TUESDAY, July 8 (HealthDay News) -- Antibiotics known as fluoroquinolones will need to carry a black box warning alerting physicians to the increased risk of tendonitis and tendon rupture associated with their use, the U.S. Food and Drug Administration said Tuesday.

This risk is greatest among people over 60; in kidney, heart and lung transplant recipients; and among those taking steroids, the agency said.

The FDA is also asking doctors to advise their patients that if they have any sign of tendon pain and swelling or inflammation, they should stop taking the drugs immediately. Patients also should avoid exercising the affected area and contact their doctor immediately.

Tendon rupture can occur during or after taking fluoroquinolones, which include Cipro. Cases of tendon rupture have been reported up to several months after completing fluoroquinolone therapy, according to the FDA.

The drugs affected by the warning include: 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); and ofloxacin (marketed as Floxin and generic ofloxacin).

The FDA is also notifying makers of fluoroquinolones that they need to develop and distribute a medication guide for patients, alerting them to the possible side effects.

"All the currently marketed fluoroquinolones contain warnings regarding the risk of tendon-related adverse events, including the risk of tendon rupture," Dr. Edward Cox, director of the Office of Antimicrobial Products at the FDA's Center for Drug Evaluation and Research, said during an afternoon teleconference. "The new language will strengthen the existing warnings."

"Despite the current warning information on tendon adverse events and tendon rupture, the FDA continues to receive a considerable number of reports of tendon-related adverse events," Cox said. "The FDA believes the new labeling changes will better inform health-care providers and patients about the risk of tendon rupture."

Makers of fluoroquinolones are required to submit the changes to the label to the FDA within 30 days, Cox said.

Dr. Renata Albrecht, director of the Division of Special Pathogen and Transplant Products at FDA's Center for Drug Evaluation and Research, said the ruptures "occur most frequently in the Achilles' tendon."

Achilles' ruptures associated with fluoroquinolones are three to four times more frequent than ruptures among people not taking these drugs, Albrecht said. In the general population, the rate of tendon ruptures is about one in 100,000, she noted.

Signs and symptoms of tendon rupture can include a snap or pop in a tendon area, bruising after an injury in a tendon area, inability to move the affected area or bear weight, the agency said.

The FDA said pain, swelling, inflammation, and tears of tendons -- including the Achilles, shoulder, hand, or other tendons -- can happen in patients taking fluoroquinolone antibiotics. Tendons are the areas that connect muscles to joints.

Prior to requesting the black box warning, the FDA had been sued by the consumer group Public Citizen for ignoring "long-standing evidence" that fluoroquinolones can cause tendon ruptures. The consumer group had been calling upon the agency to add such a warning since 2006.

In January, Public Citizen said that from November 1997 through December 2005, the FDA had received 262 reports of tendon ruptures among fluoroquinolone users. Most involved ruptures of the Achilles' tendon. The group also cited hundreds of additional cases of tendonitis and other tendon disorders.

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

After Tuesday's announcement, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said the black box warning accomplishes two of the three steps that Public Citizen has urged the FDA to take for nearly two years.

But, he added in a news release, "The FDA is silent on our request that it also send a warning letter to physicians clearly describing possible adverse reactions, such as tendon pain, so that patients can be switched to alternative treatments before tendons rupture."

More information

For more on antibiotics, visit the U.S. National Library of Medicine.

FRIDAY, June 27 (HealthDay News) -- Total hip replacements are beneficial and economical for seniors with osteoarthritis, regardless of their age, say researchers at Duke University Medical Center.

Their study, published in the June issue of the Journal of the American Geriatrics Society, found those who had the surgery were twice as likely as those who didn't to gain mobility and the ability to take care of one's self.

"We found that total hip arthroplasty improves everyday life for patients and is as beneficial to people in their 80s or 90s as it is for someone in their 60s," Linda George, associate director of the Duke Center for the Study of Aging, said in a prepared statement. "While the number of surgeries conducted in the U.S. has increased dramatically over the last decade, fewer than 25 percent of patients who could benefit from the procedure elect to receive it."

