the FDA to require the agency to add box warnings to all fluoroquinolone antibiotics. A Boxed Warning is the strongest warning that the FDA can require a prescription drug to include in its labeling.

As of July 8, 2008, as a result of litigation and complaints regarding tendonitis and ruptured tendons associated with Levaquin and quinolone antibiotic use, the FDA has required labeling for Levaquin and other quinolone antibiotics to include a “Boxed Warning.”  Pharmaceutical companies are also required to develop a Medication Guide for patients regarding possible quinolone side effects.  This is to alert doctors and patients of the increased risk of developing tendinitis and tendon rupture associated with systemic use of these antibiotics.

Drug Maker Failed to Provide Adequate Warnings of Risks lf Levaquin

Ortho-McNeil, a subsidiary of Johnson & Johnson which manufactures the antibiotic, has failed to provide adequate warnings about Levaquin side effects.

Ortho-McNeil failed to warn of an increased risk of

1. Tendon Rupture
2. Tendon Damage
3. Tendonitis

If additional information had been provided earlier to doctors and patients, many individuals may have been able to prevent a tendon rupture or permanent damage by seeking medical treatment at the first sign of pain or inflammation

If you're aware of a serious adverse reaction to Levaquin®, the FDA encourages you to make a MedWatch report or call 1-800-FDA-1088.

Additional Risks of Levaquin Side Effects

In addition to the risk of tendon rupture among patients, Levaquin may cause other discomforting side effects including sensitivity to sunlight, which is caused through levofloxacin mixing improperly with other medications like antacids containing aluminum, calcium or magnesium; abdominal tenderness or stomach cramping; blisters; diarrhea; confusion; agitation; fever; trembling; sensation of the skin burning; and psychosis and hallucinations. The Mayo Clinic recommends immediate medical attention if any of the above side effects occur in patients.

Individuals who also have preexisting medical conditions are also advised to avoid the medication because of serious complications that can occur. For example, studies have found that individuals suffering from brain or spinal cord disease taking the drug may have an increase of seizures, while diabetic patients taking Levaquin may find uncontrollable changes in blood sugar levels. Also, the effects of kidney disease are increased among patients with kidney-related issues because of the slow removal of levofloxacin from the body, according to the Mayo Clinic.

Selected Studies of Levaquin Risks

The Journal of Antimicrobial Chemotherapy published a study conducted by the Department of Microbiology at The University Hospital Lewisham, of several patients being treated with Levaquin, although all were elderly in age, the report found that the link to “Achilles tendonitis and rupture may be more common adverse effects of levofloxacin than previously thought.” Despite the fact that this risk has surfaced among adult patients, the FDA continued to approve the drug for use in children under the age or 18. Some researchers believe that the use of the drug for children should be further studied prior to approval, but the FDA has done nothing to block or slow the drug’s availability on the market.

Another study reflecting the same sentiment involving risks of tendonitis was published in The Journal of the American Board of Family Medicine. Here medical researchers noted that there has been a rise in tendon rupture incidence since the 1980s when the first cases of the effects of fluoroquinolones on tendons were documented. The study concluded that as more individuals are prescribed levofloxacin, the risk of tendon rupture would continue to rise as well.

Additionally, the study noted that individuals who are showing signs of joint swelling and tenderness that had previously been prescribed the drug, as far back as six months or more, may be at risk for tendon rupture and should seek medical help right away. The study noted that the risks of tendonitis are severe among patients of levofloxacins and the outcome can range from minor discomfort to death. The only way to reduce the morbidity rate of patients associated with the drug-induced tendonitis or rupture is with prevention of prescribing the drug or intervention of patients taking the drug.

Additional Risks to Children

While most of the previous studies were conducted on elderly patients, the Mayo Clinic released an article on the potential risks of prescribing Levaquin to patients younger than 18 years of age. According to the article, published in mid-2007, the use of levofloxacins for children can potentially disrupt bone development. This information derives from testing of the medication on young animals that were found to have developmental issues after use of the drug. The Mayo Clinic expressed caution when prescribing the drug to young individuals and extreme care must be taken to ensure the proper dosage is prescribed and consumed.

What are Tendons

A tendon is a tough band of tissue that connects your muscles to your bones. Tendons help move skeletal bones by transmitting a force on the bones as the muscle contracts. A ruptured tendon is a serious injury resulting in excruciating pain and disability if left untreated.  Tendinitis is an inflammation or irritation of a tendon, causing substantial tenderness and pain.

Some Symptoms of Tendon Rupture

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

What To Do if Levaquin Tendon Rupture Occurs – See a Doctor Immediately

Patients who have taken Levaquin and suffer from tendon rupture or who have signs of tendon swelling or pain should seek medical attention immediately, as the severity of the incidence may increase if medical assistance is not sought.

Individuals may be prescribed the use of a cane, splinting, crutches or casting to manage the tendonitis, according to Michael Rudzinski, PA-C, RPh, a practicing physicians assist in orthopedics and pain management in the VA Medical Center in New York. However, if the condition is severe, surgery may be required to repair torn tendons.

What To Do if Levaquin Tendon Rupture Occurs – See a Lawyer

After you get medical attention, you should contact a lawyer immediately.  Every day may matter as Statutes of Limitations may forever bar your claim if you do not bring it on time.

Please be ready to provide your lawyer information regarding:

1. When and how long you took Levaquin®, as well as the dosage; and,
2. Whether you took Levaquin® regularly; and,
3. What type of Levaquin® -related injury you suffered; and,
4. When the injury occurred.

© Herman I. Kalfen 9.17.09  (Disclaimer - No legal advice given herein)