Tag Archives: achilles tendon rupture

Doctor in the House – Levaquin: One MD’s Opinion

2 Feb

Here’s a nice summary of the risks of Levaquin and why it is still on the market;

Dear Dr. Donohue: Just how dangerous is the drug Levaquin? I read that it should not be given to a person over 60…
- A.S.
Dr. Dohohue: Levaquin (levofloxacin) is a newer antibiotic that has rescued many from dangerous infections and has been lifesaving for quite a few. Common side effects include nausea, diarrhea, dizziness, insomnia, headache and constipation. Those are potential side effects of almost all drugs.

More-serious side effects are tendon inflammation and even tendon rupture. The Achilles tendon, the heel cord, is the one most often affected. The medicine makes some people quite sensitive to sunlight and sunburn. It has caused liver and kidney damage. It might affect the way the heart beats and could cause dangerous heart rhythms. These things are more likely to happen to people over 60. With all this, how could such a medicine be allowed on the market? These outcomes are exceedingly rare, and the drug’s benefits greatly tip the scales in its favor.

Source: http://www.herald-review.com/lifestyles/health-med-fit/article_2906a269-7b4b-543d-ace6-7ab9abc4909b.html

As Dr. Paul Donohoe, a nationally-syndicated columnist whose health article is carried in over 175 newspapers, states (although if you’re reading this you’ll know we strongly believe that these results are anything but “exceedingly rare”, as most people would not have even thought, let alone reported, that a tendon injury could possibly be caused by a pill that they’ve only taken a few times days, weeks or months earlier), there are significant benefits unique to Levaquin.  This doesn’t change the fact that there are dangerous risks associated with the drug, and the “unique benefits” in many cases do not benefit the consumer, whose ailments oftentimes may be fixed with a less drastic measure.

As for the complaints consumers (and we at LevaquinBlog) have, it is not enough that the “benefits outweigh the risks” for the drug to be on the market.  What is necessary, both morally as well as legally, is that these risks are known by the same people who learn about their benefits.   That is, if we are going to hear how great it is (Levaquin is so wonderful! You only need to take 5 pills instead of 21!), then the risks should be equally available and accessible.  And this didn’t happen.  While the studies were available to Orth-McNeil, they did not properly warn the public (including consumers and doctors) until the FDA forced its hand.

That is the cause of all the lawsuits out there – not that Levaquin causes these terrible symptoms, but that Orth0-McNeil knew about these risks and didn’t warn us until it was too late.

Kickback Update: The “Scary” Power J&J Yields

18 Jan

As a follow-up to last week’s breaking news about the Johnson & Johnson / Omnicare kickback scandal, some details are emerging (see below).  It seems that J&J was making illegal payments to pharmacies to promote their drugs, which were being reimbursed by Medicare and the good ol’ taxpayer.  So not only did you suffer that achilles tendon rupture, but you and your taxes paid for the marketing efforts behind it, too.

Some of the emails released include the following gems:

  • In 2002, J&J’sLevaquin antibiotic saw a 19 percent share gain in five months. The reaction of one executive, informed of the news in an email was that it was “scary” that the company had such power.
  • When Omnicare demanded money from J&J, the J&J exec wrote in an email to a colleague: “I wasn’t going to go to jail for Dan, Omnicare, or for that matter J&J”.

Here’s the statement J&J gave after the complaint was filed:  “We are reviewing the complaint filed today and will address the government’s lawsuit in court.  We believe airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.  We look forward to the opportunity to present our evidence in court.”

Read the full story here: http://industry.bnet.com/

Case Study: Death by Levaquin

9 Oct

I’d like to bring attention to a study done by Doctors Andrew W Gottschalk and John W Bachman of the Mayo Clinic Department of Family Medicine. The case study involves an elderly man given Levaquin for a presumed brochitis who developed complete tendon ruptures of both of his Achilles heels. This drug’s side-effect was directly responsible for his subsequent physical and psychologic decline and unfortunate death.
   

The doctors found that with Achilles tendon rupture, as with hip fracture in the elderly, ‘the best offense is a good defense’. Steroid co-medication is a known risk factor for tendinopathy, and thus should be avoided when placing a patient on levofloxacin, or indeed on any fluoroquinolone. Patients currently on corticosteroid treatment should receive trials with other antibiotics before levofloxacin is considered. Doses should be adjusted accordingly in patients with decreased creatinine clearance. All patients should be educated as to possible side-effects of treatment. The development of tendonitis is an indication for discontinuing therapy, and informing patients of the possibility of tendon distress may prevent severe complications. Levofloxacin is an expensive, commonly used antibiotic. Although this fluoroquinolone is often appropriate therapy under certain circumstances, their case reminds us that levofloxacin therapy has associated risks, which in their patient catalyzed a downward spiral resulting in death.

The following is a brief summary, or read the case study in full here:
 
An active senior, a farmer, came to the Mayo Clinic because his “feet [weren’t] working”. One month earlier, the patient was diagnosed with bronchitis at an outside clinic and was treated with a seven-day course of levofloxacin 500 mg by mouth, taken once a day. His heel pain began over the first four days of fluoroquinolone treatment. On the seventh day of treatment, upon dismounting his tractor, he noticed sudden, severe pain in both of his heels and a compromised ability to get around independently.
 
He had no history of tendinopathy. But MRIs of his ankles showed complete rupture of both Achilles tendons. He was fitted with casts for his heels and discharged from the hospital one day after admission. Five weeks after hospital admission, the patient’s casts were removed and he was fitted with controlled ankle motion (CAM) boots. Nine weeks after hospitalization, the patient was instructed to stop wearing the CAM boots and began wearing his own tennis shoes.
 
