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Levaquin Linked to Tendon Ruptures and Stevens Johnson Syndrome
(SJS)
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.
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. If you or a loved one suffered as a result
of Levaquin , CLICK
HERE for a free legal case evaluation.
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
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 MEDICATION.
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 an
attorney
regarding a potential lawsuit. A lawyer familiar with new developments
in the investigation
may be able to help you make important personal
and legal decisions.
Please CLICK
HERE for a free consultation.
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