Antibiotic Reactions Rare, but Worthy of Warnings
Posted on: Tuesday, 15 July 2008, 12:00 CDT
After concerns were raised over severe side effects of antibiotics known as flouroquinolones, last week the Food and Drug Administration ordered manufacturers to provide additional warnings and cautionary literature for their products.
The Associated Press reported the two leading drugs covered by the warning are Cipro, made by Bayer, and Levaquin, which is made by Ortho-McNeil. For everyday purposes, Cipro is often used to treat urinary tract infections, while Levaquin is generally used to treat respiratory infections but both have been linked to tendonopathy in hundreds of patients in the United states.
Dr. Melvin Deese, and orthopedic surgeon at Summit Sports Medicine in Brunswick, said the issue is twofold.
"Cipro and others like it are commonly required antibiotics today because over the years germs more resistant to less powerful drugs," Deese said.
"This class of drugs, detrimental to the patient in two ways," He added "They slow the healing process and simultaneously destroy components of the tendons."
While the effects are most commonly seen in the Achilles, which is the largest most stressed tendon in the body, some reports also involved the rotator cuff in the shoulder, tendons in the hands and biceps.
Side effects initially manifest with pain, swelling and redness in joints and can eventually lead to tendon tears or ruptures. This problem can be debilitating for patients because tendons, which attach muscle to bone, are essential to joint mobility and movement.
Deese said adverse reactions can occur as quickly as a few hours after the initial dose and up to a few months after treatment has commenced. There is no way to determine if a patient is susceptible to the specific side effect before administering treatment, though manufacturers have called the tendon ruptures a rare side effect.
"It's not an allergic reaction, and it only occurs in a minority of patients," Deese noted. "But as more of it dispensed the potential for adverse reactions more pronounced and increasingly evident."
Flouroquinolones don't have an exceptionally long presence in the body but anyone who is diagnosed with the side effect should stop taking the drug. Less severe instances of the deterioration can be treated with non-steroidal drugs or anti-inflammatories like ibuprofen but extreme cases can require immobilization and even surgery.
The Associated Press reported that FDA officials stressed many of the serious injuries appear to be preventable if patients stop taking the drug at the first sign of pain or swelling in a tendon, call their doctor, and switch antibiotics.
Source: The Brunswick News
Related Articles
- A Drug With Efficacy Superior to That of Remicade at Inducing Closure and Healing of Fistulas Would Earn a 30 Percent Patient Share in the Crohn's Disease Drug Market
- Adult Drug for Psoriasis Shown to Be Effective in Children
- Not All Drug Deaths Involve Illegal Drugs
- Teens Turn Away From Street Drugs, Move to Prescription Drugs, New Report Reveals
- GSK's Offer Still Stands: Drug Maker Maintains Its Drug Giveaways for Low-Income Patients
- New Drug Formulation May Help Drug Addicts Quit
- China Focus: Chinese AIDS Patients Longing for Better Anti-Viral Drugs
- Bone Marrow Transplant Patient Accepts New Kidney Without Taking Drugs
- Patients Plead With Amgen for Parkinson's Drug
- Five Drugs Panned by FDA Drug Reviewer
Rate this article:
User Comments (27)
| 27. |
Posted by Bob on 08/30/2008, 12:12 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!!!!!!!!!!! |
| 26. |
Posted by Shankar on 08/14/2008, 16:26 Right from the day the symptoms appeared, I knew it was because of Avelox. The dr. prescribed it for bronchitis in Sept 07. The drug made me very weak and I had shortness of breath, then I seemed to have problem with the plantar fascitis, I'm sure it was because of avelox, then for the last 4 months, I have been having floaters and dryness in both eyes. all these problems bcoz of 14 day avelox.. this drug needs to be taken off and a lawsuit needs to be filed. |
| 25. |
Posted by david fuller on 08/09/2008, 16:39 Second case: " My wife took Cipro on July 3, 4, 2008. After the 2nd dose she had a severe cardiac reaction with chest pain and pressure, arm pain, lightheadedness, and heart palpitations leading to her blacking out. All of the cardiac tests indicated that she did not have a heart attack. The next day she had another set of cardiac symptoms followed by pronounced facial drooping and left side muscle weakness/partial paralysis. This appeared to be a stroke but MRIs and other tests ruled that out. The left side weakness persisted and she continued to get p.t. and additional out-patient tests to rule out other conditions. After 2 weeks she has left side weakness, tremors a la Parkinson’s & blurry vision. Last week, she began to have violent seizures intermixed with lengthy periods of trembling/shaking. Her eyelids forcibly snapped shut and her eyes rolled up into her head for hours on end. At times, she also lost the ability to speak. She was given several anti-seizure medications to no avail.” Rare? NO. The only thing rare about these reactions is anyone in the medical community having a clue or any viable treatment options to offer when they do. |
| 24. |
Posted by david fuller on 08/09/2008, 16:25 I received these two desperate emails within the past week. If such reactions are to be considered ‘rare’ this would be statistically improbable. What is ‘rare’ however, as one can see by these reports, is anyone in the medical field associating such reactions with the fluoroquinolones even though they have been stated as such for two and one half decades: First case: “I am writing on behalf of my brother and sister-in-law, a vital 32-year-old mother of 2 who is in dire condition after having taken Cipro for a post surgical uterine infection. She is suffering a whole slew of neurological and vision symptoms, is unable to open her eyes, is confined to a wheelchair and needs nursing assistance in their home…None of the many, many doctors she has seen believe the Cipro to be the cause of her problems and none are doing anything to treat her…” |
| 23. |
Posted by JennZ on 07/31/2008, 10:58 The side effects are applicable to all classes of flouroquinolones. I took Avelox for a sinus infection in February 2007. Four days in a row. By the fourth day, I was having extremem heart racing, feelings of dettachment from reality, and fainting spells. I went to the ER where I was told it was not the drug. I stopped taking the Avelox and the symptoms subsided (at least the heart racing, fainting and detachment.) About one month later, I suffered and continue to suffer from an abundance of nerve-related issues as well as connective tissue concerns. I have severe twitching, waves of pain, tendon pain in the foot, neuropathy and neuralgia, vision (floaters) concerns, tingling and buzzing, and muscle cramping. These symptoms come in cycles so I can be OK one day and horrible the next. OVeruse of any muscle group causes problems that will last for weeks. (Whipped cake mix, by hand, the other day and I could barely use my hands for two days.) This is costly as I have seen several physicians to treat these conditions. I have been depressed as a result of this condition and have made every attempt to *****rvere (as we all have). Get this stuff off the market! |
| 22. |
Posted by david fuller on 07/24/2008, 21:54 Black Box Warnings, Dear Doctor Letters, restrictions place on Avelox, 1000’s of patients claiming severe injuries, 100’s if not 1000’s of adr forums with tens of 1000’s of members worldwide, as well as more than 50% of these drugs removed from clinical practice, and last but not least the fact that Nalidixic Acid, upon which all these drugs are based, a listed cancer causing agent, I dare to ask: are we still to believe the following comment at the end of just about any article written about this class? 'The fluoroquinolones as a class are generally well tolerated; most adverse effects are mild in severity, self-limited, and rarely result in treatment discontinuation' “Repeat a lie a thousand times and it becomes the truth” usually credited to Dr Joseph Goebbels, Propaganda Minister of the Third Reich. I now credit it to those medical researchers who continue to state how safe and effective this class of chemotherapuetic agents are. For they have repeated this lie a thousand times a thousand times. Rather odd coincident that they are both (Goebbels, and these medical researchers who state such blatant lies) members of the medical community. |
| 21. |
Posted by david fuller on 07/24/2008, 21:46 FRANKFURT, July 24 (Reuters) - The European Medicines Agency has recommended limiting the use of oral moxifloxacin-containing medicines after finalizing a review of the safety of the antibiotics, the agency said on Thursday. The European body said it had concluded that these drugs should only be prescribed for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed. "The agency also recommended strengthening the warnings for oral moxifloxacin medicines," it said in a statement. Moxifloxacin, a fluoroquinolone antibiotic, is marketed by Bayer under its brand Avelox. At its July 2008 meeting, the agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of oral moxifloxacin medicines continued to outweigh its risks. However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, it recommended restricting their use in these indications. The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union. |
| 20. |
Posted by Lynne G on 07/20/2008, 15:47 Posted by Lynne G on 07/20/2008, 15:45 I had surgery in 2000 to remove a urinary bladder stone caused by a previous unnecessary and unsuccessful surgery for minor stress incontinence. I was given Cipro for weeks prior to the surgery and after. I was told that the inside of my bladder looked like raw hamburger meat. I continued to get UTIs while the bladder surface was healing. I was given Cipro many times over the next 5 years by 3 different physicians. I was 60 or over at the time. I was told by 2 physicians that I needed to be on Cipro for a year. After 5 months in 2005, I stopped taking the drug since I developed severe ear pain. I experienced about 20 side effects, tendon rupture, neuropathy, sensitivity to noises, balance problems, rashes and itching, sun sensitivity, fatigue, vision problems, to name just a few. I'm still disabled and suffering. What in the world will a black box do? This drug needs to be withdrawn from the market. |
| 19. |
Posted by Lynne G on 07/20/2008, 15:45 I had surgery in 2000 to remove a urinary bladder stone caused by a previous unnecessary and unsuccessful surgery for minor stress incontinence. I was given Cipro for weeks prior to the surgery and after. I was told that the inside of my bladder looked like raw hamburger meat. I continued to get UTIs while the bladder surface was healing. I was given Cipro many times over the next 5 years by 3 different physicians. I was 60 or over at the time. I was told by 2 physicians that I needed to be on Cipro for a year. After 5 months in 2005, I stopped taking the drug since I developed severe ear pain. I experienced about 20 side effects, tendon rupture, neuropathy, sensitivity to noises, balance problems, rashes and itching, sun sensitivity, fatigue, vision problems, to name just a few. I'm still disabled and suffering. What in the world will a black box do? This drug needs to be withdrawn from the market. |
| 18. |
Posted by Beebo on 07/20/2008, 15:33 The ADR from a derivative of fluoroquinolones changed my life for ever. From being healthy to suffering from day one with, cardiac, neurological, liver, kidneys, muscles, tendons, muscles, visual and auditory damage, debilitating weakness leading to being bedridden for many months, neuropathic pains, indescribable pains, and more. For those who want info strictly concerning the ADR, visit www.fluoroquinolones.org and a forum to exchange info, tips, and is diverse, and has a chatroom, where we meet every Thursday nights, visit: www.favc.info |
| 17. |
Posted by Bill Boykin on 07/20/2008, 15:33 5 days on levaquin - total body muscle soreness, resulted in double burst sholder tendons requiring surgery. Severe disorientation, still suffering bad muscle soreness and this 3 years after the prescription. Levaquin is bad stuff in my book. I've been somewhat successful recouperating from this with a constant diet and health regimen, although painful soreness is a constant companion I've learned to live with. |
| 16. |
Posted by Shine on 07/20/2008, 13:51 I was a healthy 38 year old before taking 10 days of Levaquin. Now I have joint pain, muscle twitching and pain, tingling and burning sensation of fingers and toes, multiple skin problems etc. etc..list goes on. Seeing different doctors to treat these side effects including a Nuerologist, Rhuematologist, Dermatologist etc. Unable to exercise due to horrible muscle, leg pains, I used to regularly exercise before Levaquin. Economic burden for last 6 months from the treatments too. FDA needs to take a look at this medicine again, just the black box warning isn't enough. |
| 15. |
Posted by Lou on 07/20/2008, 09:44 Flouroquinolones antibiotics (Levaquin, Cipro, Avelox) can be very dangerous. It’s imperative to understand the potentially insidious side effects and that research be spent on finding a cure. I was a healthy 43 year old male. 12 days of Levaquin has changed my life. I had never had a side effect from a medication. This dangerous drug is in a different league. My side effects from Levaquin include a deep ache in thigh, disabling tendon issues across achilles, groin, elbow, etc. I have tingling, numbness sensations, and muscle twitching. I need crutches now to walk, and some days cannot walk at all. This is my life now because of Levaquin. While the black box warning issued by the FDA is a start, it doesn’t go nearly far enough in describing the seriousness nor the scope of the side effects. It’s time to recognize the facts and not rationalize them away. Let’s not have more tragedies. |
| 14. |
Posted by John on 07/19/2008, 20:23 The dangers of fluoroquinolone drugs go far, far beyond tendon ruptures and have been known for a long time. Their toxic reactions include irreversible neuropathy and other neurological and soft tissue damage, endocrine complications, and psychosis. The list is a long one. And their occurrence is greater than we, and perhaps even doctors, are led to believe. And we risk these serious and often permanent reactions for what? A sinus infection? A simple UTI? A “boo-boo”? In my own personal experience even doctors, themselves seem to be too busy, lazy, or careless to even know much about the drugs they prescribe or even read the patient insert. The Black Box for tendon ruptures is “nice” but is late and hardly scratches the surface of recognition and education required for these drugs. |
| 13. |
Posted by David on 07/19/2008, 11:50 At age 46 I was given 750 mg of Levaquin for 21 days to combat epidytimitis in 2007. I had some mild side effects during the course of treatment, ie... mild insomnia, mild joint aches, and some skin itching. After finishing my course of treatment I have developed more severe muscle and joint aches and pains along with muscle weakness. Alot of my joints, especially my knees and wrists became very frail and prone to easy damage. At a year out I have experienced Severe joint pain (especially of the knees and leg muscles), weakness in the arms and neck, never-ending neck pain (constant muscle strains and pains), insomnia, anxiety, depression, dryness and vision issues with left eye, and various peripheral neuropathies. I have had periods of no symptoms followed by strong relapses (cycles).Prior to this adverse drug reaction I was very healthy and bicycle 7-10 miles a day. I have never regained the ability to aerobic exercise and have to constantly guard against joint damage. |
