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Fluoroquinolone Antibiotics Receive Updated FDA Warnings

by Madhumathi Palaniappan on  July 28, 2016 at 4:50 PM Drug News   - G J E 4
The United States Food and Drug Administration has approved safety labeling changes for a specific class of antibiotics called Fluoroquinolones. These antibiotic drugs are capable of causing serious side effects that may result in disability of muscles, joints, tendons and central nervous system.
Fluoroquinolone Antibiotics Receive Updated FDA Warnings
Fluoroquinolone Antibiotics Receive Updated FDA Warnings
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Fluoroquinolone antibiotics are used to kill or inhibit the growth of bacteria. They usually fight against bacterial infections. Drugs like levofloxacin, ciprofloxacin, moxifloxacin, ofloxacin and gemifloxacin are approved by the FDA for the treatment of bacterial infections.

‘Fluoroquinolone antibiotics receive updated FDA warnings due to side effects that result in permanent disability of muscles, tendons and joints.’
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However, the FDA safety review has listed oral and injectable fluoroquinolones being associated with permanent side effects resulting in disability which is linked to muscles, nerves, tendons and joints. These side effects may occur immediately or after few weeks of the treatment with antibiotics.

The FDA has thus reserved the use of fluoroquinolone antibiotics only for conditions like anthrax, bacterial pneumonia which has no alternative treatment options. These drugs are generally used for conditions where the benefits of the drug outweigh the risk factors and adverse effects.

The labeling changes include categories like boxed warnings, contraindications, warnings and precautions, adverse reactions and patient prescription information or medication guide for the safe use of medicines.

The first boxed warning for fluoroquinolones was given in 2008 for an increased risk of tendonitis and tendon rupture followed by another in 2011 due to the worsening symptoms in myasthenia gravis patients.

In 2015, the FDA advisory committee discussed on the serious side effects and benefits of fluoroquinolone antibiotics for uncomplicated infections like bacterial sinusitis, bronchitis and urinary tract infections and concluded that the risks of permanent impairement outweighed the benefits of the drug in these conditions.

Hence the FDA has recently warned the use of fluoroquinolone antibiotics for these conditions. The new safety information will be updated in the drug labels.



Source: Medindia
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