“Black Box” Warning Issued for Levaquin and Cipro

Scott Kappes
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Posted by Scott KappesJuly 14, 2008 5:11 PM

Last week the FDA announced that fluoroquinolone antimicrobial drugs, like Levaquin and Cipro, would now carry the agency’s strictest warning. Antimicrobial drugs are used to treat or prevent certain types of serious bacterial infections, including pneumonia. These drugs have been linked to an increased risk of tendinitis and tendon rupture. The FDA notified manufacturers that the Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits outweigh the risks associated with the medications.


The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. 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. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

The FDA also notified drug manufacturers that a Medication Guide should now be provided with this class of medication to ensure that patients understand the risks that they may be exposed to. The agency advised physicians that caution should be exercised when prescribing fluoroquinolones and said that each patient’s risk should be evaluated on a case-by-case basis.

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Rose
Posted by Rose
July 14, 2008 9:40 PM

In December of 2007, I became ill with pneumonia. My doctor prescribed Levaquin 500 mg once a day for ten days. The only reaction he said I might notice is nightmares. Well, that was an understatement! After I took the first pill, I reacted very negatively. I went to bed that night with severe heart palpitations and I had the most terrifying panic attacks of my life. I really believed that I might die that night. I could not fall asleep. I kept “hearing” someone screaming in my ear every time I was almost ready to go to sleep, and I was having double vision. I was tossing and turning and freaking out. I finally went downstairs and laid on the couch so my husband could get some sleep. I got terrible sleep for only about 2 hours that night. I also had a terrible “headache” which was more like a sharp pain in the back of my head that lasted the entire time I was on the Levaquin. In the morning, I called my doctor to tell him that I had a reaction. His response to me (through the nurse) was that I had anxiety. He said I should keep taking the Levaquin and also take the ativan he was going to prescribe for me. At the time, I figured he knew best and that this reaction would be temporary. I had to somehow get through this course of Levaquin.

Within two weeks of stopping the Levaquin, I began having a burning pain in my left arm on the inside of my elbow. I wondered if I had a blood clot. That lasted a few days before it started to spread throughout my whole arm. I was experiencing agonizing, throbbing pain. Within another couple of days, my other arm was affected. I couldn't bend or straighten my arms. In addition, I was still experiencing heart palpitations and insomnia. Soon the pain spread to my legs. My knees hurt so bad, I couldn’t bend them to go up or down the stairs. All I could do was to sit and cry. Within the next few days and weeks I had the following adrs: blurry vision, dry eyes, dry mouth, ear pain, neck pain, shoulder tendonitis, popping, cracking joints, dizziness, nausea, diarrhea (I lost 6 pounds in two weeks), headaches, muscle twitching, muscle cramping, muscle jerking (myoclonic jerks), joint pain, EXTREME muscle weakness and soreness. My legs could barely hold me up and I was walking very slowly and stiffly. I couldn’t stand for more than a few minutes. I had pulsating, tingly neuropathy in my legs and feet that was very uncomfortable. My ankles were aching, my fingers were stiff, I had burning pain in my knees, I was even having spasms in my eyes. I had terrible pain and achiness in my lower back, I became very sensitive to noises (if things were quiet and I heard a noise, the right side of my face would spasm).

I am now almost seven months out from the initial reaction, and things have not gotten much better. I am still experiencing many of my original ADRS, just not as intensely as I was experiencing them. My worst problems are still pain in my left leg, stiffness in my feet, lower back pain, nervousness and internal tremors, blurry vision in my right eye, gastro-intestinal problems, intermittent tinnitus, and tachycardia.

I believe that reactions to FQs are grossly underreported because many people do not make the connection between their symptoms and the drugs. I am actually one of the lucky ones to have made the connection to prevent a repeat in the future. Also, I tell everyone I know about what happened to me and I believe I am saving people from suffering the same fate.

Db Cipro
Posted by Db Cipro
July 15, 2008 1:54 PM

The fact that Cipro and quinolones can cause permanent, untreatable tendon damage as highlighted by the need for a black box warning, that leaves patients with crippling untreatable pain, is only the tip of the iceberg when it comes to the other severe and permanently disabling adverse reactions that Cipro and other quinolones can inflict. The product information sheets provided by quinolone manufacturers fail to indicate that some individuals will suffer from multiple adverse reactions that will become permanent and untreatable. They list a wide variety of adverse reactions that would seriously impair anyone's quality of life, psychological, neurological as well as physical, if one had to live with only a few of them for life. Some of these reactions can develop days, weeks or months after taking these pills as well, making if more difficult to identify the drugs as the culprit of the disease.

