Tendinitis and Tendon Rupture Lead to Black Box Warnings
InjuryBoard.com
08/19/2008- An increased risk of tendinitis and tendon rupture has lead the FDA to seek a black box warning for fluoroquinolone antimicrobial drugs. The manufacturers of the drugs must also create a medication guide for patients, regarding the possible side effects. Even after more specific warnings about tendon risks were included on the drugs' labels, the number of reports of tendon rupture did not decline. Therefore, the FDA is taking the step of requesting black box warnings. The drugs affected by this black box request include Cipro and Proquin brands ciprofloxacin, Factive brand gemifloxacin, Levaquin brand levofloxacin, Avelox brand moxifloxacin, Noroxin brand norfloxacin and Floxin brand ofloxacin. Fluoroquinolones are used to treat and prevent certain bacterial infections. These drugs are not used for viral infections, like the flu.
The risk of tendinitis and tendon rupture, while taking fluoroquinolones, is increased in patients with kidney, heart and lung transplants, those older than 60, and patients taking corticosteroid drugs. Symptoms include swelling, pain and inflammation of a tendon. In July, the FDA issued information to healthcare professionals regarding the black box warning and the possible side effects of fluoroquinolones.
For more information on fluoroquinolones please visit http://www.ennislaw.com/fluoroquinolones.html
I would hope that the legal community would not stop at litigation involving just the tendon injuries. This class is associated with far more serious and permanent damage than just that. Having been abandoned by the medical community as well as the media, it appears that the only ones who give a damn about our serious and crippling medical problems appear to be attorneys. Perhaps if enough lawsuits are filed seeking justice for those whose lives have been destroyed perhaps someone will sit up and take notice.
Tendon rupture is the least of the patient's concerns. This class is associated with irreversible peripheral neuropathy, fatal liver and kidney damage, fatal hypo and hyperglycemia, SJS and TEN, toxic psychosis, spontaneous ruptures not only of the tendons but also muscles, ligaments and cartilage, the list of serious adrs is boundless. More than half of the drugs found in this class have been removed from clinical practice due to severe and even fatal adverse reactions.
Within the NDA (new drug application) for levofloxacin we find clinical studies that revealed an adr rate in excess of 40% (one or more reactions) and a number of listed fatalities. We find these same numbers with all the NDAs for this class. This tendon issue we are now discussing was first revealed to the FDA back in 1982 (bailey et al). The FDA did NOTHING until Public Citizen filed a petition in 1996 seeking both black box warnings and dear doctor letters. The FDA did neither. Another petition was filed by the Attorney General of the State of Illinois in 2005 seeking these same actions. In 2006 Public Citizen once again petitioned the FDA. Rather than respond to these petitions as required by law, the FDA stonewalled the petitioners for more than three years. It was not until suit was filed in Federal Court by Public Citizen to compel the FDA to respond to these petitions did the FDA do anything.
Bayer issued a European "Dear Doctor Letter" in February of 2008 in regards to fatal liver injury as a result of being on Avelox. Yet we see no such letter being issued here in the States, nor do we see the FDA requesting one either. This class has been crippling and killing patients since the mid sixties. For more than forty years now the FDA has hidden the true safety profile from both the patient as well as the treating physician. The FDA is also grossly misleading when they state that the risk factor is one in one hundred thousand. The actual risk is .5% to 16% depending upon which citation you prefer to reference as well as the year in which it was published.
Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org
fqresearch@aol.com
davidtfull@aol.com
Of further interest is the fact that over in Europe restrictions have recently been place on both Avelox as well as Norfloxacin due to severe adverse reactions.
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My name is Chris Brown and i would like to show you my personal experience with Levaquin.
I am 50 years old. Have been on Levaquin for 5 days now. I think this is a very strong and dangerous drug. While some people may take it with no problems, many people are having severe and debilitating problems which seem to last and last. I do not think this drug should be prescribed for simple infections. There are other safer drugs to try first.
I have experienced some of these side effects-
After 3rd dose, experienced vision distortions - seeing shapes going up the wall, colored spots floating in front of my eyes, spent a night of total sleeplessness. On day 4 noticed a little tightness in my calves. I attributed it to the gardening I was doing. On day 5 woke up with very tight calves. It was painful to walk and very painful to go down stairs. When I got to work I googled side effect of Levaquin and saw all the problems people have had with taking it. I have been off of the medication for three days and still have a great deal of pain in my calves. I have difficulty walking and have had to discontinue any strenuous activity. I have never had a bad reaction to any other antibiotic. I hope these symptons go away soon. My doctor just said he would note "muscle aches" on my chart and said "all antibiotics have some side effects.
I hope this information will be useful to others,
Chris Brown
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Hello Gary this is attorney David Ennis and thank you for your blog post. I am not a Doctor, but we always recommend to communicate with your Dr. any side effects you may be having on medication. Also if your problems persist you may want to get a second opinion. I am glad you have not had a tendon rupture at this time. Unfortunately many of our clients have experienced tendon ruptures without any notice. Good luck and let our readers know how you are doing.
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I have been on Cipro for 4 days now and I have noticed that my achilles tendon on both sides ache and the backs of my legs seem tight. I would also like to point out how quick the doctor was to prescribe this to me for a sinus infection. Seems like overkill to me. Are they not aware of the risks? I have discontinued use of it and hope I do not experience any adverse effects from it now.
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