Seeks to Strengthen Warnings Concerning Increased Risk of Tendinitis and Tendon Rupture

The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

“Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations,” said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. “The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products.”

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be “new safety information” as defined in FDAAA.

The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs and to highlight new information concerning who may be at higher risk for this side effect.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language. These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).

Fluoroquinolone manufacturers are required to submit the safety labeling changes, including the strengthened warnings and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, or the FDA disagrees with the new language the company proposes, FDAAA provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information. In addition, in accordance with FDAAA, sponsors will be required to assess whether their REMS are achieving the goal of informing patients of the risk of tendon-rupture. These assessments may include a survey of patients’ and prescribers’ understanding of the risks of tendon-rupture and whether the Medication Guide is being distributed and dispensed with the drug.

Health care professionals should consider the potential benefits and risks for each patient. While most patients tolerate these medicines well, occasionally some will develop other serious adverse reactions that may include convulsions, hallucinations, depression, abnormalities in heart rhythm, or severe diarrhea.

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

Information for Healthcare Professionals on Fluoroquinolone Antimicrobial Drugs: http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm

Wallabies winger Clyde Rathbone says he is unsure when he will fully recover from a chronic knee injury that threatens his rugby career.

The ACT Brumbies are virtually resigned to the South African-born Rathbone playing any part in this year’s Super 14 season such has been his slow recovery from knee surgery.

Rathbone has been out of the game for almost 12 months with the knee injury and he admitted Wednesday he wasn’t confident of playing this season.

Rathbone, a former South African under-21 captain under World Cup-winning coach Jake White, last played for the Brumbies against the Golden Lions in Johannesburg on March 31 last year.

Chronic patella tendonitis ruled him out of the Wallabies’ domestic and World Cup campaigns.

The 26-Test winger underwent surgery to remove a bone spur in his left knee last November but he has been dogged by a slow recovery.

He started basic locomotive movement, involving running on a mini-trampoline, on the injured knee this week.

“I couldn’t say I’m confident that I think I’ll get out there and be able to play for the Brumbies this year,” Rathbone told The Canberra Times newspaper.

“I was happy with how it went, it came up well.

“It’s a step in the right direction, but it’s just one of those things where I really don’t know if or when I’ll be back.”

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SURPRISE — The MASH ward has a new patient.

Just as Rangers pitchers Brandon McCarthy and Kevin Millwood are getting healthy and preparing for their spring debuts, another pitcher is ailing.

Left-hander C.J. Wilson, penciled in as the team’s closer, has biceps tendonitis. Wilson hasn’t pitched in a game since Feb. 28. He has not thrown a bullpen session since his one hitless inning.

While Wilson and manager Ron Washington aren’t making too much out of the arm issues, pitching coach Mark Connor isn’t taking it lightly.

“We want to get it knocked out of there,” Connor said. “He was throwing the ball real good and this thing cropped up. We want to get it knocked out of there and get him back on the mound. I’m always concerned. Anytime a pitcher can’t pitch, I’m concerned.”

Wilson has been limited to playing catch on flat ground. Connor said there’s no timetable for Wilson to pitch again but he would have to throw at least one bullpen session before returning to the game.

Wilson said there’s nothing to be concerned about.

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Tendons are connective tissue bands that attach muscles to bones. The biceps muscle is located in the front part of the upper arm and attaches at the elbow and in two places at the shoulder. Biceps tendonitis, also called bicipital tendonitis, is inflammation that causes pain in the front part of the shoulder or upper arm.

How does it occur?

Biceps tendonitis occurs from overuse of the arm and shoulder or from an injury to the biceps tendon.

What are the symptoms?

You feel pain when you move your arm and shoulder, especially when you move your arm forward over shoulder height. You feel pain when you touch the front of your shoulder.

How is it diagnosed?

Your health care provider will examine your arm and shoulder for tenderness along the biceps muscle and biceps tendons.

How is it treated?

Treatment may include:

• placing ice packs on your shoulder for 20 to 30 minutes every 3 to 4 hours for 2 or 3 days or until the pain goes away
• taking anti-inflammatory medication
• getting an injection of a corticosteroid medication to reduce the inflammation and pain
• doing rehabilitation exercises.

When can I return to my sport or activity?

The goal of rehabilitation is to return you to your sport or activity as soon as is safely possible. If you return too soon you may worsen your injury, which could lead to permanent damage. Everyone recovers from injury at a different rate. Return to your activity will be determined by how soon your shoulder recovers, not by how many days or weeks it has been since your injury occurred. In general, the longer you have symptoms before you start treatment, the longer it will take to get better.

You may safely return to your sport or activity when:

• Your injured shoulder has full range of motion without pain.
• Your injured shoulder has regained normal strength compared to the uninjured shoulder.

In throwing sports, you must gradually rebuild your tolerance to throwing. This means you should start with gentle tossing and gradually throw harder. In contact sports, your shoulder must not be tender to touch and contact should progress from minimal contact to harder contact.

How can I prevent biceps tendonitis?

You can best prevent biceps tendonitis by doing a proper warm-up and stretching exercises for your arm and shoulder before your activity.

The rotator cuff, which has four muscles around the shoulder joint, are meant to control the shoulder’s position and keep it stable and in place. The pain that can be felt in the rotator cuff can be found about three inches below the top of the shoulder and is most commonly felt when reaching over the head or behind the back. The most common cure for the condition is rest. As with most tendonitis injuries that is the most known cure. There are other cures. Another is anti-inflammatory medication, or a course of cortisone and a local anesthetic can be given. The anesthetic can be given into the area around the tendon. Exercising the tendon with weights is another way to cure it and it will help build up strength in the tendon again after the injury.

An x-ray can be used and this might reveal a bony anatomy that has being pinching the rotator cuff tendons. An x-ray may only be given if the pain has not gone after all the above methods have being tried. A bone anatomy occurs between a bone in the top of the shoulder and a ball at the top of arm bone. There is a process called an acromioplasty that can be performed. This procedure will make more room for the rotator cuff tendons.

A steel tube that contains optical fibers, a lens and a light resource, it is inserted into the shoulder and the surgeon is then able to remove some of the bone that is causing a problem from the acromion, through two or three small ¼” incisions.

Another type of tendonitis in the shoulder is calcific tendonitis. This is caused by calcium deposits in the rotator cuff area. The symptoms of the injury is agonizing pain and stern restrictions of movement in the shoulder. Having an x-ray of the tendon will reveal calcium deposits in the rotator cuff or above the head of the humerus. As with Rotator cuff tendonitis, the symptoms are very much the same. Injections of cortisone and a local anesthetic into the tendon area should heal the problem. If this fails then a multiple punch into the calcium deposit should break up the deposit and relieve the problem.

Achilles tendonitis is one of the more common and difficult injuries to treat in athletes due to the individuals high level of activity and frequent reluctance to decrease or stop training. It is associated with pain in the back of the heel and 1″ to 3″ above it. The range of pain is from burning or prickly to shooting and piercing especially when running “uphill”. The danger is if left unresolved, the fibers of the tissue can become weak and rupture, accompanied by increased swelling and pain.

Some causes of this injury can be:

• Improper shoe selection
• Improper warm-up: lack of flexibility due to lack of stretching (see stretching exercises below)
• Direct trauma.
• Heel bone deformity (seen as a “growth” on the bone)
• Short Achilles (anatomical)
• Over-pronation- excessive inward roll of the foot while walking or running
• Sudden increase in training and excessive hill running

Helpful Tips:

• Avoid hills
• Ice after running
• Decease mileage

Stretching Images:

-hold each stretch for 15 seconds, heel lift(s) under the affected part .
Remember to see your doctor for professional guidance if you suspect that you have Tendonitis.

What is jumper’s knee?

Jumper’s knee, which is the same as patellar tendonitis, is a condition characterized by inflammation of the patellar tendon, which connects the kneecap to shin bone (tibia). The condition may be caused by overuse of the knee joint, such as frequent jumping on hard surfaces or other similar activity.

Jumper’s knee symptoms can be:

The following are the most common symptoms of jumper’s knee. However, each individual may experience symptoms differently. Symptoms can include things like:

• pain and tenderness around the patellar tendon
• swelling
• pain with jumping, running, or walking
• pain with bending or straightening the leg
• tenderness behind the kneecap

The symptoms of jumper’s knee may resemble other conditions or medical problems. Always consult your physician for a diagnosis.

How is jumper’s knee diagnosed?

and physical examination, diagnostic procedures for jumper’s knee may include a radiograph of the knee. This would involve a negative image of the knee, taken with photographic film, using exposure to x-rays or gamma rays passing through matter or tissue in the body.

Treatment for jumper’s knee:

Specific treatment for jumper’s knee will be determined by your physician based on:

• your age, overall health, and medical history
• extent of the condition
• your tolerance for specific medications, procedures, or therapies
• expectations for the course of the condition
• your opinion or preference

The best course of treatment for jumper’s knee is to discontinue any activity that is causing the condition, until the injury is healed. Other treatment may include:

• nonsteroidal anti-inflammatory medications
• rest
• ice pack application (to reduce swelling)
• stretching and strengthening exercises

Face it, our knees take a beating everyday and are key to keeping us fit. Even from an early age problems can start and get compounded as we grow older. School sports often cause damage to the knee as well and children need to be closely monitored in any sport while in the growing years. Here is a basic summary of what the does and some of the things that can go wrong.

