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FDA Issued Black Box Warning for Levaquin and Cipro
On July 8, 2008, the U.S. Food and Drug Administration
(FDA) ordered black box warnings to be added to Levaquin and
Cipro because of the increased risk of tendinitis and tendon
rupture, particularly with the Achilles tendon. Read
More.
A black box warning is the strongest warning the FDA will give
a drug; it means that medical studies have indicated Levaquin
and Cipro 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 Cipro and 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 or Cipro, 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.
Cipro, Ciproxin or Ciprofloxacin is a prescribed antibiotic and used to treat
lower respiratory infections, urinary tract infections, bone infections, joint
infections and sexually transmitted diseases (STDs). It is also prescribed for
bronchial infections, typhoid fever, prostate gland infections and tuberculosis.
Cipro was used to treat victims of anthrax attacks and became increasingly popular
after September 11th 2001. It does not treat viral infections. Cipro works by
stopping the production of essential proteins, which are needed for the bacteria
to survive. This helps the body fight bacterial infections. The FDA approved
Cipro in 1987.
In 1996, Public Citizen petitioned the FDA for warnings on Levaquin and Cipro
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
and Cipro (http://www.citizen.org/pressroom/release.cfm?ID=2262). This time,
the Illinois Attorney General’s Office was also a party to the Levaquin/Cipro
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 caused over 60% of those injuries while Cipro
accounted for 23%, 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)
- Tendonitis (inflammation of the tendon)
- 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 Cipro and can occur at
any time. Ruptures have been reported while
patients
were taking the drug and months after they had stopped taking Levaquin and
Cipro. 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 and Cipro 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 and Cipro are part of a larger group of drugs called fluroquinolones.
Although Levaquin and Cipro are the drugs 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
PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING
USE OF LEVAQUIN OR CIPRO.
If you believe that you or a loved one has suffered serious
injury or death as a result of Levaquin or Cipro, you may
want to speak with an
attorney
regarding a potential lawsuit. A lawyer familiar with new developments
in the investigation
of Levaquin and Cipro may be able to help you make important personal
and legal decisions.
Please CLICK
HERE for a free consultation.
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