Also, the surgery saves the health-care system, because the average $4,000 to $6,000 reimbursement for the procedure costs far less than the long-term expenses of health care for the disabled. Health economists estimate a $50,000 a year savings associated with a disability-free life.

The study is based on data from 131 patients who received total hip replacement compared to data from 257 patients who did not even know they had osteoarthritis. The patients were interviewed three times each year for four years.

Osteoarthritis of the hip is a progressive type of arthritis that affects about 10 million Americans. Associated with aging and obesity, it causes pain, decreased mobility and increased risk of falls and fractures. Hip replacements are performed when medications and physical therapy fail.

As total hip replacement is an invasive treatment with a long rehabilitation period, some physicians don't like to offer the option to patients older than 85, George said, and that is also why some older patients are reluctant to choose it when it is presented.

More information

The Arthritis Foundation has more about osteoarthritis  .

THURSDAY, June 26 (HealthDay News) -- New recommendations for the use of disease-modifying anti-rheumatic drugs (DMARDs) in the treatment of rheumatoid arthritis (RA) have been developed by the American College of Rheumatology.

The recommendations on the use of non-biologic and biologic DMARDs in RA address five key areas: indications for use; monitoring for side effects; assessing clinical response; screening for tuberculosis (a risk factor associated with biologic DMARDs); and under certain circumstances (i.e. high disease activity) the roles of cost and patient preference in choosing biologic agents.

The recommendations, published in the June issue of the journal Arthritis Care & Research, also take into account RA disease duration, disease severity, and prognostic features.

"These recommendations were developed for specialist clinicians familiar with assessing RA disease activity and disease severity," project co-leader Dr. Kenneth Saag, professor of medicine and epidemiology at the University of Alabama at Birmingham, said in a prepared statement.

"Applying these recommendations to clinical practice requires individualized patient assessment and clinical decision-making. The recommendations developed are not intended to be used in a 'cookbook' or prescriptive manner or to limit a physician's clinical judgment, but rather to provide guidance based on clinical evidence and expert panel input," Saag said.

The recommendations include:

• Methotrexate or leflunomide therapy is recommended for most RA patients.
• Methotrexate plus hydroxychloroquine is endorsed for patients with moderate to high disease activity.
• The triple DMARD combination of methotrexate plus hydroxychloroquine plus sulfasalazine for patients with poor prognostic features and moderate to high levels of disease activity.
• Prescribing anti-TNF agents -- etanercept, infliximab, or adalimumab -- along with methotrexate in early RA (less than 3 months) only for patients with high disease activity who had never received DMARDs. In intermediate- and longer-duration RA, anti-TNF agents are recommended for patients who had failed to respond adequately to methotrexate therapy.
• Reserving the fusion protein abatacept and the B-cell antibody rituximab for patients with at least moderate disease activity and poor disease prognosis for whom methotrexate in combination with or sequential administration of other nonbiologic DMARDs led to an inadequate response.
• Avoiding the initiation or resumption of treatment with methotrexate, leflunomide, or biologic agents for patients with active bacterial infection, active herpes-zoster viral infection, active or latent tuberculosis, or acute or chronic hepatitis B or C.
• Not prescribing anti-TNF agents to patients with a history of heart failure, with a history of lymphoma, or with multiple sclerosis or demyelinating disorders.
• Avoiding the initiation or resumption of methotrexate, leflunomide, or minocycline for RA patients planning for pregnancy and throughout the duration of pregnancy and breastfeeding.

"These recommendations are extensive but not comprehensive, and it is intended that they will be regularly updated to reflect the rapidly growing scientific evidence in this area along with changing practice patterns in rheumatology," Saag said.

More information

The Arthritis Foundation has more about arthritis treatments  .