Levaquin Lawsuit
Levaquin, also known as Levofloxacin, is a fluoroquinolone antibiotic made by Orth-McNeil. It is used to treat a multitude of infections including pneumonia, skin infections, and urinary tract infections. In fact, it is the only respiratory fluoroquinolone that the Food and Drug Administration approves for use in cases of nosocomial pneumonia. It was released in 1993 after fifteen years of testing proved it to be safe.
As with most medication, Levaquin has some side effects, although it is believed to be generally well tolerated. Some of the more common side effects are nausea, diarrhea, itching, abdominal pain, dizziness, flatulence, rashes, and vaginitis (in women). Some patients may experience blistering sunburns after being exposed to sunlight or the ultraviolet light from tanning salons. Your doctor will suggest that if you suffer any severe side effects, that you immediately quit taking Levaquin and contact him or her.
Now, some groups think that Levaquin may cause serious tendon damage as one of the side effects. Ortho-McNeil has stated that taking Levaquin may cause ruptures of the shoulder, hand, thumb, or Achilles tendon. They suggest in their literature that if you develop pain, swelling, or rupture of a tendon, that you quit taking Levaquin and immediately contact your doctor. Scientists are not sure why some patients taking this drug suffer ruptures, but believe it may be because the drug is toxic to tendons and decreased the blood supply to areas that are already receiving a limited amount of blood.
On July 8, 2008, the Food and Drug Administration (FDA) ordered Ortho-McNeil to put a “black box” warning on Levaquin warning patients of the potential risks as well as creating literature that stresses the risks associated with taking Levaquin. But, the FDA allowed the drug to remain on the market and did not issue a recall.
But, is the warning too late for some? The Public Citizen and Illinois Attorney General tried to get the FDA to add the “black box” warning on Levaquin in August 2006. An earlier petition had been filed in 1996 by a nonprofit group, asking for the same warnings. While the FDA did grant the 1996 petition, the chance of ruptures was merely added to the list of possible side effects and not emphasized as a serious risk. The FDA has stated that the benefits of the class of fluoroquinolone drugs like Levaquin outweigh any potential risks.
While it is believed that patients and doctors may be able to prevent the tendon ruptures with awareness of early warning signals such as tendon pain, there are still a large number of patients taking Levaquin who are reporting this problem. An FDA database shows reports of 262 cases of tendon ruptures, 259 cases of tendonitis, and 272 cases of additional tendon disorders. Of the cases reported to the FDA, 61% of the patients were taking Levaquin.
If you have been taking Levaquin and feel you have suffered tendon damage due to the drug, you may want to contact a lawyer to see what legal recourse you have.
August 17th, 2008 at 3:26 pm
“An earlier petition had been filed in 1996 by a nonprofit group, asking for the same warnings. While the FDA did grant the 1996 petition…”
The FDA did NOT grant the 1996 petition. Within the 1996 petition, filed by Public Citizen, they requested the following:
Actions Requested
1. Immediately require a warning in bold type in the official product labeling (package insert) for all fluoroquinolone antibiotics sold in the U.S. (see suggested wording below).
2. Immediately require that a MedGuide (patient package insert) be distributed with all new and refill fluoroquinolone prescriptions warning the public of possible tendon damage and informing the public to stop using the drug and contact their physicians if tendon pain develops (see suggested wording below).
3. Immediately inform all U.S. physicians through a “Dear Doctor Letter” by registered mail about the risk of tendon rupture with fluoroquinolone antibiotics.
4. Immediately inform all other U.S. health professionals through the FDA Medical Bulletin about the new warning.
The specific warning requested by Public Citizen is as follows:
Tendinitis and rupture have been reported both in the U.S. and abroad from the use of fluoroquinolone antibiotics most frequently involving the Achilles tendon. Reports have also been made involving the rotator cuff (the shoulder), the hand, the long tendon of the biceps and the long extensor of the thumb. This appears to be a rare but potentially serious class effect of fluoroquinolone antibiotics.
