Floxin symptoms and conditions

Saw this story on CNN today. Guess we aren't all tinfoil-hat wearing nutcases after all.

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FDA orders 'black box' label on some antibiotics

The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendinitis.
Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

"The new language will strengthen the existing warnings," said Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products.

The FDA is requiring the label warnings and a medication guide for fluoroquinolone drugs, which include Cipro, Levaquin, Avelox, Noroxin and Floxin.

The consumer group Public Citizen asked the FDA in August 2006 to put the "black box" warning on Cipro and other fluoroquinolones, and also to warn doctors. Earlier this year, Public Citizen filed a lawsuit to force the FDA to take those actions.

When asked about the lawsuit and why it took so long to add the label warning, Cox stressed that the FDA included warning information with the drugs from 2001 until 2004, and updated the information last year.

"There has been ongoing work to update the labeling of the fluoroquinolone drug products," Cox said. "We have been working on this issue and making progress over time."

The companies that make the fluoroquinolone drugs will be required to submit label safety changes and the medication guide within 30 days of receiving the notification from the FDA or provide a reason why they do not believe such labeling changes are necessary, Cox said.

The fluoroquinolones drugs can increase the risk of tendinitis and tendon rupture -- which is about 1 in 100,000 -- by three to four times, according to the FDA's Dr. Renata Albrecht.

"This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy," the FDA said in a statement.

Albrecht said that sometimes patients have no symptoms before they experience a rupture in their tendon -- commonly their Achilles tendon.

"Sometimes it's been reported on the first day of taking a fluoroquinolone ... a sudden snap or popping sound that is tendon rupture with no preceding warning," she said.

Normally, she added, that patients experience some pain or inflammation "a week or two before the patient will rupture."

The FDA would only say that it has received "hundreds" of reports of tendon problems linked to fluoroquinolones, without being more specific, citing the ongoing lawsuit. But Cox said "the FDA continues to receive a considerable number of reports on tendon adverse effects."

Patients should stop taking fluoroquinolone antibiotics at the first sign of tendon pain, avoid exercise and contact their doctor, the FDA said.

Cox said the FDA would not require companies to send letters to doctors alerting them about the connection between tendon problems and the antibiotics.

"It is possible under REMS to ask for a letter ," Cox said. "Certainly for sponsors that would choose to go forward with a letter, we'll be happy to work with them."

I'm on day 12 of a 14 day course of Avelox.

I usually have problems with antibiotics that are of the Quinilone or Floxin family so I was worried about taking this medication.

I've hung in there so far. I seem to have had a middle ear infection caused by my sinusitis problems.

I have noticed some nausea, increased urination and tiredness. I haven't had any joint pain; maybe a bit of stiffness.

I never had antibiotic problems till the newer forms of the old antibiotics became popular. I know I'm allergic to sulfa drugs but never had problems with any other medications till recently.

Now I can't decide if it's worth the pain and misery to take the antibiotics that are now available.

I'm a 45 yr-old male in pretty good health. Start Cipro for prostatitis, 500mg x2 / day. Eight days into therapy, starting experiencing tinnitus, tingling in hands & feet, and anxiety++. On day 9, actually experienced a significant facial 'tic'. Stopped drug on day 9; anxiety faded out 95% in less than 2 days, tingling has abated about 1/3 after 4 days, but still remains very noticable (of course, now I'm focused on it). Tinnitus remains at the same level. Have taken Floxin & Levequin several in the past with no adverse effects.

Just an FYI to BettyPaint and any one else on the board that doesn't know this. Ancef is not in the same family as Levaquin. Levaquin is a flouroquinolone. Ancef is not a flouroquinolone or a quinolone. Ancef is a cephalosporin. Cephalaosporins are another class of antibiotics. The flouroquinolones (Levaquin, Cipro, Floxin, etc) are what is causing everyone's problems on this board. I took 1 500 MG of Levaquin 5 months ago and I still suffer with tendon pain in my achilles and plantar fascia. Both feet! It's unbelievable. Levaquin has horrific side effects associated with it.

Nikki,

This is in addition to the last post I made to you. You should stop taking the Levaquin and ask your doctor for another antibiotic. Just make sure that it is not a flouroquinolone or a quinolone (Cipro, Avelox, Floxin, etc). This family of antibiotics will cause all of the same pains and then some. Do read the other posts and visit the websites mentioned. You'll be in shock from what you learn about these antibiotics. Be prepared for your doctor to have no knowledge of these side effects. Your doctor will probably tell you not to read stuff off of the internet and dismiss your claim that your pains are drug related. Just remember that it is your body and your health. Insist on a different antibiotic.

I'm addressing this to the 52 year old healthy woman. I believe whole heartedly that the pain that you are suffering is an ADR (Adverse Drug Reaction) to the Levaquin. You must stop taking it and tell your doctor that you insist that he/she prescribe another antibiotic that is not part of the Flouroquinolone (Cipro, Floxin, etc) family. When you stop taking the drug the pain should subside, but it can linger for weeks or months after you stop taking it. Also, do not take any form of Ibruprophen (Advil, Motrin, etc) with the Levaquin. I know that I read somewhere that the two should not be taken together. Also, no steriods should be taken with Levaquin either. I am about for weeks out from my Levaquin experience and I also suffered from severe joint pain in my arms, wrists and hands down to every finger. My pain has gotten better, but every day when I wake up one or two of those joints still hurt. It comes and it goes. Trust me, everyone who reads this site or posts to this site believes you when you say it's the Levaquin. My doctor knew it was the Levaquin that was causing the pain. I didn't have to convince him and you shouldn't have to convince your doctor either. Make that doctor change that prescription to another antibiotic to treat your original problem. Take the suggestion from the other guest on this site and visit those websites to get yourself educated about this drug. You may also find comfort in knowing that you are not alone. Trust me, you are not alone.

I took Floxin for about a week FIVE YEARS ago. I still feel like my knees are going to fall off and the pain in my neck and shoulders is horrible. It does not get better!!! Im only 31 but my body hurts like im 91. Even my 60 year old neighbor doesnt hurt like I do. HOW can they STILL be perscribing this stuff???????????????