Fluoroquinolones Receive Black Box Label By FDA

Posted on July 30, 2008
Filed Under

by Katie Kelley
A group of antibacterial prescription drugs has recently been subject to a warning label increase by the U.S. Food and Drug Administration (FDA). The fluoroquinolone group consists of several various types of antibiotics that treat an array of bacterial infections.

The drug types within the fluoroquinolone family include:

* Levaquin (levofloxacin)

* Factive (gemifloxacin mesylate)

* Avelox (moxifloxacin HCL)

*Cipro XR and Proquin XR (ciprofloxacin extended release

*Noroxin (norfloxacin)

*Floxin (ofloxacin)

*Cipro (ciprofloaxacin)

With the new labeling, the drugs will now carry a black box warning label, considered the strongest label given by the FDA. While no recall has been implemented, the dangers are becoming more apparent among the most common risk for the fluoroquinolone drugs which is Achilles tendonitis/tendon rupture.

What is Achilles Tendonitis?

Achilles tendonitis is the inflammation or irritation of the Achilles tendon. Individuals who have taken any of the fluoroquinolone prescription drugs, especially the more common Cipro, may be at risk for Achilles tendonitis, which often results in the tendon rupture or tear. If Achilles tendonitis does lead to a tendon/muscle tear, the chances for surgically operating to treat the tendon rupture are high. Cipro was associated with Achilles tendon rupture in a study published in Clinical Rheumatology in February 2004.

Because scientists and researchers are finding an increased risk of Cipro-related tendon rupture, it is important for any individual who has previously taken Cipro - even if it was anywhere from 1 week ago to 6 months, 2 years or prior - that the patient speak with a physician, especially if they are experiencing pain or swelling of their muscles.

Uses for Cipro

Cipro, is manufactured from Bayer A.G., and is one of the more commonly prescribed fluoroquinolone prescription drugs. It is used to fight the following bacterial infections as well as other bacterial condensations:

* Enterobacteriaceae

* Vibrio

* Haemophilus influenza

* Neisseria gonorrhoeae

* Neisseria meningitidus

* Moraxella catarrhalis

* Escherichia coli (E. coli)

* Mycobacterium intracellulare

Cipro has also been approved to treat the symptoms of an anthrax attack.

Cipro Side Effects

In addition to the severe tendon rupture risk associated with taking Cipro, the prescription antibiotic has also been linked to other discomforting and painful side effects. According to Medline Plus, a service of the U.S. National Library of Medicine and the National Institutes of Health, some of the additional side effects include:

* nausea

* vomiting

* stomach pain

* vaginal itching/discharge

* paranoia

* nightmares or abnormal dreams

* anxiety

* indigestion

* diarrhea

* headache

* nervousness

* agitation

While the previous side effects may seem as if there are average or normal when taking a prescription drug, Medline also included a list of several side effects that will require a patient to discontinue their use of Cipro immediately, as their health may be at risk. These more severe side effects are as follows:

* rash, blisters, hives or itching

* tingling or swelling of limbs, face, neck, throat, lips, eyes or lower legs

* loss of muscle strength

* numbness

* hoarseness

* fainting

* suicidal thoughts/tendencies

*depression

* hallucinations

* seizures

* confusion

* burning sensation, weakness of body

* fever

* joint or muscle pain

* jaundice

* double vision, dizziness

* loss of energy, tiredness

* easy bruising or bleeding of body

* loss of appetite

Preventing Harmful Cipro Risks

Individuals who have been adversely affected by the potentially harmful Cipro side effects are advised to contact an experienced pharmaceutical lawyer, as a Cipro attorney will be able to provide legal consultation and individual assistance for a lawsuit. The risks associated with Cipro are clearly dangerous and some may be life-long lasting side effects. In which case, an individual affected by the prescription drug’s dangers should develop a pharmaceutical lawsuit to be reimbursed for the damages caused.