This reaction appears to be more common in those treated concurrently with corticosteroids; with increasing age; and in renal transplant recipients but cases have occurred in people without any of these risk factors. Onset of symptoms is sudden and has occurred as soon as 24 hours after beginning treatment. Most patients have recovered completely after one to two months. The onset of tendon pain calls for immediate withdrawal of fluoroquinolone antibiotics.
This is the warning that was added instead:
“Ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported with [the specific drug name]. [The specific drug name] should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur at any time during or after therapy with [the specific drug name].”
This warning was NOT in BOLD TYPE or Black Boxed. It was hidden within the package insert along with the laundry list of other adverse reactions associated with this class. Nothing was done to bring anyone’s attention to this new warning. NO Dear Doctor letters were sent, and other than a brief notice published by the FDA in an obscure FDA journal that is no longer even being published, nothing further was done to inform either the patient or the treating physician.
The latest petition seeking these very same changes was filed in 2005, and NOT 2006 as stated within this article. The Office of Attorney General, State of Illinois’s petition to the FDA was filed May 18, 2005. A full year before the one filed by Public Citizen. As such the FDA did NOTHING for a full three years regarding this issue until Public Citizen SUED them in January of 2008 for failing to respond to these petitions as required by law.
The numbers cited regarding what is to be found with the FDA database is also in error. The latest analysis showed them to be 50% higher than this article states.
Last but not least the FDA did NOT order Ortho-McNeil to put a “black box” warning on Levaquin. But rather pointed out the NEED for such an additional warning for all the fluoroquinolone drugs and REQUESTED that the various manufacturers do so.
Since this was done on July 8, 2008, the various manufacturers had until August 8, 2008 to reply to this request, and if they felt it to be unreasonable or unnecessary, they could disagree with the FDA stating reasons why they felt this to be so. The latest response from the FDA that we received on August 14, 2008 stated the following:
“We have asked the manufactures to box the warning regarding tendon ruptures. The new label has to be reviewed and approved by the FDA and that process has not been completed yet.”
So as one can see the FDA and the various manufacturers are once again dragging their feet concerning this issue. As of August 17, 2008, the FDA has yet to mandated such a warning be added. They simply asked nicely that this be done. The manufacturers may very well refuse to do so.
Nor did the FDA even ask that this Black Box Warning be added immediately. They may very well allow the manufacturers to exhaust their current stock of pre printed labels, which could take years, before the new ones become available. One also has to take into consideration the fact that the drugs currently in the market place would NOT benefit from this change, as they would still be using the old labels. The FDA also REFUSED to mandate the Dear Doctor Letters, which ALL three petitions, (the ones filed in 1996, 2005 and 2006) requested, which would have brought this to the immedate attention of treating physicians. Who to this day, even though this association has been reported since 1982, refuse to associate such injury with this class.
Since this ‘review’ of the tendon issues has been ongoing since 1982, more than two and one half decades now, it may very well take yet another decade before we see such Black Box Warnings within the package inserts.
Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
http://www.fqresearch.org
November 10th, 2008 at 10:37 pm
My mom was recently in the hospital because she had fallen. The doctor would not relay to us what the diagnosis was. He lied stating my dad had instructed him not to tell his children. We are a very close family and dad reiterated he would never do that. (We now found out they can get a bonus if transferred before 3 days) However, before transferring my mom over to a rehabilitation center a Dr. put her on Levaquin. We were not aware of this – nor that she had pnemonia. She kept complaining about her shoulder hurting but we thought it was because she had fallen. My mom also seemed confused as well. As soon as the 5 days of meds were up her memory returned. (Now looking at her records) However, they didn’t continue another antibiotic and are trying to cover their tracks… Sadly, my mom has past away and now we have a lawyer.
Levaquin is VERY BAD STUFF it is not only MIND ALTERING but as noted not good at all for the joints. Maybe the Doctors who want to prescribe it should try a dose of the medicine they prescribe. I miss my mom terribly and pray that the truth is known!
December 1st, 2008 at 8:02 am
I had tendonitis as a result of this drug in January which restulted in rotator cuff surgery. I was prescribed it again on Nov. 21 and again have tendonitis. Whom should I contact regarding joining the ongoing lawsuits?
February 10th, 2009 at 4:19 am
doc rxed cipro face swells x3 dont take call doc says swell went down retake does not work see doc gives me levaquin now severe burning armpits,mouth,anus area,buttocks spasming. same pharmacy filled scrips 60cipro 7 levaquin 1 1/2 day apart. levaquin says caution if allergy with cipro do not take. told doc no sleep 4-5days leva causes sleeplessness these drugs need closer regulation very bad nasty feeling anti’s
February 13th, 2009 at 5:45 pm
My mother was given Levaquin in the nursing home. She was not given an x-ray, a blood test or a sputim test in order to diagnose her illness, for which she was prescribed the Levaquin. The staff assumed she had an upper respiratory infection and that was their diagnosis. The nursing home doctor saw her five days before she died and said she did not need any medicine. So, I don’t know which is worse. She may have had a virus, which Levaquin will not touch. She had diabetes and no one at the nursing home monitored her closely or paid attention to the warning on the Levaquin. On the last day she was alive, her blood sugar was taken and the level was 353. They gave her two shots of insulin that afternoon and a few hours later, after five days on Levaquin, she passed away in the ER. The ER was one hour away from the nursing home and the only way I got them to send her to emergency was when I threatened to call the police department. I spoke to two nurses on two separate occasions and told them I wanted to see about changing her medication something was terribly wrong. The nurses basically ignored me. Our family was not aware of anything that was going on since we were not notified and told of her condition. Some warnings on Levaquin say it can cause a severe allergic reaction, damage liver and kidneys, and even cause death. She had severe pain in her right side, her head had dropped down onto her chest, she had labored breathing for days and days, and had lost her voice three or four days prior to her death. She was lethargic and I noticed her lower lip was red and swollen to twice or three times the size. When I saw her before she got onto the ambulance, I was shocked at the condition they had left her in. She was in her room alone, facing the window in her wheelchair, the doctor was at the front desk and the director of nurses was joking around with him, while my mom was dying two doors down, without anyone telling our family. My doctor recommends that I take Levaquin for my diverticulitis and swears it is the best thing going. To hear him pushing it, you would think it was some sort of miracle drug. I may need to change doctors because I am not sure he will honor my wishes and he may give me Levaquin even though I do not want it under any circumstances. I told him my mom was allergic to Levaquin, and he told me that does not mean I am. I am trying to find antibiotics that are not in the flouroquinolone family.
My mom was elderly and should never have been given this so-called medication under any circumstances. I am investigating the cause of her death and will be taking legal action in whatever areas I can to try and get someone to pay attention to what is happening.
April 8th, 2009 at 11:30 am
My wife was given a Rx for 2 months of Levaquin. After the first month she suffered from severe tendon pain everywhere. This has been going on since 12/01/2008 with no reduction at all of the pain. Both arms,shoulders,everywhere. No help from her doctor except iam sorry. Why would a doctor give someone a Rx of 24 pills with 1 refill and no instructions? This drug should only be giver for a few weeks at best.
April 20th, 2009 at 8:36 am
On September 11th, 2008 I was treated in the emergency. I came in with ear and throat infection. I was prescribed Levaquin 500mg for 10 days. I was only asked if I was allergic to any medications. I was not told about any side effects that would be caused by this medication. On my 4th days of this medication I was walking at a store and I collapsed. My legs were very week. I had to use a cane to walk due to loosing my balance.
I ended going back to the emergency by ambulance on the 7th day of the meds. The doctor did some tests and thought it was only the flu.
I was worried about my walking situation. I decided to check the medication on the Internet. I was very upset on what I found. The side effects were weakness in the knees, calf’s, ankles tendon damage and increased pain in my hands.
