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Fluoroquinolones Receive Black Box Label By FDA

Jul 29, 2008
A group of antibacterial prescription drugs has recently been subject to a warning label increase by the U.S. Food and Drug Administration (FDA). The fluoroquinolone group consists of several various types of antibiotics that treat an array of bacterial infections.

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. While no recall has been implemented, the dangers are becoming more apparent among the most common risk for the fluoroquinolone drugs which is Achilles tendonitis/tendon rupture.

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. These more severe side effects are as follows:

* 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. The risks associated with Cipro are clearly dangerous and some may be life-long lasting side effects. In which case, an individual affected by the prescription drug's dangers should develop a pharmaceutical lawsuit to be reimbursed for the damages caused.
About the Author
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.
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