FDA Urgent Warning on Tendon Risks

FDA calls for urgent warning on tendon risks

By RICARDO ALONSO-ZALDIVAR, Associated Press Writer

Tue Jul 8, 11:23 AM ET

WASHINGTON - Federal drug safety officials have imposed the government’s most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated.

The Food and Drug Administration on Tuesday ordered makers of flouroquinolone drugs — a potent class of antibiotics — to add a ‘black box‘ warning to their products, which include Cipro, Levaquin, Floxin and other medications.

Patients should immediately stop taking the medications if they develop any tendon pain, swelling or inflammation.

15 Responses to “FDA Urgent Warning on Tendon Risks”

  1. The thing I can’t seem to figure out is whether this is only while taking the drug, for a specific time afterwards, or once you have taken the drug, the damage is done. None of these articles mention that.

  2. Jim,

    You piqued my interest. This is from the FDA site:

    “Tendon rupture can occur during or after completion of fluoroquinolone use; cases occurring up to several months after completion of therapy have been reported.”

    http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm

    And this is from a longer AP story:

    “FDA officials said they had received several hundred reports of tendon ruptures, but would not cite a specific number. Sidney Wolfe, of Public Citizen, said the number was 407 at the end of 2007, with another 341 reports of tendinitis.”

  3. Wow, I just saw this too. I have taken ALL of the drugs listed (except one) over the last four years to counter recurrent kindey infections. I have had more antibiotics in my system in the last four years than I have had total in the rest of my life. If ever there was a candidate for this to happen to…

    I have to read more about this.

    Wow.

  4. That is quite frightening.

    It is not a drug I have heard of, so I don’t think I have every had it, but I will certainly check any antibiotic in future and check it out thoroughly.

    Great bit of research
    Annie

  5. On the same theme of drug interactions I noticed in a web search the other day that statins (cholesterol related drugs like lypitor and crestor) show up with tendon related side effects and occasional rupture. I wonder how many of us are taking these ? I was prescribed crestor 8 months prior to my atr incident. Any of you guys on these drugs also ?

    P.

  6. From Reuters:

    The estimated risk of tendon ruptures is about three to four times higher with fluoroquinolones, said Dr. Renata Albrecht, head of the FDA’s division of special pathogen and transplant products. The rate in the general population is about 1 in 100,000, Albrecht said.

    Most cases involve the Achilles tendon, which attaches the calf muscle to the heel. Less frequent ruptures affected tendons in the shoulders, biceps, hands and elsewhere

  7. Hey, I took Levaquin a week AFTER my achilles surgery for a UTI. It was given to me at the ER. I had developed a fever and had called my achilles surgeon and he wanted me to go to the ER we thought maybe Ihad an infection. It worried me because I thought it would affect the healing process and I’m wondering now if its causing the scar tissue tearing? I dunno, who knows anymore about this stuff.

    Cathy

  8. This is insane. In the 3 months before my injury I took 2 courses of Cipro generic meds to combat an ear infection. This warning has come a bit late I guess!

  9. Thanks for doing my homework Dave.
    -Jim

  10. [...] use and tendon ruptures has come up numerous times in the last few months.  Most recently, as daveleft pointed out, the FDA has ordered makers of fluoroquinolone drugs — a potent class of antibiotics — to add a [...]

  11. Wow - I have taken about 4 courses of Levaquin over the last 5-6 years, for recurrent sinus infections. This is very interesting . . . I think I will avoid it in the future!
    Jen

  12. Here’s some more info:

    http://achillesblog.com/posts-worth-reading/drugs-that-can-increase-your-risk-of-atr/

  13. wow. i have never heard of this before, but like so many others, i have taken these drugs many times over the last 3 years for recurrent sinus infections. in fact, i was on levaquin for 4 months about 2 years ago because it was that or sinus surgery at that point. oh dear. really good to know for the future.

  14. I took part of a course of one of the antibiotics in question 2 months prior to the rupture. Sad thing is it turned out I didn’t even have an infection (I had Burstis, which is not treated with antibiotoics) and was misdiagnosed - by two separate doctors- hence the reason normal antibiotics weren’t working.

    I’m 6 months post surgery today and only just read this blog, and suddenly some reasons for the rupture are becoming clear.

    Does anyone know if there is any evidence of long term tendon damage caused by the flouroquinolones? Or does the tendon recover a few months after taking the antibiotic?

    I’m scared now.

  15. Hi running doc. Thanks for the blog I too was at the Chicago R R and had a relaly great time. I am going to take full advantage of the blog and ask a couple of questions related to my run.1) I am training for the Chicago Full Marathon and a BQ (3:20). Based on my training up to this point I set a goal of 1:38-1:40 for the R R. After about mile 10 I was unable to hold this pace and finished at 1:43. I can’t think of anything I did differently (a little sleep deprived perhaps but not significant diet, prerace prep, shoes all the same). I know there are many reasons why runners have bad days what are some that I may not be considering?2) I heard two peices of advice at the expo from other runners that you may be able to comment on first, someone told me a more efficiant breathing technique is in through the nose out through the mouth seems odd to me; and second landing on the ball of the foot will result in a faster more efficiant stride. Please seperate fact from ficton here.

    [WORDPRESS HASHCASH] The poster sent us ‘0 which is not a hashcash value.

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