Levaquin Blog

Here is an interesting story from NY Daily News contributors’ Drs. Positano (DPM) and Dines (MD), who practice sports medicine at the Joe DiMaggio Sports Medicine Center at The Hospital for Special Surgery and at the NY Presbyterian/Weill Cornell Medical Center. In a discussion about a sports injury to Indianapolis Colts safety Bob Sanders, they explain the various treatments and concerns when dealing with a ruptured biceps tendon.

X-Ray Vision: Distal biceps tendon tear more than likely leads to surgery

As if the Colts secondary has not been tormented by enough injuries this season, we recently learned that safety Bob Sanders will be out with a distal biceps tendon rupture at the elbow which will require season-ending surgery. The surgery was performed by the renowned orthopaedist Dr. James Andrews earlier this week.

The biceps muscle is an important muscle in the upper arm. The distal tendon of the biceps muscle transmits all of the forces of the muscle to the forearm at its insertion (radial or bicipital tuberosity), thereby contributing to an athlete’s ability to forcefully flex the elbow as well as rotate their forearm in turning the palm upward (supination).

The distal biceps tendon can tear, preventing the transmission of forces from the muscle to the forearm bones. While it can happen from repetitive injury in athletes, it more commonly results from a single traumatic event in which the flexed elbow is resisted or even traumatically extended as in Sander’s case. The event is usually accompanied by a “popping sensation” and sense of sharp tearing around the elbow crease.

Once a distal biceps tendon is ruptured, it unfortunately will not heal on its own. Rather, the tendon will continue to retract away from the bone and slide up the arm as the muscle contracts without resistance. Over time, the tendon will be come stiff and scarred as well. This loss of biceps muscle function results in a loss of elbow flexion (bending the elbow) and forearm rotation strength.

Usually the presentation of a distal biceps tendon is not subtle in the athlete. When compared to the normal arm, the tendon can no longer be palpated at the elbow flexion crease. Frequently, there is swelling and bruising around the elbow flexion crease.

The diagnosis can be made by taking a history from the patient and performing a physical exam. An MRI often can confirm a complete tear of the tendon as well as to assess any potential retraction of the tendon. Over the past few years, surgical techniques and implants have improved, which, when combined with people trying to stay more active, has led to an increasing number of distal bicep tendon repairs being performed.

In the past, 2 incisions were typically needed to repair the tendon whereas now 1 is often used. Patients are protected in a brace for the first 6 weeks after surgery after which they progressively work on strengthening exercises before returning to sports. The best results are achieved when surgery is done within three weeks of the initial injury.

Source: http://www.nydailynews.com/sports/football/2009/11/15/2009-11-15_xray_vision_.html?print=1&page=all

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Five Illinois residents have filed suit against Johnson and Johnson, Ortho-McNeil Pharmaceutical, Johnson and Johnson Pharmaceutical Research and Development and Walgreens after they say an antibiotic caused them severe tendon problems.

Plaintiffs Susan Price, Jerry Mahlandt, Johnna Woosley, David Force and Rachel Speiser say they took the antibiotic Levaquin, which is normally prescribed for upper respiratory infection, urinary tract infections, prostatitis and other bacterial infections.

What the plaintiffs claim they did not know at the time they took Levaquin is that it causes a higher incidence of tendon injuries, including tendon rupture, in people who are older than 60 or who are on corticosteroid therapy, according to the complaint filed Sept. 2 in St. Clair County Circuit Court.

“Levaquin-induced tendon injury involves the degradation of the tendon tissue, leading to severe and permanent injuries,” the suit states.

As a result of their taking the antibiotic, all the plaintiffs say they suffered severe and permanent tendon injuries.

Levaquin is part of a class of antibiotics known as fluoroquinolones and was originally introduced into the U.S. in 1997, the complaint says.

When Levaquin entered the market, warnings about tendon side effects were required on all fluoroquinolone labels, but were buried in a long list of potential adverse reactions, the plaintiffs claim. In addition, the warnings did not advise that tendon injury was tripled with fluoroquinolone use in people older than 60 and in those who are on corticosteroid therapy, according to the complaint.

In fact, Levaquin manufacturers marketed the drug toward the elderly, especially those with upper respiratory infections who were likely to be chronic corticosteroid users, the suit states.

“More disturbingly, Defendants’ promotional campaign was themed on Levaquin’s excellent safety profile and failed to disclose the risks of tendon injury,” the complaint says.

After world-wide studies revealed the tendon risks to Levaquin users, the defendants updated their label for the antibiotic, the plaintiffs claim. However, the new warning only included information about the risks to people who were on corticosteroid therapy and contained no warnings about risks to the elderly, according to the complaint.

“Accordingly, despite the 2002 label change, Levaquin prescriptions only increased and tendon injuries mounted,” the suit states.

Other European countries began discussing the requirement of heightened label change as early as 2001, and collaborated with Johnson and Johnson PRD to perform a study on the antibiotic’s effects, the complaint says.

The plaintiffs claim that Johnson and Johnson PRD, however, only analyzed achilles tendon ruptures in its study and did not assess the risk of Levaquin tendon toxicity. In addition, Johnson and Johnson PRD created an algorithm that excluded nearly 70 percent of health claims for the elderly who suffered Achilles tendon rupture, according to the complaint.

“The algorithm used CPT procedure codes that only related to surgical repair,” the suit states. “This algorithm thereby excluded all those Achilles tendon rupture cases where the patient was casted or booted, as is the case in the elderly population. By manipulating the data, Defendant Johnson and Johnson PRD was able to exclude the very group that was prone to tendon rupture.”

As a result, the Johnson and Johnson PRD study found no increased risk of achilles tendon rupture and found neither age nor corticosteroid use altered the findings, the complaint says.

As a result, the Levaquin label was not changed as had been recommended.

Because the defendants issued no warnings to doctors, physicians continued to prescribe the antibiotic, the plaintiffs claim.

However, Levaquin was responsible for 1,044 reports of tendon injuries and 282 reports of tendon ruptures from 1997 through 2005, according to the complaint.

Injuries continued to soar as Levaquin’s popularity increased, the suit states.

Even the Illinois attorney general took notice and in 2005 submitted a petition to the FDA requesting that a black box warning be placed on the antibiotic’s label, the complaint says.

Although the black box warning was not been placed on Levaquin’s packaging, a revised label was placed on the antibiotic in April 2007. However, the plaintiffs say the label continued to bury warning about tendon risks and did not contain a warning about Levaquin’s greater association with tendon toxicity as compared to other fluoroquinlones.

Finally, in July 2008, a revised Levaquin label contained a black box warning, but still fails to warn about its higher risk of tendon toxicity compared to other similar antibiotics, according to the complaint.

In the 10-count suit, the plaintiffs allege strict liability, negligence, breach of implied warranties, breach of express warranty, common law fraud, violation of the Illinois Consumer Fraud Act, unjust enrichment, breach of warranty and failure to warn.

Johnson and Johnson and its subsidiary, Ortho-McNeil, are named as defendants because they test and manufacture Levaquin. Walgreens sold the plaintiffs the drug, the suit states.

The plaintiffs are seeking actual and compensatory damages, plus costs, pre- and post-judgment interest and other relief the court deems just.

By: Kelly Holleran

Source: www.madisonrecord.vom

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Here’s a story (and some advice) from Ball Quick Athletics concerning the special risks weightlifters face when prescribed Levaquin:

Antibiotics and Injuries: Which Class of Antibiotics Can Bring Your Lifting Career to a Screeching Halt?

It’s almost that time of the year. Football season is just beginning, my lawnmower is getting less and less use, and the temperature is fluctuating more than the stock market. And the season wouldn’t be complete without an endless stream of antibiotics coming from the doctors’ offices. But before you go begging your doctor for an antibiotic for that runny nose, there’s one class of antibiotics that you better be particularly concerned about, especially if you lift heavy weights.

And that class is…. Fluoroquinolones (i.e. Cipro, Levaquin,etc)

Introduced in the 1980s, this class antibiotics is becoming increasingly popular with each passing year primarily due to the increase in antibiotic-resistant infections. Used most commonly to treat pneumonia and bronchitis, nowadays doctors are using them to treat just about everything. In fact at my pharmacy, they’re quickly creeping up the list of most popular antibiotics dispensed, right behind amoxicillin, azithromycin, and bactrim ds.

