Navigation Links
FDA Starts Safety Review of Autoimmune Disorder Drugs
Date:6/4/2008

Reports of increased cancer risk among young users of TNF blockers prompts action

WEDNESDAY, June 4 (HealthDay News) -- U.S. health officials have started a safety review of a class of drugs known as tumor necrosis factor (TNF) blockers, which are widely prescribed to treat autoimmune disorders such as rheumatoid arthritis, juvenile rheumatoid arthritis and Crohn's disease.

The announcement did not come as a surprise, as experts have long debated the risk-benefit profile of the drugs without coming to any consensus.

Among the chief concerns being investigated by the U.S. Food and Drug Administration are whether the drugs are associated with the development of cancer, especially lymphoma, in children and young adults being treated for rheumatoid arthritis or Crohn's disease. The agency is investigating about 30 reports of cancer in this younger age group submitted between 1998, after the approval of the first TNF blocker, through April of this year. TNF blockers have also been linked to an increased risk of infection.

"I think it's a fair thing to say this is an area of ongoing concern that has not been resolved. It's not something new," said Dr. Chaim Putterman, chief of the division of rheumatology at Montefiore Medical Center and Albert Einstein College of Medicine in New York City. "[The drugs] were approved in adults, and more drugs are coming out, and everyone would prefer an indication in children, so the FDA has decided to clear it. It has always been a concern, and it's something that should be clarified."

Four TNF blockers are currently approved in the United States: Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab) and Cimzia (certolizumab). Remicade is approved for use in children with Crohn's disease. Enbrel and Humira are approved to treat children with juvenile rheumatoid arthritis, according to the FDA.

The FDA review is focusing on the first three. All four are approved for multiple indications.

TNF blockers work by dampening the immune system, which becomes hyperactive in patients with rheumatoid arthritis.

The drugs have clear benefits, according to experts, and have revolutionized the treatment of some of these diseases.

"One of the reasons that these medications have such a market despite the concerns is that they are so remarkably effective," Putterman said. "There are not only subjective benefits but a tremendous amount of objective evidence, not only in inflammation and patient symptoms, but also in disease progression. These drugs have really addressed a previously unmet need."

"These drugs are probably the most important advance in the treatment of rheumatoid disorders in the last 20 to 30 years. They dramatically improve certain forms of crippling arthritis and almost stop them. Some people go from being in a wheelchair [to] jumping up and walking around," said Dr. Stephen Lindsey, head of rheumatology at Ochsner Health Service in Baton Rouge, La. "They're being used earlier and earlier, because they're so good. I think the FDA is being cautious. I think it's smart. What are the risks of a child being crippled and non-functioning versus the risk of cancer? Maybe, in odd cases, we need to think more and not jump in with all four limbs."

The increased risk for cancer may also be a result of factors other than the drug. "The signal [for cancer] has not been a dramatic one," Putterman said. "There are confounding factors in rheumatoid arthritis patients, which can make interpretation of the data more difficult."

One confounding factor is that rheumatoid arthritis patients, independent of treatment, have a higher risk of some cancers, and some patients have also been treated with methotrexate, a chemotherapy agent that has a known association with lymphoma.

And then there's the conflicting scientific evidence. One 2006 study reported that concerns about TNF blockers causing cancer were unfounded. But earlier this year, a review of the research concluded the risk may be real.

"TNF plays an important role in immune surveillance and, by blocking it, you might be interfering with the body's own defenses," Putterman said.

The FDA has requested that makers of TNF blockers approved for use in children and young adults supply information about all reported cases of cancer in children and young adults taking the drugs.

The maker of Cimzia, UCB Inc., must conduct a study looking at the long-term risks of this drug. That study will begin in 2009, and will take about a decade to complete.

In the meantime, the FDA has asked health-care professionals to weigh the possible risks against the benefits when prescribing TNF blockers.

More information

Read about TNF blockers U.S. Food and Drug Administration.



SOURCES: Chaim Putterman, M.D., chief, division of rheumatology, Montefiore Medical Center and Albert Einstein College of Medicine, New York City; Stephen Lindsey, head, rheumatology, Ochsner Health Service, Baton Rouge, La.; June 4, 2008, U.S. Food and Drug Administration statement


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Haemacure Achieves Major Milestone - Starts Processing Plasma in Its New Fractionation Facility
2. Heart Disease Starts Early in Life
3. Mike Turner, Virginia Congressional Candidate, Starts Healthcare Countdown
4. Alzheimers Starts Earlier for Heavy Drinkers, Smokers
5. Gerresheimer Starts the Year Successfully in 2008
6. Kronos Optimal Health Company Aims to Stop Diabetes Before It Starts
7. April is National Child Abuse Prevention Month: Learn 24 Ways to Prevent Child Abuse ... Before it Starts
8. Healing Starts With Us National Campaign Commits to Battling Depression - By Any Means Necessary
9. The Gender Divide Starts Over Dinner
10. The Stay Strong Foundation Launches National Healing Starts With US Campaign With Celebrity Guests Denzel Washington, Ruby Dee, MoNique, Terry McMillan, Rev. Al Sharpton and Others
11. Taking Care of Your Skin Starts From Within
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Starts Safety Review of Autoimmune Disorder Drugs
(Date:5/24/2017)... , ... May 24, 2017 , ... Patients who want ... OH, can now meet with Dr. Joseph Bedich for a consultation, with or without ... improving their oral health and functionality. , Dr. Bedich offers a variety ...
(Date:5/24/2017)... , ... May 24, 2017 ... ... the female reproductive tract in which the endometrial lining of the uterus ... inflammation and pain. Patients experiencing painful intercourse, painful periods, pelvic pain, or ...
(Date:5/24/2017)... (PRWEB) , ... May 24, 2017 , ... ... practice is offering holistic pediatric dentistry options for its patients on Long Island, ... the patient’s entire physical well being, and is one of the biggest trends ...
(Date:5/24/2017)... Orange, NJ (PRWEB) , ... May 24, 2017 , ... ... for avoiding back injury when either lifting weights for strength training and exercise or ... Atlantic Spine Center . , “Body position is everything,” Dr. Chang says. “Improper technique ...
(Date:5/23/2017)... ... ... Allegheny Health Network and the Alexis Joy D’Achille Foundation ... at West Penn Hospital , a unique facility that will offer the most ... Construction of the Center is underway with a scheduled opening in the fall of ...
Breaking Medicine News(10 mins):
(Date:5/22/2017)... MAITLAND, Fla. , May 22, 2017 /PRNewswire/ ... industry as a whole continue to make the ... evidence becomes increasingly important for ensuring positive patient ... Key industry stakeholders are shifting focus away from ... results and effects of long-term specialty drug therapy ...
(Date:5/15/2017)... Enterin Inc., a privately-held CNS pharmaceutical company based ... to treat Parkinson,s disease (PD), has enrolled the first patient ... randomized, controlled, multicenter study involving patients with PD and taking ... over a 9-to-12-month period. The first stage is open label ... Participating sites include Denver , ...
(Date:5/10/2017)... -- Global Health Intelligence (GHI), the leading healthcare ... published its 2017 ranking of the Best-Equipped Hospitals in ... analysis from GHI,s hospitals database for Latin America , ... The GHI database covers 86% of the hospitals in ... points for each institution in key areas such as beds, ...
Breaking Medicine Technology: