Some Antibiotics Linked To Tendon Rupture; Public Citizen Petitions FDA For Stronger Warnings

Targets Fluoroquinolone Class of Antibiotics: Tequin, Levaquin, Cipro, et al.

The consumer advocacy group Public Citizen filed a petition with the FDA in late August 2006 requesting that the agency order drug companies to put a "black-box" warning about the risks of tendon rupture that have been associated with a class of antibiotics known as fluoroquinolones.  Some of these antibiotics are Bristol-Myers Squibb's Tequin, Ortho-McNeil's Levaquin, and Bayer's Cipro.

The August 2006 Public Citizen petition concerning antibiotics in the fluoroquinolone class also urged the FDA to require the drug companies to send out so-called "Dear Doctor" letters regarding the stronger warning and to requires pharmacists to issue patient medication guides showing the stronger warning.

According to an August 29, 2006 Associated Press article at least one of the affected drug companies thought the current label was adequate:

Levaquin's label already "clearly states" tendon rupture can occur during or after treatment with the antibiotic, said Ambre Morley, a spokeswoman for Ortho-McNeil Inc., the Johnson & Johnson subsidiary that makes the drug.

Jennifer Corbett Dooren, of Dow Jones Newswire, reported why Public Citizen disagreed with that position in a piece published by The Wall Street Journal on August 29, 2006:

The drug labels do warn of the risk of tendon ruptures but the warning is not contained in a black-box, which is considered the FDA's toughest warning. A black box warning is in bold type and is surrounded by a black box to make it stand out. It typically appears at the top of drug labels and any advertising of products that carry black boxes must also include warning information as part of the advertisement.

Public Citizen said the tendon warning is buried in a list of possible adverse reactions to the drugs and is not adequate to warn consumers and health-care providers of the risk. The current tendon warning was added after Public Citizen petitioned the agency asking for such a warning in 1996.

According to the August 2006 Public Citizen petition, the antibiotic-induced tendon ruptures have occurred in the Achilles tendon, the rotator cuff (shoulder), the biceps, the hand, and the thumb. The petition states that one causation theory is that fluoroquinolones are toxic to tendon fibers and may decrease blood supply in tendons that already have a limited blood supply.

As an aside, in April 2006 Bristol-Myers said that it would stop selling Tequin for other reasons.

(Posted by: Tom Lamb)

Comments

[Tom Lamb]

I appreciate you taking the time to describe the side effects that you believe were caused by your use of Levaquin.

As I am not a doctor, I cannot determine whether your condition is a Levaquin adverse reaction, but your presentation of what you have suffered through seems rather compelling.

As you express in your closing remark, if others have had similar problems with Levaquin I hope that you will let Katie (and people like her) know by sharing your experience with us, here.

Thanks for reading Drug Injury Watch.

[Katie]

I am a 47 year old woman who has been in great physical condition my whole life. I sometimes get a sinus infection in the winter time as the enviroment I live in is very dry so my Primary Care Physician has prescribed Levaquin for me as I have had some minor allergic reactions to Pennicillan and Sulfa in the past. I have taken Levaquin once or twice a year for 6 years now and besides the normal side effects I have always done relatively well with it. My doctor has always prescribed 500 Mg (oral pill) once daily for 10 days. In march of 2007 I had been trying to fight off a pretty nasty sinus infection and finally gave in to taking the Levaquin to clear it up. my doctor also prescribed a second dose in the event that the sinus infection did not clear up on the first dose. I do not like taking antibiotics if I do not have to and inevitably I sometimes have let my sinus infections go too long where they do not clear up completly on one dose. Four months went by and at the end of Jly I noticed I was having sinus problems again and so started another 10 day regiment of Levaquin. I was at the end of the dose when I woke up one morning and my knees were killing me. I have never had a knee problem in my life. Within a couple of days my hands and arms, especially my right side, were a little numb and I felt like I had pins and needles fom my elbows to my fingertips in both hands. The pins and needles turned to a burning like pain and at night while I was sleeping I kept waking up in a lot of pain. It felt like my muscles and tendons were being stretched and pulled apart. It is difficult to explain all I have been through as the pain in my arms and hands changes. Suffice it to say I am going on 5 months now of having to tolerate excruciating pain in my arms, hands and knees still. Of course I made an appointment to see my doctor and have been tested for everything under the sun and have been to 4 specialists. I have had a C-Spine MRI done, an EMG, X-rays of my knees, I have seen a Rheumatologist and a Neurosurgeon. Everything has come back inconclusive. I have every symptom of tendon and nerve damage in my hands and arms and although I knew nothing about Quinolones when this started, I am now convinced that this is a toxic reaction. The frustrating part is that my doctor is adamant about this not being an Adverse Reaction. She says she has only heard of this happening once or twice and that it is really rare. The neurosurgeon that I saw, however, seemed to agree that it could be nothing other than that and I would just have to wait for it to work it's way out of my system. He told me I had two years before the nerves in my hands and arms would actually die. I left there in tears and have been living a private hell since. I can barely work, I never know what time of day the pain will get intolerable, I feel like I have lost my life. I also want to point out for those of you who think people like me may be exagerating or a looney tune, I promise you I am a very normal hardworking wife and mother. I just decided to go online and see if I could diagnose myself since the doctors have not. It would be nice to talk to someone else who may be experiencing the same symptoms as I am.

[Tom Lamb]

Thanks for taking the time to add to this discussion. I hope you get some feedback from other people who have had or know about similar experiences.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Lorie]

Thank you for your work. Chronic sinus infections for many years prompted my Dr. to prescribe Levaquin. Eight days into the ten day dose the back of both calves turned bright red with broken corpuscles, and the Achilles tendons became very tender. A physician, of course, told me to stop. My concern is that event occurred in early August of this year and the tendons are still extremely tender most of the time. Additionally, tendon attachments on both sides of both elbows become excruciating with any lifting at all. Both symptoms are worsening. I'm wondering if any of your other readers have had similar long term symptoms.

Thank you for your consideration.

[Tom Lamb]

As I am an attorney and not a doctor, I cannot give you any medical advice.

On the legal side of things, while we are not involved in any litigation involving Levaquin, I recall seeing some law firms on the internet who appear to be looking for cases of tendon rupture caused by antibiotics.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Cathy]

I had partial knee replacement 1 month ago, My doctor put me on Levaquin and 10 days later I fell and my leg just bent back, It hurt very bad, so I called my doctor and I had to go in for xrays. he said I had ruptured my patella tendons, so I had to have another surgery 2 weeks ago. They put me on Levaquin again i had already taken 3 doses, and I just happened to be reading the drug information on levaquin, I about freaked out when I saw it could cause ruptured tendons. My doctor just told me to stop taking it and put me on another antibotic. I have been very conserned about this matter, Because now I am in a brace for 6 weeks straight. Any suggestions. I am only 36 years of age and a female.

[Tom Lamb]

I appreciate you taking the time to share your experience with Tequin.

Here is an information page about how you can submit a MedWatch report to the FDA which, in turn, will be conveyed to the drug company:

http://www.druginjurylaw.com/medwatch-report.html

Thanks for reading Drug Injury Watch.

Tom Lamb

[Dave]

Hi Tom,

Thanks for publishing Drug Injury Watch, I've added it to my health care "favorites" list.

I'm a 57 y/o athletic male who get sinus infections all the time. I usually have to take antibiotics at least 3 times a year for recurring infections. I used to be prescribed Biaxin or Avelox because I have an allergy to penicillin. About 5 years ago, I was prescribed Tequin for the first time and was told it was superior for treating sinus infections. It seemed to work well and I took it several times subsequent to that. However, in September 2004, I was playing in a senior ice hockey game and was skating normally, I wasn't hit or bumped, when suddenly I felt something "pop" in my right ankle. I couldn't skate anymore I was in such pain. I went to the orthopedic doctor and after getting an MRI, he said I ruptured the posterior tibial tendon in my right ankle. He said this was an unusual injury as this tendon is not one that ruptures easily as opposed to the Achilles tendon. I tried wearing a custom made Arizona brace for about a year in hopes it would help heal the injury without surgery but no such luck. In December 2005, I underwent a major ankle surgery to repair the tendon. I've been really debilitated by this injury and the subsequent surgery, which has it's own set of complications and chronic pains.

I'm lucky to be walking again but I can no longer participate in sports or anything beyond just basic walking or biking. I've skated and played hockey all my life. I've had my share of injuries but I've never had an ankle tendon rupture and neither have any of my teammates. I've been baffled by this injury for years and couldn't understand why this particular tendon would just pop without cause (i.e, getting banged, pushed or making some sudden stop). I never connected the dots until I started reading about this possible antibiotic/tendon rupture connection. I was taking Tequin off and on throughout that year for sinus infections. I'm sure there is no way anyone could say for sure that this antibiotic was the cause, but it sure is suspicious.

Just thought I would share this with you and your readers. Is there somewhere I can report this event to the drug company or the government?

Thanks again for your website.

Best regards,
Dave

[Tom Lamb]

In order to bring this apparent Levaquin side effect incident to the attention of Ortho-McNeil and the FDA, I suggest that you submit a MedWatch report to the FDA. Here is a link to an information page that will tell you how:

http://www.druginjurylaw.com/medwatch-report.html

Thanks for reading Drug Injury Watch.

Tom Lamb

[Robbi Johnson-VanAuken]

I took Levaquin before going to bed a couple weeks ago, for a sinus infection. I had taken it in the past w/ no problem.

Just recently I began a vite/mineral regimen.

Prior to taking the Levaquin for a sinus infection, I took my 'calcium'.

I am writing to say 'calcium' should be added to the label on the bottle which says 'Do Not Take With Antacids'. The label should read 'Do Not Take With Antacids or calcium supplement'.

I had sudden onset numbness, tingling, pain over every square inch of my body.

The ER was clueless. Six hours later, when discharged from ER, called Walgreen's which confirmed this was an adverse reaction and I should not have taken the Levaquin w/ a calcium supplement. (I am a 55y/o woman.)

I've now accrued about a $1500 expense.

I hope you can share this info w/ Ortho-McNeil, as the web sites I found were either under construction or for employees only. I fould no 1-800# for this company either.

Thank you for looking into this matter, and certainly any feedback should you be able to respond.

[Tom Lamb]

Thanks for the comment.

If you are diagnosed with a ruptured tendon and, thereafter, want some leads as to law firms handling this type of Levaquin litigation, please let me know; I can steer you in the right direction (our law firm is not involved in any Levaquin litigation at present).

Thanks for reading Drug Injury Watch.

Tom Lamb

[Margaret O'Connor]

I checked w/my pharmacist re: Levaquin side effect of Tendon Rupture after my sinus surgery had to be postponed.

Dr. wanted to have me on strong preventive antibiotics.

I always go to the Pharmacist and on line before purchasing any new medications.

I explained I have Neuropathy in my left foot, other nerve damage, same leg, 2 prior back surgeries and history of cancer. Had concerned re: Ruptured Tendon Risk.

She said drug was for short term use so shouldn'effect me

However, f I felt any pain in the effected area to stop taking it immediately.But to her knowledge it wasn't a common side effect.

The area is by my ankle and area surrounding it. Basically aligned to my ankle bone and is now popped out. It is not the usual place for it to happen I notice from website.
However it is where the tendon pain and swelling are.

I am in a lot of pain.

I'm glad I checked with the Pharmacist and did read the label however this web site is correct.

It was listed as one of the least of complications.

Even to the pharmcist.
This is quite a reputable Drug Store.

The Drug Companies run the show.

Now not telling the Pharmacist the whole equation.

I am in terrific pain as I write this and am going to follow the advice on this site and put my foot up and take something more for pain.

If you have a class action and believe I could help to change this problem so it does not continue please let me know.

This is another $50 I spent for the highest Tier Drug that I now cannot even take for my health problem or return.

That is another reason I always reserach my Medication.

I'm Paying even more now for something new I cannot return.

There are true and tried drugs that would be less expensive and do the job.

This is the worst pain I have ever had in this bad left foot.

I've only been on Levaquin for 4 days.

I believe the tendon has rupturd as it is swollen and painful.

Best Regards,