fda warns of new infections with tnf blockers

FDA

FDA Warns of New Infections With TNF Blockers
By Nancy Walsh, Staff Writer, MedPage TodayPublished: September 07, 2011

The Food and Drug Administration has updated the boxed warning for all tumor necrosis factor-alpha (TNFa) inhibiting drugs to reflect the risk of infection from the bacteria Legionella and Listeria.

There now have been more than 100 cases of infection with these pathogens, according to the agency.

The TNFa inhibitors licensed in the United States are infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia), and golimumab (Simponi).
The drugs are used to treat rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and juvenile idiopathic arthritis.
Serious infections involving viral, bacterial, and mycobacterial pathogens are a recognized risk of treatment with these and other immunosuppressive drugs.

A total of 80 cases of Legionella pneumonia have been reported to the FDA among patients receiving TNFa inhibitors, most often for rheumatoid arthritis.
Median age of affected patients was 56.

Median duration of TNFa inhibitor treatment was 10.4 months, but cases occurred as early as within one month and as late as 73 months after beginning treatment.
Many of the patients were also being treated with methotrexate and corticosteroids, and 14 deaths occurred.

Thus far there also have been 23 published cases of Legionella pneumonia in patients ages 26 to 71, with three deaths.

In four of these cases, the pneumonia was severe enough to warrant mechanical ventilation, and in five cases, intensive care treatment was needed.
One patient had a second episode of Legionella pneumonia after treatment with the TNFa inhibitor was restarted.

There are also now 26 published cases of serious infections -- meningitis, endophthalmitis, bacteremia, and sepsis -- with Listeria monocytogenes in patients receiving these drugs.
Seven patients died of the infection.
In addition, FDA cautioned that Listeria infections also occurred during clinical trials of the TNFa inhibitors.

The agency continues to advise healthcare professionals to consider the benefits and risks of these drugs before initiating therapy, particularly in patients who have had chronic or recurrent infections or underlying disorders associated with immunosuppression.

Heightened risk of infection also exists for patients who are older than 65.
Any adverse events in patients receiving TNFa inhibitors should be reported to the FDA MedWatch program, the agency statement note......PS.{this demonstrates how CRUCIAL the safeter ASPECT of any DRUG is, in my opinion it clearly Shows how Bloody Good is XTOLL because its Saftey Aspect is Tremendous and it works........