At his initial presentation to the outpatient care center on the day of admission, the patient’s primary care physician noted, “History of depression and anxiety: He is not anxious and depression is currently not a problem. He looks much brighter.” However, at the meeting with his orthopedic surgeon nine weeks after hospital discharge, both the patient and family members noted decreased energy levels and general lack of enthusiasm. There was concern that these symptoms were fueled by his immobility.
 
Ten weeks after diagnosis, the patient presented to the Emergency Department with a 22-pound weight loss over the prior two months as well as generalized lethargy. He was hospitalized for evaluation where he was hydrated and his antihypertensive regimen was modified. He was discharged with blood pressures well within the normal range and with close follow-up with his primary care physician. The patient was readmitted for inpatient care the following day with hospital-acquired pneumonia. He subsequently developed kidney failure, sepsis, heart failure, and a myocardial infarction. After consultation with the patient and his family, care was withdrawn and comfort care measures were initiated until the patient passed away 11 weeks after the initial diagnosis of bilateral complete Achilles tendon rupture.
 
In the study, the doctors show that tendon rupture can be deadly. Physiologically, their patient could not perform the farm chores his body had become accustomed to and could no longer actively prepare his own meals. Psychologically, his mobility had allowed him to interact with his family, friends, and coworkers on the farm. Immobility led to social isolation which led to a recurrence of his depression. This, coupled with his rapid deconditioning, resulted in disaster. 

 

Source: Journal of Medical Case Reports, Death following bilateral complete Achilles tendon rupture in a patient on fluoroquinolone therapy, by Drs. Andrew W Gottschalk and John W Bachman, available at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2631494

As always, we at LevaquinBlog hope you educate yourself before taking any medicine, especially one with serious known risks such as Levaquin.

WHAT IS A TENDON RUPTURE?

24 Sep

What is an Achilles tendon rupture?

By Jonathan Cluett, M.D.

An Achilles tendon rupture occurs when the tendon attaching the calf muscle to the heel is ruptured. This is a common injury, most often seen in middle-age, male, “weekend warriors.”

What are the symptoms of an Achilles tendon rupture?

An Achilles tendon rupture is a traumatic injury that causes sudden pain behind the ankle. Patients may hear a ‘pop’ or a ’snap,’ and will almost always say they feel as though they have been kicked in the heel (even though no one has kicked them). Patients have difficulty pointing their toes downward, and may have swelling and bruising around the tendon.

Which patients sustain Achilles tendon ruptures?

Achilles tendon ruptures are most commonly seen in men who are around the age of 30-40 years old. About 15-20% of patients have symptoms of Achilles tendonitis prior to sustaining an Achilles tendon rupture, but the vast majority of patients have no history of prior Achilles tendon problems. Over 75% of Achilles tendon ruptures are associated with playing ball sports (commonly basketball or tennis).

Other risk factors that are associated with Achilles tendon rupture include:

Cortisone injections into the tendon
Gout
Fluoroquinolone antibiotic use
Fluoroquinolone antibiotics are used very commonly in medicine for treatment of respiratory infections, urinary tract infections, and other bacterial infections.

These antibiotics, such as Cipro, Levaquin, and others, are associated with Achilles tendon rupture. Exactly why this is the case is unclear, but patients on these medications should consider an alternative medication if Achilles tendon pain develops.

What is the treatment for Achilles tendon rupture?

Achilles tendon rupture is most often treated surgically to reattach the tendon to its normal position.

Nonoperative management can be undertaken, generally people who live sedentary lifestyles or who may have problems with wound healing. Nonsurgical treatment of an Achilles tendon rupture is accomplished by casting the Achilles tendon for several months. In these patients, the number of reruptures is higher compared to those patients who have surgical repair. In patients who have surgery for an Achilles tendon rupture, less than 3% experience a rerupture of the tendon.

How is surgery done for treatment of an Achilles tendon rupture?

The surgery to treat an Achilles tendon rupture involves an incision along the back of the ankle. Usually the incision is made just to the side of midline so shoes will not rub on the site of the scar. The torn ends of the Achilles tendon are identified and strong sutures are placed in both ends of the tendon. These strong sutures are then tied together to repair the tendon.

What are the complications of Achilles tendon repair?

The most common and worrisome complications following an Achilles tendon repair are problems with wound healing. The skin over the Achilles tendon sometimes does not heal well. Therefore, careful wound management is of utmost important following surgical repair of an Achilles tendon rupture. Other potential problems include infection, ankle stiffness, and rerupture of the tendon.

What is the rehab following Achilles tendon repair?

Rehabilitation following Achilles tendon repair is a controversial topic. Traditionally, patients were casted after surgery for a period of 4 to 8 weeks and after that time, patients were allowed to gently move the ankle.

More recently, studies have shown that patients do well and heal faster with more rapid mobilization. If a solid repair is attainable, patients may not be casted at all, and allowed to begin motion immediately after surgery. These patients will use a removable boot when walking for several weeks.

Sources:
www.about.com
Saltzman CL, Tearse DS. “Achilles tendon injuries” J. Am. Acad. Ortho. Surg., Sep 1998; 6: 316 – 325.
Schepsis, AA, et al. “Achilles Tendon Disorders in Athletes” Am. J. Sports Med., March 1, 2002; 30(2): 287 – 305.
Peck, P. “Study Confirms Increased Risk of Achilles Tendon Rupture With Fluoroquinolone Use” IDSA 41st Annual Meeting: Poster 195. Presented Oct. 10, 2003.