| 12. |
Posted by Teri on 07/19/2008, 09:13 I think it's great to see more publicity about fluoroquinolone side effects. Many doctors forget that patients have a right to be informed about side effects, or perhaps doctors are not informed of side effects well enough to have intelligent conversations about them with their patients. I had a conversation with my doctor about possible side effects of Levaquin before I took it, and my doctor never mentioned tendon disorders, and convinced me to take the Levaquin since it'd be no problem for me to switch to a different antibiotic if I did have side effects. Or so we both thought. Luckily my mom came across a publication by Public Citizen that talked about tendon damage by fluoroquinolones when I was 7 days into my 14+day course of Levaquin. I'd been wondering why my achilles were so sore and my calves so rock hard. Four years later with continued tendon and nerve pain, I'm still regretting that initial assumption that side effects go away when I quit ingesting the pills. But if this is what the result of 7 days of Levaquin is like, thank goodness for that article by Public Citizen that kept me from taking 14 days worth of pills. |
| 11. |
Posted by Carlo on 07/19/2008, 00:48 I took exactly 2500 mg (10 pills of 250 mg) of ciprofloxacin over a period of 5 days in the summer of 2007 . Because of Cipro I need a wheelchair now. I've always been a healthy person. I took part in squash, tennis, football and jogging. After taking the third pill the first signs started. I had joint and muscles pain in my calves and arms. Because it was on saturday I did not call my doctor. I did read the paper in the box of Cipro and it did not say to stop immediately. If I did stop I would have less problems. ****ed why don’t they warn us better. On monday I went to my doctor and he said it was from Cipro but he thought it would not harm to go further. He did not know what to do. MY SYMPTOMS IN ORDER OF APPEARANCE Joint pains Calves/Achilles Arms Hamstrings Shoulders Muscle pains Increased joint stiffness Dry ears Dry eyes Dry mouth and nose Insomnia Numbness feeling right foot Joint popping all over my body Dry sinus Ear pain Red skin after touching it / pressure on it It is almost a year after taking Cipro. I cannot walk because of pain in calves and Achilles. I need a wheelchair out of my home. |
| 10. |
Posted by farmer on 07/18/2008, 23:46 What about the fact that since they can trigger mechanisms that can induce ruptures months after taking them, how patients are impacted by steroid intervention afterward that often exacerbates their outcomes. Currently only a warning exists for concomitant steroid is on labeling. Also what about increased risks for patients who may be taking Statins and Cox II's also known to impact tendons. |
| 9. |
Posted by cbs on 07/18/2008, 22:46 took 28 pills of 500 mg levaquin in July 2001. My life has not been the same since. The drug (as confirmed by several doctors including mayo clinic) caused tendon damage all over my body, extensive peripheral neuropathy, vision damage, hearing damage, insomnia, severe fatigue, night sweats, non stop 24/7 muscle twitching in several areas, muscle weakness and numerous other issues. I was a very athletic individual and active parti****nt in the lives of my two young children. That all changed in July 2001. Seven years later, I have improved greatly, but it took 4.5 years to really see the healing begin. Even now, the tendons in my feet, knees and shoulders are still too damaged to allow me to play most of the sports I once loved including tennis, racquetball, running, baseball, etc. Stay away from this drug unless it is the ONLY option to keep you from dying. |
| 8. |
Posted by Connie on 07/18/2008, 22:06 I have a problem with these warnings. I believe them to be misleading as well as being totally insufficient. People over 60 as the higher risk of having a tendon rupture is just 1 thing I have a problem with. I believe people younger than 60 had the most reported ruptures."Rare occurrence of tendinitis & tendon ruptures can occur while or AFTER" is something else that I believe is misleading. My husband took Cipro & around 11 months AFTER he had a rupture. He took CiproXR & around 11 months AFTER his tendons started to rupture again. AFTER means quite a bit more than a few weeks. I have another problem with reading "physicians should warn their patients of the risks". Who's going to warn the physicians so that they can warn their patients? My husband saw almost a dozen different doctors & not 1 of them associated his 6 ruptures to Cipro. Believing that tendonitis & tendon ruptures is the only thing you have to be concerned about taking these medicines is wrong. Dear Doctor Letters SHOULD be sent to every single doctor along with more clarity about "after" along with "all "the serious adverse reactions. |
| 7. |
Posted by Evan P on 07/18/2008, 20:56 I'm a 27 year old male who finished a little over 6 weeks of ciprofloxacin in may of 2008. As I was on the drug I noticed increasing muscle and joint stiffness, dizziness, and neve problems such as eye twitching and icy pains shooting down my leg. I assumed these would abate when I stopped the drug, and continued to take it as the doctor refused to give me another antibiotic and I was desperate to get well. Big mistake. Within a day of stopping I had shooting pains down my legs, and my joints started hurting and cracking loudly when moved. I had constant muscle spasms, tightness and pain in my arms and legs that left me unable to leave the house for a week. I also developed a constant ringing in my ears for the first time in my life, which has not decreased since. Along with a host of other smaller symptoms. All of my symptoms are still with me over 2 months since stopping the drug and improvement has been very little. The black box warning should include all long lasting adr's including nerve damage. |
| 6. |
Posted by Seena Dawish on 07/18/2008, 19:34 I took Levaquin 2 months ago for a UTI. After the third dose, I went from a healthy 34 yr old to a 100 yr old woman. I had myalgia, extreme anxiety and panic, insomnia, tremors, neuropathy, tinnitus, blurred vision, and joint and tendon pain. Most of the symptoms have either diminished or gone away except for the joint and tendon pain, tinnitus, blurred vision, slight neuropathy, and some anxiety. There has not been one day in the past two months that I have not been in pain. Both my achilles tendons, both knees, both wrists, both elbows, both shoulders, and my right hip take turns hurting and aching. My quality of life has greatly dimished. Seena Darwish |
| 5. |
Posted by Db Cipro on 07/18/2008, 18:48 I have sustained over a dozen side effects from Cipro that have not gone away, since 2006. Tendon damage and weakness that goes along with that is a small part. Add tinnitus, neuropathy, depression and insomnia. And yet, I had no clue I would get these right after taking a week of Cipro. Apparently others are also injured but have not received relief. These drugs may work for many, but for the few they disable, they leave those injured to become collateral damage. |
| 4. |
Posted by Karen Fisher on 07/18/2008, 18:05 I was a healthy 42 yr old mother of three with a doctorate that I worked very hard to get. After taking 4.5 days of cipro for a simple UTI, I couldnt work for almost 3 months and I lost my practice. I suffered tendinosis, very painful, head pressure, vasculitis, peripheral neuropathy, tachycardia, and countless other adverse affects. It is 7 mos later and I am still suffering. There is no cure or treatment, just try to figure out a way to deal with the loss of function and ability to care for my children and to continue my career. All this is robbed from me. I now have multiple tumors over my body which I did not have before. I dont know what my future is now. I could have had a wonderful life. Now I look through tear filled eyes all the time. |
| 3. |
Posted by Ty Taylor on 07/18/2008, 15:27 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. I have to wait at least 6 weeks before I can undergo yet a fourth tendon rupture reattachment. At least it takes my mind of the Achilles Tendinopathy, joint pains, headaches, uncontrolled muscle twitching etc. I consider myself one of the lucky ones since so far it has not affected my kidneys, liver, heart, eyes and other side effects that many are dealing with from this class of drugs. I would urge a real journalist to take the time and look at the real number of cases. The Fda numbers are misleading. The clinical data coming from other counties are showing much higher rates of tendon ruptures and other life threatening side effects. |
| 2. |
Posted by Ty Taylor on 07/17/2008, 15:54 Great reporting. "though manufacturers have called the tendon ruptures a rare side effect." Of course they are going to say it's rare for a reason $$. "Flouroquinolones don't have an exceptionally long presence in the body but anyone who is diagnosed with the side effect should stop taking the drug" Why are you even talking about the half life of this drug. It's right in the prescribing information that this drug may cause permanent tendon damage and rupture even after discontinuance of the drug. I'm on my forth rupture and only 42. The FDA also fails to mention that many people have dela*** effects that don't even start until you have finished the course of these drugs. I urge anyone who calls themselves a journalist to visit the website stated above and cover the real story. . |
| 1. |
Posted by david fuller on 07/17/2008, 01:18 The package inserts clearly state that the patient is NOT to take a NSAID or steroids if they experience a reaction. This is not a rare event either. The risk factor is anywhere from .5% to 16% depending on what study you refer to and the year it was published. Those who have an interest in the true safety profile of this class are invited to read the more than 4000 medical journal entries that do***ent the horrendous safety profile of the fluoroquinolones to be found at www.fqresearch.org |
RSS Feeds