Visit one of the Flouroquinolone family drug sites, such as Cipro, at http://cipro.legalview.com or Levqauin at http://levaquin.legalview.com/. Also use the LegalView homepage to find other controversial pharmaceutical risks such as the Avandia side effects.

Article Source: Article Junction

Comments

9 Responses to “Fluoroquinolones Receive Black Box Label By FDA”

david fuller on July 31st, 2008 12:07 am +2

Rather than retype this comment over and over, as so many sites are running with this story, I would beg pardon from the host of this site to allow me to paste this comment, which has been spell and grammar checked for errors as well as submitted to those other sites. I believe it captures the concerns of those who have been injured by this class and hence a relevant comment to this story, as well as adds the facts that have been deliberately excluded by the FDA within their press release:

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.

I just received a report of a 14year old male who tore the cartilage in both knees requiring extensive surgical intervention as a result of being on levaquin to treat a nail infection. Not to mention they young lady who has been in a wheelchair for the past decade due to the damage done to her tendons which rendered them beyond surgical repair. She was given cipro for an earache.

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.

And what they did was nothing more than a ’slap to the face’ to those of us who have had our lives destroyed by these drugs. It is far too little, far too late. And we would not even be tossed this ‘bone’ if this lawsuit were not pending. This is nothing more than a blatant attempt by the FDA to avoid full disclosure of the true safety profile of this class which will be required when they lose in Federal Court.

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.

Those who have an interest in reading this forty years worth of medical journal entries, case reports, newspaper articles, clinical studies, etc., that documents all that I state here are invited to log unto http://www.fqresearch.org 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.

I find the manufacturers to be grossly misleading the patient and physician alike when they state that this class is a safe and effective antibiotic with minimum side effects. I have forty years worth of medical documentation that proves that they are anything but for those who care to read it, rather than this line of misleading and false information being provided by the FDA.

Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
http://www.fqresearch.org
fqresearch@aol.com
davidtfull@aol.com

Of further interest over in Europe they have recently restricted the use of Avelox and well as Nofloxacin due to the severity of the side effects.
JR on August 1st, 2008 5:03 am error

David,

Thanks a lot for your deep information as I believe this will bring more knowledge and value to other readers, as well.
david fuller on August 1st, 2008 6:22 am +1

Tried to submit this editorial but I guess it is too long for the comment window. Here is the link to it : hxxp://tinyurl.com/5vqfsy

I wrote this in response to a propaganda video from a doctor over at John Hopkins who attempted to minimize and trivialize these reactions. The video was posted on MedScape and I have to give the good doctor credit for keeping a straight face while making it.

Appreciate your encouragment JR, but I have been saying the same things for almost a decade now and they have not made a bit of difference.
Ty Taylor on August 1st, 2008 4:18 pm +1

I was a healthy 42 year old male who took Levaquin for a sinus infection. The same day as the Black Box Warning was issued; I was having my third tendon reattachment surgery.

This one was for my right bicep and rotator cuff. I have to wait 3 months before I can undergo yet a fourth tendon rupture reattachment for the left side. I also suffer from Achilles Tendinopathy, joint pains, headaches, uncontrolled muscle twitching etc.

For a sinus infection, I am sure there is a more suitable class of antibiotics that could have cleared this up. Fluoroquinolones should only be used as the drug of last choice.

Many people are walking out of their doctor’s office with a prescription in hand for one of these antibiotics to treat a sinus or bronchial infection. It’s a game of Russian roulette that they didn’t sign up to play.

Many will wind back up in their doctors office or worse the ER to treat the side effects, only to be scuffed at because most physicians are unaware of these side effects or how to treat them. I hope that one person will read these blogs and think twice before popping one of these dangerous drugs.
JR on August 2nd, 2008 3:23 am +1

@ david :

If you want a warning sign about these drugs to be more well-noticed by others, I’d be glad to post it here and give a link back to the source article. You can pass me the article then - thanks.

