Fluoroquinolones Receive Black Box Label by Fda

The fluroquinolones drug family are antibiotics that treat an array of bacterial infections depending on what type of drug (Cipro, Levaquin, etc.). However, all the drugs of this class have been associated recently with a serious and irreversible risk of tendon rupture among patients, thus resulting in a black box labeling by the U.S. Food and Drug Administration (FDA).

By: Katie Kelley
(c) 2008 Katie Kelley

In America, there are thousands of antibiotics being used, created or tested. The U.S. Food and Drug Administration (FDA) is responsible for ensuring these drugs are safe for patients and receive the appropriate warning labels for doctors. Recently, the fluoroquinolone group of antibiotics were given the most severe warning by the FDA -- the black box labeling.

The drug types within the fluoroquinolone family include:

* Levaquin (levofloxacin).

* Factive (gemifloxacin mesylate).

* Avelox (moxifloxacin HCL).

*Cipro XR and Proquin XR (ciprofloxacin extended release).

*Noroxin (norfloxacin).

*Floxin (ofloxacin).

*Cipro (ciprofloaxacin).

With the new labeling, the drugs will now carry a black box warning label, considered the strongest label given by the FDA. Researchers continue to find evidence linking the fluoroquinolone antibiotics to the tendon rupture or Achilles tendonitis, but a recall of the drugs has yet to occur.

What is Achilles Tendonitis?

Achilles tendonitis is the inflammation or irritation of the Achilles tendon. Individuals who have taken any of the fluoroquinolone prescription drugs, especially the more common Cipro, may be at risk for Achilles tendonitis, which often results in the tendon rupture or tear. If Achilles tendonitis does lead to a tendon/muscle tear, the chances for surgically operating to treat the tendon rupture are high. Cipro was associated with Achilles tendon rupture in a study published in Clinical Rheumatology in February 2004.

Because scientists and researchers are finding an increased risk of Cipro-related tendon rupture, it is important for any individual who has previously taken Cipro - even if it was anywhere from 1 week ago to 6 months, 2 years or prior - that the patient speak with a physician, especially if they are experiencing pain or swelling of their muscles.

Uses for Cipro

Cipro, is manufactured from Bayer A.G., and is one of the more commonly prescribed fluoroquinolone prescription drugs. It is used to fight the following bacterial infections as well as other bacterial condensations:

* Enterobacteriaceae.

* Vibrio.

* Haemophilus influenza.

* Neisseria gonorrhoeae.

* Neisseria meningitidus.

* Moraxella catarrhalis.

* Escherichia coli (E. coli).

* Mycobacterium intracellulare.

Cipro has also been approved to treat the symptoms of an anthrax attack.

Cipro Side Effects

In addition to the severe tendon rupture risk associated with taking Cipro, the prescription antibiotic has also been linked to other discomforting and painful side effects. According to Medline Plus, a service of the U.S. National Library of Medicine and the National Institutes of Health, some of the additional side effects include:

* nausea.

* vomiting.

* stomach pain.

* vaginal itching/discharge.

* paranoia.

* nightmares or abnormal dreams.

* anxiety.

* indigestion.

* diarrhea.

* headache.

* nervousness.

* agitation.

While the previous side effects may seem as if there are average or normal when taking a prescription drug, Medline also included a list of several side effects that will require a patient to discontinue their use of Cipro immediately, as their health may be at risk. Additionally, an array of grave side effects and risks include:

* rash, blisters, hives or itching.

* tingling or swelling of limbs, face, neck, throat, lips, eyes or lower legs.

* loss of muscle strength.

* numbness.

* hoarseness.

* fainting.

* suicidal thoughts/tendencies.

* depression.

* hallucinations.

* seizures.

* confusion

* burning sensation, weakness of body.

* fever.

* joint or muscle pain.

* jaundice.

* double vision, dizziness.

* loss of energy, tiredness.

* easy bruising or bleeding of body.

* loss of appetite.

Preventing Harmful Cipro Risks

Individuals who have been adversely affected by the potentially harmful Cipro side effects are advised to contact an experienced pharmaceutical lawyer, as a Cipro attorney will be able to provide legal consultation and individual assistance for a lawsuit. Cipro risks may be fatal or long lasting. In which case, an individual affected by the prescription drugms dangers should develop a pharmaceutical lawsuit to be reimbursed for the damages caused.

Visit one of the Flouroquinolone family drug sites, such as Cipro, at http://cipro.legalview.com or Levqauin at http://levaquin.legalview.com/. Also use the LegalView homepage to find other controversial pharmaceutical risks such as the Avandia side effects or the Ketek risks.









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