I am very upset about this! I placed a complaint on med-effect government website.
My life has completely changed. I was in perfect health before taking the medication. I have to use a cane to walk. I loose my balance. My knees, calf’s and ankles hurts and feels like it is burning all the time. I cannot walk my dogs any more. I cannot clean the house. My hands are so bad that I could only type with one finger on each hand. These are only a few things, the list goes on. (Pain emotionally and physically).
It is now April 2009 and still living in major pain.
May 4th, 2009 at 11:35 am
i was prescribed levaquin for a serious nasal infection. then i see a commercial for adverse side affects for levaquin. i do have a serious problem with my right shoulder this problem happened after takeing the levaquin
January 28th, 2010 at 8:17 pm
Iwas given Levaquin by my family physician (who is also a very good friend of my husband and myself. I had been suffering from continual utis. We would think I was well only to have the uti come back within a week or two. This went on for almost 3 years. Finally, we all said we had to try a differant approach. I was given a script for 10 days of Levaquin. I felt nauseated and finally told him, so he told me to take only a half a pill a day. I did this so my 10 day supply was about 16 or 17 days, but my uti didn’t come back. I went to the doctor I few weeks after I finished the med and I told him excitedly that I think we finally killed the infection, but my shoulder was killing me! I told him that one morning I had woken up in excrutiating pain, and I had done nothing to cause it. He came over and moved my arm, and then told me it was my rotator cuff. He signed on the computer and I could see it in his face. It was the Levaquin. Luckily I had an appt with my orthopaedic surgeon the next week. To finally finish this long story: I had an mri which showed a severe rotator cuff rupture, another shoulder tendon recently torn, and surgery was performed the next week. I am now 9 weeks post-op, and 2 weeks into physical therapy-my shoulder was kept immobile for about 8 weeks to allow healing from the pretty extensive surgery. I want the public to know what Levaquin can do,and how the pharmaceutical company did by not putting the black box warning and not notifying the doctors. I don’t blame anyone except them and the FDA for not enforcing this.I have contacted an attorney – if I don’t receive a cent for it, that is ok. At least I am getting the word out. Thank you for reading this.
February 15th, 2010 at 10:41 am
I WAS GIVEN LEVAQUIN 500 MG FOR 7 DAYS DUE TO PNEUMONIA. AFTER TAKING MEDICATION FOR 4 DAYS I NOTICED INTENSE BURNING PAIN IN BOTH KNEES. I HAVE BEEN OFF THE MEDICATION FOR 5 DAYS AND HAVE NOT NOTICED ANY RELIEF. I DID NOTICE HEAT IN THE JOINT OF ONE KNEE ALTHOUGH I HAVE NOT SEEN SWELLING. I AM TAKING MEDICATION FOR PAIN ROUTINELY AND I HAVE NOTICED THAT MY BALANCE IS OFF WHEN WALKING. I SPOKE WITH MY ORTHOPEDIST AND WAS TOLD THAT ONCE THE MEDICATION IS OUT OF MY SYSTEM I SHOULD BE PAIN FREE. NOT SURE HOW LONG THAT WILL TAKE.
June 9th, 2010 at 8:44 pm
I took Levaquin 500MG to treat a UTI. Two months later I woke up in the middle of the night with pain in my right achilles heal. It’s been three weeks now and the pain hasn’t diminished. I have also developed knee pain, tendon pain behind my knee, swollen legs/ ankles, and some wrist pain. My doctor diagnosed me with tendentious and referred me to a Rheumatologist. I have the appointment set for next week. my doctor didn’t tell me these were potential side effects. I would have never dreamed an antibiotic could cause degenerating pain. It’s depressing because I can’t go to the gym. I can’t ride my bike. I limp when I walk and it hurts. I now take the elevator to avoid taking the stairs when possible. I feel like an old person. It hasn’t gotten an better. Every day is seems a new symptom develops. I’m worried I’ll be like this for the rest of my life.