LegalView Reveals Details of the FDA Mandated Black Box Warning For Fluoroquinolone Antibiotics

July 11, 2008 - PRLog -- Denver, CO - LegalView, the number one resource for everything legal on the Internet, reported details of a recent U.S. Food and Drug Administration (FDA) mandate regarding the fluoroquinolones antibiotics family of drugs. All of the fluoroquinolones will now carry black box warning labels to ensure physicians and patients understand that the drugs have been associated with an increased risk of tendonitis and tendon rupture (http://levaquin.legalview.com).

Among the most common of the fluoroquinolone antibiotics are Levaquin, Cipro, Factive and Avelox - some of the most commonly prescribed anti-bacterial drugs. Levaquin, also known as levofloxacin, is an antibiotic that fights infections including bronchitis, pneumonia, Chlamydia, gonorrhea, skin infections, urinary tract infections, etc. It has been previously linked to Achilles tendonitis among patients who were prescribed the drug. A study released in The Journal of American Board of Family Medicine reported the Levaquin warning (http://levaquin.legalview.com) and associated risks with prescribing the drug, however, the drug was approved for the use of children as an antibiotic and potential treatment for airborne anthrax in 2008 only a few years after the report was published. According to the study, patients who had taken the drug at any time, even two years or prior, may be at an increased risk for tendonitis. And those who were elderly seemed to be at the highest risk. Individuals who have taken Levaquin are advised to contact an experienced pharmaceutical attorney to learn about the potential for developing a Levaquin lawsuit.

Cipro, known as ciprofloaxacin, is manufactured and sold by Bayer A.G. and is used to treat bacterial infections, although it is not recommended for victims of the common cold or flu. A study published in the Clinical Rheumatology December 2003 issue, noted the relationship of the drug's consumption compared to patients with Achilles' tendon rupture and reported that there may be cause for a Cipro warning that links the drug's use to the risk of tendonitis. In addition to this risk, other Cipro side effects can include seizure, difficulty breathing, hallucinations, depression, blacking out, chest pain, suicidal thoughts and numbness.

Another one of the more commonly used drugs that is part of the fluoroquinolones group is Factive. Factive, gemifloxacin mesylate, is an oral prescription drug that has also been linked to the tendon rupture as the most serious risk, although some other Factive side effects can be considered just as serious, including phototoxicity, abnormal heartbeats and central nervous system conditions. The drug was released for market in April 2003 from Oscient Pharmaceuticals with the tendonitis Factive warning printed on an informational pamphlet issued by the company, although it was not at that time marketed with a black box warning even though the risks of Achilles' tendon rupture were known among the manufacturers. Factive, similar to Cipro and Levaquin, treats lung bacterial infections for patients 18 years and older.

Finally, adult patients who have been taking Avelox (moxifloxacin HCL) for treatment of either bacterial sinusitis, bronchitis or pneumonia infections should be aware that an Avelox warning and increase of a black box labeling will also be issued per the FDA's mandate. Because Avelox is part of the fluoroquinolones antibiotic group, the Avelox side effects also consists of an increased risk for tendonitis or tendon tear/rupture.

It is important for individuals who have taken or are currently taking any of these drugs (Levaquin, Cipro, Factive and Avelox) or any of the other fluoroquinolones antibiotics be aware of this increased warning and FDA mandate, as the potential for a prescription drug lawsuit may exist, especially if a patient that previously consumed any of these drugs has suffered from Achilles tendon rupture. It is advisable for a victim to contact an experienced pharmaceutical law firm to receive legal consultation for possible fluoroquinolone-related litigation. It is also important for patients to contact their physician immediately if muscle soreness or tenderness occurs while consuming any of these anti-bacterial prescription drugs, as this may be a sign of tendon rupture.

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