I as well as numerous other individuals, who have tried to report these reactions to their physicians and the FDA, have been 'ignored' or 'rebuffed'. I have a ‘constellation’ of symptoms from taking Cipro in 2006 that do not respond to treatment. My permanent adverse reactions include tinnitus, hyperacusis, visual distortions and light sensitivity, smell and taste perversion, insomnia, anhedonia, chronic fatigue, anxiety and severe depression, loss of appetite, peripheral neuropathy, hypertension, hyperlipidemia, hypothyroid, brain fog, memory problems, constipation and 25 pounds of weight loss in addition to the muscular and degenerative bone issues. Tendonitis is a small part of the entire picture. If you find this hard to believe, check the ADR lists for Cipro and Levaquin. They’re all listed, but are considered “rare” reactions. Only tendon damage and peripheral neuropathy are indicated as possible permanent adverse reactions. What I and many others dispute is how “rarely” they occur, and we report that many of these adverse reactions cannot be treated and remain permanent long after taking the drugs. And when people report that they do occur after taking Cipro, or Levaquin, doctors are reticent to admit they were caused by the drugs, especially if they develop in these 'constellation' of maladies.

I feel sick every day, every minute of every day since July 2006. This is consistent with many of the reports of other individuals who took these quinolone drugs and experienced these 'constellations' of reactions that remain permanent till this day. My condition has deteriorated over these past years and continues to do so. No doctor has been able to treat any of my symptoms, let alone explain why they happened all at once.

If Cipro can damage tendons, it certainly can damage other organs and muscles…which is why so many quinolone sufferers report a constellation of symptoms - because this class of drugs has the potential to cripple every system in the body, physiologically, neurologically and psychologically. There is a compilation of evidence at More ... , which should be reviewed by the FDA and medical profession. We hope that eventually the FDA will reexamine their data, that people will be taken seriously when they report these symptoms, that there will be stronger warnings as to the other permanent side effects of Cipro and related drugs, and that serious research efforts will begin to determine why this class of antibiotics are so damaging to some individuals, so others will not be injured.

BTJ
Posted by BTJ
July 15, 2008 5:51 PM

I was on a 21 day run of levaquin and I am feeling horrible since. I finsihed the scrip, but started to emassive pain and weakness in my shoulders and knees. This stuff is just really bad. Now I see that they never had this "black box" warning. I feel like a victim. My Dr. said it was an antibiotic. Who would think it would disable you.

ciprovictimalso
Posted by ciprovictimalso
July 24, 2008 2:00 PM

These medicines should have been black boxed long ago. The warnings on them have been insufficient & still are. My husband took Cipro & CiproXR. Around 11 months afterwards both times, his tendons & muscle began to rupture. He was in his early 40's when this began, not 60's. Some occurred with no warning. Around a dozen different doctors had no idea what was causing this. I can understand why. The "AFTER" on the warning needs more clarity. People over 60 aren't the only ones who need to be concerned about ruptures. I don't believe the highest number of people reporting these injuries were in their 60's, but a younger age group. It seems that tendinitis & ruptures seem to be the most concern for adverse reactions caused by these medicines. What about neuropathies, severe muscle & joint pain that affects mobility & use of hands, the psychologital reactions such as severe depression, suicial thoughts & actions, psychotic episodes..etc. There are so many more. My husband suffers from quite a few adverse reactions after taking Cipro & CiproXR. As far as the wording "RARE", how do you know that's true when these injuries aren't getting recognized. My husband is proof of that. He had 6 ruptures & not a single doctor he saw knew why. The Black Box warning still falls short on making doctors aware of the possible risks patients face, so how can doctors warn their patients. It's just the same old story with the same old ending only with more people injured added to it.

ciprovictimalso
Posted by ciprovictimalso
July 25, 2008 4:16 PM

I'm sure most lawyers are aware that a lot of hurricane victims such as "Katrina" were given Cipro & other medicines. I often wonder about the cause of the elevated rate of tendon ruptures in the military over the years. I wonder if any of the recent "disqualified or totally restricted clinical investigators" worked on any quinolone research. I wonder about a lot of things.

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