Levaquin: News And Information

Levaquin (levofloxacin) is a fluoroquinolone class antibiotic manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson (also the manufacturers of the dubious Ortho Evra patch). Administered by injection, oral solution, or tablets, it is used to treat many types of bacterial infections ranging from pneumonia to urinary tract infections. Interestingly enough, Levaquin is also used as a preventative measure for those exposed to anthrax.

Although it was FDA approved in 1996, it wasn't long before it was again under review. In 2002 and 2007 the warning label was amended to include a warning about the risk of tendinitis and tendon rupture. Most recently, in July of 2008 the package insert, or label changed again to include the so-called "black box" warning which emphasizes the risk for tendinitis and tendon rupture in all ages, but especially for those over 60 and who are also taking corticosteroids.

The serious side effects and injuries associated with the use of Levaquin and other antibiotics of the fluoroquinolone class such as Cipro and Avelox, include the following:

• Tendonitis / Tendinitis
  
• Tendon Rupture
  
• Rotator Cuff Tear / Injury
  

The tendinitis and tendon ruptures can occur in the Achilles tendon, the rotator cuff (shoulder), the biceps, the hand, and the thumb.

Now, lawsuits are being filed all over the country related to tendon injuries incurred by fluoroquinolone antibiotic use. Avelox and Cipro are of the fluoroquinolone class as well, however Levaquin has the distinction of having the most lawsuits filed to date.

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Photo courtesy Ricky Romero on Flickr.com

On July 8, 2008 the FDA announced that a so-called "black-box" Warning would be added to the package insert, or label, to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture associated with the following fluoroquinolones:

Ciprofloxacin (marketed as Cipro and generic ciprofloxacin)
Ciprofloxacin extended release (marketed as Cipro XR and Proquin XR)
Gemifloxacin (marketed as Factive)
Levofloxacin (marketed as Levaquin)
Moxifloxacin (marketed as Avelox)
Norfloxacin (marketed as Noroxin)
Ofloxacin (marketed as Floxin and generic ofloxacin)

For more details, see the July 8 press release, "FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs".

A fibrous tissue which attaches muscle to bone, the tendon functions to allow our bodies to move and stretch through a pulling motion. Tendons are designed to withstand great tension. This elasticity of tendons allows them to pull, but also act as springs which can hold energy.

Tendon rupture is actually quite uncommon. It occurs when the connective tissue pulls away, snaps or tears. Either way it happens, it is extremely painful. If left untreated, a tendon rupture can become a permanent disability.

Typically a tendon rupture is the result of trauma. Yet recently there have been more and more cases of tendon rupture associated with fluoroquinolone antibiotics such as Levaquin, Cipro, and Avelox. Most often a tendon rupture occurs in the biceps, the Achilles, the rotator cuff, and the quadriceps, although there have been cases of rupture in the hands, fingers, and feet.

Symptoms

From WebMD.com:

An injury that is associated with the following signs or symptoms may be a tendon rupture:

A snap or pop you hear or feel

Severe pain

Rapid or immediate bruising

Marked weakness

Inability to use the affected arm or leg

Inability to move the area involved

Inability to bear weight

Deformity of the area

Symptoms associated with specific injuries:

Achilles tendon rupture: You will be unable to support yourself on your tiptoes on the affected leg (you may be able to flex your toes downward because supporting muscles are intact).

Rotator cuff rupture: You will be unable to bring your arm out to the side.

Biceps tendon rupture: You will have decreased strength of elbow flexion and decreased ability to raise the arm out to the side when the hand is turned palm up.

Treatment

Then first step to treatment when you suspect you have ruptured a tendon is the RICE method: Rest, Ice, Compression, Elevation. In many rupture injuries, long term immobilization is the treatment of choice, especially in patients middle-aged and older. However, very serious tendon ruptures, and especially those which occur in the Achilles, do end up requiring surgery.

WebMD.com describes the surgery for a rotator cuff rupture or tear:

If the tear is either less than 50% of the cuff thickness or less than 1 cm in size, the dead tissue is removed arthroscopically. A small incision is made and a tool called an arthroscope is passed into the joint. Through it, the surgeon can see and remove dead tissue without actually cutting the joint open. The shoulder is then left to heal.

Recovery

Non-operative recovery time from a tendon tear or rupture is normally shorter, and there is less risk of infection. However, without surgery it is more likely that the tendon will not return to complete functionality. Surgical recovery, combined with physical therapy has proven to be very effective in restoring strength and functionality. This is, of course, contingent upon the location and severity of the rupture.

Top photo courtesy YetAnotherLisa on Flickr.com

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