And why should you care… Tendon ruptures (those things that connect your bones to your muscles)

99 out of 100 doctors aren’t going to ask you if you lift weights. In fact, 99 out of 100 doctors are probably going to tell you squatting 300 pounds is extremely dangerous:-) So it’s your responsibility to be aware of potential tendon problems associated with fluoroquinolone use.

Even though they’re rare (most experts agree the odds are probably 1 in 100,000), the results can be extremely devastating, especially to an athlete or weekend warrior. In fact, in 2008 the FDA required that all fluoroquinolones carry a black box warning indicating potential tendon problems associated with their use (the equivalent of wearing the scarlet letter). And what is even more concerning to you and I, we’re already at a higher risk because a potential risk factor for tendon rupture is participation in sports, which includes weightlifting. In addition, you’re even further at risk if you’re taking corticosteroids like prednisone. Even inhaled corticosteroids for allergies (Nasonex, Flonase, Nasacort) put you at a higher risk.

Another important fact: Just because you finished your 10 day course of Cipro without any pain, don’t think you’re out of the woods just yet. There’s been documented cases of tendon ruptures 6 months AFTER using a flouroquinolone.

How will you know? Snap, crackle, pop.

The most commonly affected tendon is the Achilles tendon. However, they can affected virtually any tendon in your body. Symptoms range from stiffness and redness surrounding the tendon to complete inability to move the affected joint. Usually the pain is quick and intense.

I saw firsthand what Levaquin can do. My mother began a 5 day course of Levaquin, and had to stop after 3 days because of the tendon pain. It was so bad she couldn’t even walk up and down the stairs. And the worst part: it took 3 weeks for the pain to subside. And this is a lady who has passed 2 kidney stones without any pain medication stronger than Tylenol.

So what’s your options? Ask

Ask for a different antibiotic. Tell the doctor you lift weights, and you don’t want to risk injury. If you have pneumonia and are relatively healthy, ask for a z-pack. It’s considered first line anyways (plus it’s also a lot cheaper). With antibiotics, there is usually always alternatives. With so many of them out today, there’s almost always overlapping coverage for different types of bacterial infections, unless of course you have something truly funky going on.

More questions?

Here’s the best review I’ve found regarding fluoroquinolone-induced tendon ruptures: “Fluoroquinolone-associated tendinopathy: a critical review of the literature.”

Source: http://ballquickathletics.com/blog/?p=204

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Tendons are the tough fibers that connect muscle to bone. For example, the Achilles tendon connects the calf muscle to the heel bone. Tendon injuries typically occur near joints, such as the knee, ankle, shoulder and elbow. Tendon injuries could occur suddenly, but usually it is the result of many tiny tears to the tendon that have happened over time.

What causes a tendon injury?

Tendon injuries are usually the result of gradual wear and tear to the tendon from overuse or aging. Anyone can suffer a tendon injury, but people who make the same motions over and over in their daily activities are more at risk to damage a tendon.

A tendon injury can happen suddenly or gradually over time. A sudden injury is more likely to occur when the tendon has been weakened over time.

What are some symptoms of tendonitis?

Tendonitis usually causes pain, stiffness and loss of strength in the injured area.

• The pain may get worse when you use the tendon.
• There may be more pain and stiffness during the night or when you get up in the morning.
• If there is inflammation, the area may be tender, red, warm, or swollen.
• There may be a “crunchy” sound or feeling when the tendon is used.

How is a tendon injury diagnosed?

How is tendonitis treated?

There are many home remedies available for minor pains.  These include:

• Resting the affected area, and avoiding activities that worsen the pain.
• Applying ice for 10 to 15 minutes at a time, up to two times an hour, for the first three days.
• Continuing using ice as long as it provides relief.
• Taking over-the-counter pain relievers such as ibuprofen if needed.
• Stretching and exercising to prevent stiffness.

Doctors might also suggest physical therapy. With severe and long lasting injuries, doctors may see fit the use of a splint, brace, or cast to hold the tendon still.

It could take weeks or months for a tendon injury to heal. If the injured tendon is used prematurely, more damage could occur.

Source: Yahoo Health

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