Levaquin Linked to Tendon Ruptures and Stevens Johnson Syndrome (SJS)

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On July 8, 2008, the U.S. Food and Drug Administration (FDA) ordered black box warnings to be added to Levaquin because of the increased risk of tendon rupture, particularly with the Achilles tendon.

Click Here to read entire FDA release on Levaquin

A black box warning is the strongest warning the FDA will give a drug; it means that medical studies have indicated Levaquin has a significant risk of adverse side effects including death. In addition to the warning, a Medication Guide must also be given to people who are prescribed Levaquin to learn of possible side effects. The black box warning came only after Public Citizen, a consumer advocacy organization, placed continued pressure on the FDA.

Levaquin or Levofloxacin is a prescription drug and is used to treat bacterial infections in lungs, skin, urinary tract and sinuses. It is also prescribed to treat bronchitis and pneumonia. It does not treat any type of viral infections. Levaquin works by killing bacteria or limiting its growth, to give the body time to fight the bacterial infection. Levaquin can be taken orally or through an injection. The FDA approved Levaquin in 1996.

Two rare but very serious reported side effects of Levaquin are Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (also commonly known as Lyle’s Syndrome). Stevens Johnson Syndrome (SJS) can cause numerous areas of the skin to become detached, vision loss and blindness. SJS can also cause lesions to develop in the mucous membranes. Infections caused by the damage to the skin or scarring of major organ systems can lead to severe debilitation of the patient or death.

In 1996, Public Citizen petitioned the FDA for warnings on Levaquin labels. Although the FDA granted the petition, the warning was not really visible on the labels and was therefore, inadequate. In 2006, Public Citizen again petitioned the FDA about the tendon ruptures and other dangers associated with Levaquin. This time, the Illinois Attorney General’s Office was also a party to the Levaquin petition. In this petition, Public Citizen asked the FDA for a black box warning because of the risk of tendon rupture.

During the ten-year period between the two petitions, nearly 1,000 tendon ruptures, tendonitis and tendon disorders were reported to the FDA. Levaquin has caused over 60% of those injuries, with the most common injury being the rupture of the Achilles tendon.

Other serious Levaquin side effects include:

• Tendon Ruptures (in shoulder, biceps, hand and thumb)
• Stevens Johnson Syndrome
• Rotator Cuff Ruptures
• Seizures or Trembling
• Renal Failure (kidneys)
• Rhabdomyolysis (musculo-skeletal disorder)
• Toxic Epidermal Necrolysis (TEN) (type of skin condition)
• Jaundice
• Swelling and Pain (in legs and muscles)
• Hallucinations
• Heart Rhythm Changes
• Peripheral Neuropathy (damage to nervous system which transmits information from brain and spinal cord to the rest of the body)
• Death

Tendon ruptures and tendonitis are the most frequent side effects of Levaquin and can occur at any time.

Ruptures have been reported while patients were taking the drug and months after they had stopped taking Levaquin. It is believed the active ingredients in the drugs may be toxic to tendon fibers and decrease blood supply in the tendons. There is also an increased risk of serious side effects from Levaquin for three specific groups of people. According to the FDA, tendon problems are higher in people who are over the age of 60, patients who take steroids and patients have undergone organ transplants.

Levaquin is part of a larger group of drugs called fluroquinolones. Although Levaquin is the drug with the more severe side effects, other fluroquinolones drugs have been shown to cause tendon ruptures. The FDA’s black box warning applies to all fluroquinolone drugs.

You should also be aware of potential tendon ruptures or tendonitis if you have taken any of these drugs:

• Factive
• Penetrex
• Tequin
• Maxaquin
• Avelox
• Noroxin
• Floxin
• Cipro

PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING USE OF LEVAQUIN OR ANY OTHER PRESCRIPTION DRUGS.

Contact the Law Offices of d'Oliveria & Associates, P.C.

If you believe that you or a loved one has suffered serious injury or death as a result of Levaquin, you may want to speak with a personal injury attorney regarding a potential lawsuit. An injury lawyer familiar with new developments in the investigation may be able to help you make important personal and legal decisions.

Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.