Navigation Links
Certain Arthritis, Crohn's Drugs May Raise Kids' Cancer Risk: FDA
Date:8/4/2009

Agency strengthens 'black box' warning on medicines such as Enbrel, Remicade

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.



SOURCES: Crystal Rice, spokeswoman, U.S. Food and Drug Administration; Patience White, M.D., chief public health officer, Arthritis Foundation; Aug. 4, 2009, statement, U.S. Food and Drug Administration


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Use of certain lipid measures not more effective in predicting coronary heart disease
2. Class Settlement Could Result in Considerable Savings for Certain Consumers of Prescription Pharmaceuticals
3. MU researchers studying model to learn why certain cancers become resistant to drugs
4. New All-Natural Dietary Supplement Made from Muscadine Grape Skins Helps Inhibit Growth of Certain Cancers
5. Effectiveness of most PTSD therapies is uncertain
6. Value of Most Post-Traumatic Stress Treatments Uncertain
7. Certain Seizure Patients Need Emergency CT Scan
8. Ipsen and Debiopharm Extend Their Agreement for the Exclusive Commercialization of Decapeptyl(R) (triptorelin pamoate) in Europe and Certain Other Territories
9. Certain Cholesterol Drugs Show Their Limits
10. ADHD Delays Growth of Certain Brain Areas
11. Stress hormone may hasten the progression of certain blood cancers
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Certain Arthritis, Crohn's Drugs May Raise Kids' Cancer Risk: FDA
(Date:5/25/2016)... ... May 25, 2016 , ... TransactRx announces the release of ... medical service claims by Pharmacy Benefit Managers that were submitted by Retail Clinics ... TransactRx Cross Benefit Clearinghouse receives standard professional medical claims submitted from the retail ...
(Date:5/25/2016)... FRANCISCO, CA (PRWEB) , ... May 25, 2016 , ... ... School of Nursing and Health Professions. She will lead a team of more than ... Team. Baker will begin her role as dean in late August. , Baker comes ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... Laser ... to help turn back the hands of time of female aging. The ... childbirth. Women with symptoms such as leakage, laxity, itchiness and pain have reported ...
(Date:5/25/2016)... NJ (PRWEB) , ... May 25, 2016 , ... Researchers ... 2016 Annual COVD Meeting for their work on visual evoked potential and human attention. ... recent studies that used the Diopsys® NOVA™ ERG and VEP Vision Testing System ...
(Date:5/25/2016)... ... May 25, 2016 , ... HealthPostures ... will join America's leading engineers at the American Society of Safety Engineers Conference ... Congress Center. , Engineers, speakers and exhibitors from more than 40 countries ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... 24, 2016 Niederländische Chirurgen ... die es Ärzten erlaubt, ihre Expertise weltweit zu ... kombiniert Live Streaming mit einer Instant-Messaging-Funktion und der ... Mediziner in Europa, Afrika, Asien und den ... die Plattform registriert. Information und Weiterbildung   ...
(Date:5/24/2016)... 2016  Diana Russell suffers from a form of ... inside out.  This disease has put her in a ... and grandchildren to leave her home.  Because of the ... haul the wheelchair.  So if there is a family ... is left to wait for the bus. ...
(Date:5/24/2016)... Marziani has joined VMS BioMarketing as senior vice president of sales, announced Andrea ... Marziani will lead the company,s business development and sales team, exploring new opportunities for ... - http://photos.prnewswire.com/prnh/20160523/371089 ... ... ...
Breaking Medicine Technology: