Monday, June 16, 2008

Levaquin Approved for Children Despite the Potential Link to Severe Tendon Ruptures Among Patients

Levaquin Approved for Children Despite the Potential Link to Severe Tendon Ruptures Among Patients
The U.S. Food and Drug Administration (FDA) recently
approved an antibiotic known as Levaquin (levofloxacin),
part of the fluoroquinolone antibiotic group of drugs used
to fight infections, for use by children even though the
drug's potential link to severe side effects remains
uncertain.

Potential Serious Levaquin Side Effects

Levaquin, from makers Ortho-McNeil, was released to the
market in 2004. The drug is used to treat a wide range of
bacterial infections including pneumonia, bronchitis, skin
infections, urinary tract and prostate infections,
Chlamydia and gonorrhea.

The FDA has also approved Levaquin for use against anthrax
inhalation for both adults and, recently, children as well.
However, several studies have been published recently the
antibiotic to severe and spontaneous Achilles tendon
rupture among patients treated with Levaquin.

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. Child
Risks of Levaquin Consumption

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.

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.

What To Do if Levaquin Tendon Rupture Occurs

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. Those with
Levaquin-induced tendonitis are also advised to contact an
experienced Levaquin attorney who can offer assistance with
developing a Levaquin lawsuit. Because the risks of the
drug have surfaced and can be considered preventable,
becoming involved with a potential Levaquin class action
lawsuit may be an option to seek monetary compensation for
pain and suffering caused.


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For more information on Levaquin, visit
http://levaquin.legalview.com/ . Learn about similar legal
and pharmaceutical issues like the Digitek digoxin
toxicity. Also, find other information on the LegalView
site such as the revamped traumatic brain injury portal at
http://brain-injury.legalview.com/ .

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