TUESDAY, Aug. 4 (HealthDay News) -- Drugs widely used to fight rheumatoid arthritis, Crohn's disease and other inflammatory disorders must now carry an updated "black box" warning label cautioning patients and doctors that the medicines may boost cancer risk in children and adolescents, the U.S. Food and Drug Administration announced Tuesday.

The drugs, called tumor necrosis factor (TNF) blockers, work by interrupting a protein that causes inflammation and damage to bones, cartilage and other tissue. They include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).

"FDA announced that it has completed its analysis of TNF blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents," according to FDA spokeswomen Crystal Rice.

"This new safety information is now being added to the boxed warning for these products," she said.

TNF blockers already carry FDA-mandated warning labels for other potential safety issues, including fungal infections. Tuesday's announcement follows on the agency's move last year to review several dozen reports of children who developed cancer while taking the medications. That investigation started in June 2008. The analysis took into account a number of reports of cancers in children treated with these drugs. The malignancies tended to arise about 30 months after starting on the medications.

About half of the cancers were lymphomas and some of the children died, according to the FDA.

The issue gained more prominence in July 2008 when doctors reporting in the New England Journal of Medicine outlined the case of a woman with Crohn's disease who took a TNF blocker and then developed lung cancer. When she ceased using the drug, her cancer disappeared.

The agency is working with manufacturers to find new ways to define the risk of cancer in children and adolescents who use these drugs.

Dr. Patience White, chief public health officer at the Arthritis Foundation, said the risks and benefits of these drugs need to be weighed and the final decision whether to take them or not must be an individual one.

However, "it's good to have this information out there," White said. "It gives people with arthritis an opportunity to go to their doctor and talk about the risk/benefits."

People with these inflammatory illnesses are already at an increased risk for cancer, White noted.

"Then you are giving a drug that probably increases the risk as well. But are both of those worth not taking the drug, and being disabled? That's the discussion," she said.

The hard part for patients will be to balance these risks and benefits, White added. "The risks of the side effects are often very small, but the chance that a person with juvenile arthritis will be disabled and deformed is very high if they don't take therapy," she said. "People often focus on risks and forget the benefits."

Deciding whether or not to take these drugs should be based on the type of disease and a family history of cancer, White said. "It really matters to have a discussion about this," she said. "There isn't really one risk/benefit profile that fits for everybody."

According to the FDA's Rice, patients taking these drugs should:

• Be aware that taking TNF blockers may increase the risk of developing lymphoma, leukemia, and other cancers.
• Be aware that taking TNF blockers may increase the risk of developing psoriasis and may worsen pre-existing psoriasis.
• Review the accompanying medication guide.
• Do not stop or change medicines that have been prescribed without first talking with a knowledgeable health care professional.
• Pay close attention for any signs or symptoms of cancer such as unexplained weight loss or fatigue, swollen lymph nodes in the neck, underarms or groin, or easy bruising or bleeding. Promptly discuss any signs and symptoms with a health care professional.

More information

For more information on TNF blockers and cancer risk, visit the FDA.

THURSDAY, July 30 (HealthDay News) -- Levels of a certain protein strongly predict the risk of hip and knee joint replacement as a result of severe osteoarthritis, a new study shows.

The research involved 912 healthy people in Italy, including 60 who had severe osteoarthritis that led to a knee or hip replacement between 1990 and 2005. Those with high levels of vascular cell adhesion molecule 1 (VCAM-1) at the start of the study were most likely to undergo joint replacement, the study found. VCAM-1 is expressed on cells in the cartilage and connective tissue.

"The level of VCAM-1 emerged as a significant predictor of the risk of joint replacement due to severe OA, equaling or even surpassing the effects of age," wrote Georg Schett, of the University of Erlangen-Nuremburg in Germany, and his colleagues.

They also found that including VCAM-1 levels in risk prediction models led to more accurate classification of patients.

