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FDA Advises Restricting Fluoroquinolone Use Due to Serious Side Effects

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Washington, DC: The US Food and Drug Administration (FDA), has issued an advisory warning that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.

The warning is based on an FDA safety review which showed that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, the FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information.

Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).

The FDA has stated that it will continue to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.



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Reader Comments

Posted by

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I took Levaquin for asthma, bronchitis, and pneumonia in March of this year. My doctor gave this to me because other meds did not work. I developed double vision in my one eye from this medication. It was awful and very frustrating. My doctor only told me to watch out for achilis tendon pain, nothing about my eyes. There are over 300 complaints from people online who got double vision after taking this drug. I also have developed back problems, which I never had before that. Why do they leave a drug on the market that is that dangerous and strong and can do this damage to someone? Thank God, my double vision went away at 10-1/2 weeks. I invented ways to be able to drive and conduct my daily life during that time, but it wasn't easy. I couldn't drive up to take care of my grandchildren, as my son didn't think I could see good enough to do it. I had to drive my husband around as always and do all my usual daily errands, etc. He has a prosthetic leg and fell and broke his other leg last year. I am now afraid that it may come back again one day, because my nerves in my eye may be a weak spot now.

Posted by

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I was prescribed Levaquin August 2010. Soon after I lost 50 pounds of muscle, and have never been able to get it back. I am in constant pain, 24/7. This drug has ruined my life. I have nerve pain all over. My muscles & nerves just don't work right, like their "out of sync". I have constant pain in my muscles & tendons, all over. I can't sleep due to the pain. Ànd I am in a constant state of exhaustion. I am also "on- the- edge" & "pissed-off" all of the time due to the constant pain & exhaustion.

Posted by

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I took Levofloxacin in Feb. 2015. I have wide-spread neuropathy, tondonitis in several areas, joint pain, muscle weakness. The symptoms are kept somewhat "at bay" but only with 2 other prescriptions and a handful of vitamins and minerals. Without use of these 2 prescriptions, I wouldn't be able to walk. Before Levofloxacin- I worked out at least 3 times per week. I was strong. This drug is disabling... and this condition may be irreversible.

Posted by

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I took leviquin and have neuropathy, stomach and tendinitis and seeking to join class action.

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