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Cluster Headache Help and Support >> Medications,  Treatments,  Therapies >> If these antibiotics have been taken - FDA warning
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Message started by Kevin_M on Aug 16th, 2008 at 8:09am

Title: If these antibiotics have been taken - FDA warning
Post by Kevin_M on Aug 16th, 2008 at 8:09am
If you've taken these antibiotics and have had tendon or joint pain but thought maybe I'm just getting old, have a look, tendon ruptures have occurred.


A few years ago consumer groups reviewed the drugs.


Quote:
"The numbers are startling. Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, and switched to other antibiotics," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "The FDA must act and require black box warnings and patient information guides."

Public Citizen's review of the FDA's adverse event database shows 262 reported cases of tendon ruptures, 258 cases of tendonitis and 274 cases of other tendon disorders between November 1997 and Dec. 31, 2005, associated with the fluoroquinolone antibiotics, with 175 of those occurring since the beginning of 2003.

Sixty-one percent of the ruptures were associated with Levaquin, which has accounted for 45 percent of all fluoroquinolone prescriptions in the past four years, while 23 percent of the ruptures were associated with Cipro.

One theory is that fluoroquinolones are toxic to tendon fibers and may decrease blood supply in tendons that already have a limited blood supply.

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And sued the FDA to require their most urgent warning.


Quote:
Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing extensive surgery.

The Food and Drug Administration ordered makers of fluoroquinolone drugs -- a potent class of antibacterials -- to add a prominent "black box'' warning to their products and develop new literature for patients emphasizing the risks.

The FDA's action came after the consumer group Public Citizen petitioned -- and later sued -- the agency for such warnings. Regulators took too long to act, complained Sidney Wolfe, head of the consumer group's health section. Many injuries "would have been prevented if patients and doctors had known a pain in the tendon is an early sign that leads to rupture,'' Wolfe said. Public Citizen's original petition was filed nearly two years ago.

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The FDA confirms, these are the medications.  In other countries, check for corresponding brand names.


Quote:
The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs.

Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy.

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin

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Title: Re: If these antibiotics have been taken - FDA warning
Post by Brew on Aug 16th, 2008 at 8:44am
Did this happen to you, Kev?

My bride recently came off a course of Cipro (both IV and tablet), and I can remember at least one hospital nurse and her doctor warning her about this potentially nasty and painful side-effect.

Title: Re: If these antibiotics have been taken - FDA warning
Post by Kevin_M on Aug 16th, 2008 at 9:22am
I had read about this around two weeks ago but didn't think much of it.  I had taken Cipro four times for short periods and have had a lot of joint and tendon pain but have attributed it to a very active job with a fair amount of physical requirements.  I'm not young but have mentioned to my doctor twice about tendon and joint pain.  The conversation got off track to his vacation in Traverse City, our cherry festival town.  The growers are getting a high demand for cherry extract for joint pain and arthritis.  

Anyway...

I got this e-mail yesterday from a very best friend who is ten years older than me.  The previously posted articles had said people over 60 are more affected.



Quote:
Cipro is one of the strongest antibiotics around and it did know out my respiratory infection when I took it, but three months later, I could hardly walk.  All of my joints became inflamed and I even went to the ER, I was so scared.  They asked me if I had taken anything recently and I told them that three months before this, I had taken Cipro and they told me I had a delayed bad reaction to it, which made me feel like I was becoming crippled.  The ER gave me a shot right away and a prescription for something and then I was okay.


I don't know yet what she was given at ER or the prescription but will be inquiring, offhand it is hard to remember prescription names.

Title: Re: If these antibiotics have been taken - FDA warning
Post by purpleydog on Aug 16th, 2008 at 4:19pm
Thanks for the warning, Kevin. I'm looking at another type of med that may be related (chemically), that has caused tendon problems.

It's been many years since I've taken cipro, but I'll be sure to keep these meds "on file", in case my doc should want to prescribe them. He's pretty up on things, and teaches at the U of I medical college in Peoria, so I'm sure he knows.

I find it interesting that a person may be having a reaction to a med, like this type, and doctors don't believe you. And there has to be a major reaction for them to believe it. And something like this, they still don't believe it, the medicine has been around for a long time, the medical field is correct in their thinking, and it takes a lawsuit, and injured people, to make them look into it further.

I wonder if it doesn't also affect people who are younger too. You tend to shrug things like pain off, and it's not until you are older that you really notice it, and realize you didn't "do" anything physically to be having this problem.

Anyway, thanks again.

Title: Re: If these antibiotics have been taken - FDA warning
Post by Pixie-elf on Aug 17th, 2008 at 2:18am
Yeesh. I've been on both, allergic reaction to Cipro, and Levaquin made me lactate (I have the weirdest reactions to medicines) so I had to stop taking them. D: If this ever happens I'll definately keep this in mind.

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