The study, which appears in the August issue of Arthritis & Rheumatism, is the first to establish a laboratory biomarker for the risk of severe osteoarthritis, according to background information in a news release from the journal. Such biomarkers can lead to early diagnosis of the disease, before clinical symptoms appear. Improved prediction of severe osteoarthritis, experts say, could help identify people who would benefit from interventions such as weight loss, strength training and aerobic exercise.

The researchers said that learning more about the underlying mechanism in the link between VCAM-1 and osteoarthritis might also help improve understanding about the causes of the joint disease.

More information

The Arthritis Foundation has more about osteoarthritis  .

TUESDAY, July 7 (HealthDay News) -- Minimally invasive surgery for the excruciating back pain that can be caused by sciatica didn't work as well as the conventional procedure in a Dutch study.

"The expected treatment benefit of a faster rate of recovery from sciatica after tubular diskectomy could not be reproduced by this double-blind study," according to a report in the July 8 issue of the Journal of the American Medical Association.

Orthopedic surgeons at the Medical Center Haaglanden studied 328 people who underwent surgery for sciatic pain, and found that "the overall differences in pain intensity and recovery rates favored the conventional microdiskectomy."

Surgery is done to remove the portion of a disk that has ruptured and causes pain by pressing on the sciatic nerve. The older method, microdiskectomy, is done through a larger incision than that used for transmuscular tubular diskectomy, the minimally invasive technique that was introduced in 1997 and has gained wide popularity. But only a few studies comparing results of the two techniques have been reported.

"The reason why it [minimally invasive surgery] did not work could be because our conventional technique uses a small incision as well," said study author Dr. Mark P. Arts.

Minimally invasive surgery might still be recommended in some cases, Arts noted. "We are still working on our subgroup analysis, but possibly the tubular diskectomy is indicated in obese patients in whom a large incision and exposure is inevitable," he said.

But more patients probably will prefer the conventional approach, Arts said. "We will discuss the results of our study with our patients and their prejudiced opinion of small being better will probably change into, 'Do what's best for me,'" he said.

The results of the Dutch study were no surprise to Dr. Todd J. Albert, director of the department of orthopedic surgery at the Rothman Institute of Thomas Jefferson University in Philadelphia.

"We have people in our unit who did a similar study and found very similar results," Albert said. That study has been submitted to a medical journal for publication, he noted.

Any minimally invasive surgical technique is bound to be popular "because the public wants a less invasive procedure if it accomplishes the same thing," Albert said. "Sometimes it pans out and sometimes it doesn't. With knee surgery it has, but minimally invasive hip surgery, which was a big rage a few years ago, is not necessarily better."

In his practice, Albert said, surgery for sciatic pain is done with a procedure halfway between the conventional and minimally invasive methods. "Maybe my incision is a half a centimeter longer than for microdiskectomy," he said. "We find the window where the disk is pressing on the nerve and push it out. It is much more like the open-surgery approach."

In practical terms, the real question about surgery for sciatica is not which technique should be used but whether surgery should be done, said Dr. Michael Y. Wang, an associate professor of neurological surgery and rehabilitation medicine at the University of Miami Miller School of Medicine.

"In general, the answer is, when you have a neurological deficit or intractable pain or a problem threatening loss in terms of neurological function," Wang said. The most common reason is to ease pain, he said.

The differences shown in the Dutch study are not great enough to say that one procedure is clearly preferable over the other, Wang noted. "I use the conventional technique even though I'm a minimally invasive surgeon," he said. "For sciatica, the minimally invasive method is too complicated and involved."

The Dutch results are not directly transferable to the United States for several reasons, Wang said. For example, those who had surgery in the study stayed an average of 3.3 days in the hospital. Such a long stay is virtually unheard of in the United States, where hospital discharge is almost always done a day or two after surgery, Wang said.

More information

Sciatica and its treatment are described by the U.S. National Library of Medicine.