What Do the Knees Do?
Who Gets Knee Problems?
What Causes Knee Problems?
How Are Knee Problems Diagnosed?
Arthritis in the Knees
Cartilage Injuries and Disorders
Ligament Injuries
Tendon Injuries and Disorders
Other Knee Injuries
What Kinds of Doctors Treat Knee Problems?
How Can People Prevent Knee Problems?
What Types of Exercise Are Best for Someone With Knee Problems?

What Do the Knees Do?

The knees provide stable support for the body. They also allow the legs to bend and straighten. Both flexibility and stability are needed to stand, walk, run, crouch, jump, and turn. Other parts of the body help the knees do their job. These are:

• Bones
• Cartilage
• Muscles
• Ligaments
• Tendons.

If any of these parts are injured, the knee may hurt and not be able to do its job.

Who Gets Knee Problems?

Men, women, and children can have knee problems. They occur in people of all races and ethnic backgrounds.

What Causes Knee Problems?

Mechanical knee problems can be caused by:

• A direct blow or sudden movements that strain the knee
• Osteoarthritis in the knee, resulting from wear and tear on its parts.

Inflammatory knee problems can be caused by certain rheumatic diseases, such as rheumatoid arthritis and systemic lupus erythematosus (lupus). These diseases cause swelling which can damage the knees permanently.

How Are Knee Problems Diagnosed?

Doctors diagnose knee problems by using:

• Medical history
• Physical examination
• Diagnostic tests (such as x rays, bone scan, CAT scan, MRI, arthroscopy, and biopsy).

Arthritis in the Knees

The most common type of arthritis of the knee is osteoarthritis. In this disease, the cartilage in the knee gradually wears away. Treatments for osteoarthritis are:

• Medicines to reduce pain, such as aspirin and acetaminophen
• Medicines to reduce swelling and inflammation, such as ibuprofen and nonsteroidal anti-inflammatory drugs (NSAIDs)
• Exercises to improve movement and strength
• Weight loss.

Rheumatoid arthritis is another type of arthritis that affects the knee. In rheumatoid arthritis, the knee becomes inflamed and cartilage may be destroyed. Treatment includes:

• Physical therapy
• Medications
• Knee replacement surgery (for a seriously damaged knee).

Cartilage Injuries and Disorders

Chondromalacia (KON-dro-muh-lay-she-uh) occurs when the cartilage of the knee cap softens. This can be caused by injury, overuse, or muscle weakness, or if parts of the knee are out of alignment. Chondromalacia can develop if a blow to the knee cap tears off a piece of cartilage or a piece of cartilage containing a bone fragment.

The meniscus (meh-NISS-kus) is a C-shaped piece of cartilage that acts like a pad between the femur (thigh bone) and tibia (shin bone). It is easily injured if the knee is twisted while bearing weight. A partial or total tear may occur. If the tear is tiny, the meniscus stays connected to the front and back of the knee. If the tear is large, the meniscus may be left hanging by a thread of cartilage. The seriousness of the injury depends on the location and the size of the tear.

Treatment for cartilage injuries includes:

• Exercises to strengthen muscles
• Electrical stimulation to strengthen muscles
• Surgery for severe injuries.

Ligament Injuries

Two commonly injured ligaments in the knee are the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL). An injury to these ligaments is sometimes called a “sprain.” The ACL is most often stretched or torn (or both) by a sudden twisting motion. The PCL is usually injured by a direct impact, such as in an automobile accident or football tackle.

The medial and lateral collateral ligaments are usually injured by a blow to the outer side of the knee. This can stretch and tear a ligament. These blows frequently occur in sports such as football or hockey.

Ligament injuries are treated with:

• Ice packs (right after the injury) to reduce swelling
• Exercises to strengthen muscles
• A brace
• Surgery (for more severe injuries).

Tendon Injuries and Disorders

The three main types of tendon injuries and disorders are:

• Tendinitis and ruptured tendons
• Osgood-Schlatter disease
• Iliotibial band syndrome

Tendon injuries range from tendinitis (inflammation of a tendon) to a ruptured (torn) tendon. Torn tendons most often occur from:

• Overusing a tendon (particularly in some sports). The tendon stretches like a worn-out rubber band and becomes inflamed.
• Trying to break a fall. If thigh muscles contract, the tendon can tear. This is most likely to happen in older people with weak tendons.

One type of tendinitis of the knee is called jumper’s knee. In sports that require jumping, such as basketball, the tendon can become inflamed or can tear.

Osgood-Schlatter disease is caused by stress or tension on part of the growth area of the upper shin bone. It causes swelling in the knee and upper part of the shin bone. It can happen if a person’s tendon tears away from the bone, taking a piece of bone with it. Young people who run and jump while playing sports can have this type of injury.

Iliotibial band syndrome occurs when a tendon rubs over the outer bone of the knee causing swelling. It happens if the knee is overused for a long time. This sometimes occurs in sports training.

Treatment for tendon injuries and disorders includes:

• Rest
• Ice
• Elevation
• Medicines such as aspirin or ibuprofen to relieve pain and reduce swelling
• Limiting sports activity
• Exercise for stretching and strengthening
• A cast, if there is a partial tear
• Surgery for complete tears or very severe injuries.

Other Knee Injuries

Osteochondritis dissecans (OS-tee-oh-kon-DRI-tis DIS-secans) occurs when not enough blood goes to part of the bone under a joint surface. The bone and cartilage gradually loosen and cause pain. Some cartilage may break off and cause sharp pain, weakness, and locking of the joint. A person with this condition may develop osteoarthritis. Surgery is the main treatment.

• If cartilage fragments have not broken loose, a surgeon may pin or screw them in place. This can stimulate new blood flow to the cartilage.
• If fragments are loose, the surgeon may scrape the cavity to reach fresh bone and add a bone graft to fix the fragments in position.
• Research is being done to investigate cartilage and tissue transplants.

Plica (PLI-kah) syndrome occurs when bands of tissue in the knee called plicae swell from overuse or injury. Treatments for this syndrome are:

• Medicines such as aspirin or ibuprofen to reduce swelling
• Rest
• Ice
• Elastic bandage on the knee
• Exercises to strengthen muscles
• Cortisone injection into the plicae
• Surgery to remove the plicae if the first treatments do not fix the problem.

What Kinds of Doctors Treat Knee Problems?

Injuries and diseases of the knees are usually treated by an orthopaedist (a doctor who treats problems with bones, joints, ligaments, tendons, and muscles).

How Can People Prevent Knee Problems?

Some knee problems (such as those resulting from an accident) can’t be prevented. But many knee problems can be prevented by doing the following:

• Warm up before playing sports. Walking and stretching are good warm-up exercises. Stretching the muscles in the front and the back of the thighs is a good way to warm up the knees.
• Make the leg muscles strong by doing certain exercises (for example, walking up stairs, riding a stationary bicycle, or working out with weights).
• Avoid sudden changes in the intensity of exercise.
• Increase the force or duration of activity slowly.
• Wear shoes that fit and are in good condition.
• Maintain a healthy weight. Extra weight puts pressure on the knees.

What Types of Exercise Are Best for Someone With Knee Problems?

Three types of exercise are best for people with arthritis:

• Range-of-motion exercises. These exercises help maintain or increase flexibility. They also help relieve stiffness in the knee.
• Strengthening exercises. These exercises help maintain or increase muscle strength. Strong muscles help support and protect joints with arthritis.
• Aerobic or endurance exercises. These exercises improve heart function and blood circulation. They also help control weight. Some studies show that aerobic exercise can reduce swelling in some joints

A condition known as tenosynovitis or wrist tendonitis as it is more commonly known is characterized by irritation and inflammation of tendons around where the wrist joints are situated.

Around the wrist joint there are many tendons which can be damaged. But with wrist tendonitis it usually only affects one certain tendon. Occasionally it can contain two or more tendons but this isn’t very common. It would have to be a really bad case of wrist tendonitis.
More often than not, wrist tendonitis occurs at parts of the tendon where they cross each other or pass over a bony part of the tendon. This disease tends to affect a lot of older people, or people who currently type a good amount when they are at their day job. This is because people who type for a living often shake up their wrist a good amount, and it often leads to one of the many kinds of diseases that can happen to the wrist, most of these diseases though can be seen as Wrist Tendonitis even though that they are not this very disease at all. As the wrist tendons pass by the wrist joint they will slide through smooth sheaths. The tendon sheaths are also known as tenosynovium. They allow the tendons to slide through smoothly in a low-friction method. The most common signs that you have wrist tendonitis is the tendon sheath or tenosynovium, becomes a lot more thicker than it usually is and constricts the tendons sliding movement. These are good signs to show whether you have wrist tendonitis. If the tendon of the wrist is inflamed, then the movement of the joint will become very sore and complicated to move. It can cause a lot of stress to the patient and would need to be checked out immediately to find the best method to cure the pain. Many people try to take a medication which can be a good idea if you are suffering from a large amount of pain, and want this pain to go away , pain pills were made for just such the occasion so if you are in a large amount of pain take a pain pill, then if you think this pain is going to progress go see your doctor as soon as you can because the strength of pain pills can wear off. Then you could still be stuck with all of the pain you were having, in a situation like this it is always best to get to your normal doctor’s office as soon as possible.