@ ty :

I am truly sorry to hear what happened to you but thanks for your comment as I will spread the words about these drugs more heavily through this blog with the help from David.

I believe your input here will help so many others so they won’t have the same uncomfortable experience.
Sally C. on August 11th, 2008 2:04 am (subscribed to comments) +0

I am a victim of an adverse reaction to Avelox,also a fluoroquinolone antibiotic.
The Black Box warning brings attention to the issue of tendon rupture. However, there are a host of other adverse reactions that are not warned against in a black box and NEEDS to be.
I suffered central and peripheral nervous system damage. Anxiety, insomnia,tremors, burning, body-wide pain, seizure and malaise. I could barely stand in the several months following the ingestion of Avelox.
It is now 3 years since I took Avelox and I suffer short term memory loss and peripheral neuropathy. Before this event, I was athletic and fit. I exercised daily. I rode bikes and did weight bearing exercises.
Today I am limited in my ability to execise. I tire more easily. And if I am not careful, the pain can become debilitating.
Avelox changed my life. And if it had a black box to warn me of CNS and PNS damage, I probably would have passed on taking it.
I took a life changing drug to cure sinusitis and bronchitis where another antibiotic would have been just as effective.
These drugs should be the drugs of last resort. Doctors are too quick to get out the big guns with no regard to the side effects. I blame the drugs companies for this and the hard sell of the pharmaceutical reps.
There are thousands of us! And I wish that ALL the adverse effects were prominently shown on these medications so that there wouldn’t be thousands more.
Connie on August 12th, 2008 9:10 pm +0

My husband is a former Marine. He was in excellent physical condition even after being honorably discharged years ago. He was in his early 40’s when he first took Cipro. He started having problems around a month after taking Cipro. The bottom left corner of his lip swelled. It looked deformed (angioedema of the lip). Little sores appeared around his ankles. His arms and legs started an involuntary jerking movement especially when he tried to rest. He started having really bad muscle and joint pain. Insomnia, anxiety, panic attacks, vivid nightmares, rectal bleeding, severe depression, agitation and so many more things were happening at this time. There were also suicidal thoughts and acts. The first rupture occurred in his left calf around 11 months after taking Cipro. He had 2 more after that which involved the quadriceps in his right leg. A quadriceps muscle tore apart in the center of his right thigh. Tendons aren’t the only thing that can rupture. For several years the rupturing seemed to have stopped. He took Cipro XR. Around 11 months after the rupturing started again. This time both his arms were involved. He had 3 more ruptures. All the other adverse reactions he previously had became far worse after taking this medicine for a second time. He’s disabled now.
Genevieve on August 13th, 2008 6:46 pm +0

Norfloxacin completely destroyed the quality and potentially the quantity of my life. This stuff should not be prescribed, unless for life-threatening situations, and the patient should be warned of the potentially dire consequences, so that an educated decision can be made.
Bob on August 30th, 2008 4:18 pm +0

Bob from Lincoln UK

I took 7 days of a 28 day course of Ofloxacin in November 2007
Had to stop the meds due to intense pain in my knees and shoulders.
4 weeks in: -
hardly walk with severe swellings in knees , ankles and hips.
6 weeks in: -
Toxic psychosis, depression, anxiety and suicidal thoughts
9 months in: -
Pain in joints and muscles, tendons popping in every single joint but worse in spine.
Chronic back pain
Worsening of pre existing Tinnitus
Burning sensations on hands and feet.
Flushing sensations
Bee like stings all over
Feeling of being cold even in hot weather.
Urinary problems
New symptoms manifest themselves every week
Symptoms are progressive and not transient as stated in the prescribing literature.
I am 43 but feel like 63.
If you have Prostatitis or any infection that HAS NOT been cultured refuse Fluoroquinolones until they can confirm its life or death, honest it is just not worth the risk.
BE WARNED YOU QUALITY OF LIFE MAY DEPEND UPON IT!!!!!!!!!!!