NEWS - FDA updates warnings for TNF blockers and cancer risk

[Guest guest]

FDA Updates Warnings for TNF Blockers and Cancer Risk

Emma Hitt

Published: 08/04/2009

August 4, 2009 — The US Food and Drug Administration (FDA) is

requiring stronger warnings regarding the risk for cancer associated

with tumor necrosis factor (TNF) blockers.

An alert sent today from MedWatch, the FDA's safety information and

adverse event reporting program, states that the warnings will include

an updated boxed warning and highlight the increased risk for cancer

in children and adolescents who take TNF blockers for the treatment of

juvenile rheumatoid arthritis, Crohn's disease, and other inflammatory

diseases.

Today's action represents the completion of an investigation announced

by the FDA in June 2008. On average, an increased risk for cancer was

reported after 30 months of treatment with TNF blockers. Lymphoma was

the most common cancer type, accounting for about half of all cancers.

" The current prescribing information for TNF blockers does contain a

warning for malignancies, but does not specifically mention leukemia, "

the FDA states.

In addition to the updated boxed warning, the FDA is requiring an

update to the Warning section of the prescribing information

describing reported cases of leukemia in adults, adolescents, and

children, as well as additional information on malignancies in

children and adolescents. Psoriasis is also associated with the use of

TNF blockers, and this information will be incorporated into updated

prescribing information in the Adverse Events section. The revised

medication guide given to patients will include this new safety

information.

The TNF blockers include infliximab (Remicade, Centocor Ortho Biotech

Inc), etanercept (Enbrel, Amgen and Wyeth), adalimumab (Humira,

Abbott), certolizumab pegol (Cimzia, UCB), and golimumab (Simponi,

Centocor Ortho Biotech Inc and Schering-Plough Corporation).

More information is available on the MedWatch Web site.

Adverse events related to use of TNF blockers should be communicated

to the FDA's MedWatch reporting program by telephone at

1-800-FDA-1088, by fax at 1-800-FDA-0178, online at

http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane,

Rockville, land 20852-9787.

http://www.medscape.com/viewarticle/706973

Not an MD

[Guest guest]

Does anyone know if Orencia should be on this list? Is Orencia a " TNF blocker " ?

Thanks.

> From: <Rheumatoid.Arthritis.Support@...>

> Subject: [ ] NEWS - FDA updates warnings for TNF blockers and cancer

risk

> " " < >

> Date: Thursday, August 6, 2009, 6:57 PM

> FDA Updates Warnings for TNF Blockers

> and Cancer Risk

>

>

> Emma Hitt

> Published: 08/04/2009

>

>

> August 4, 2009 — The US Food and Drug Administration

> (FDA) is

> requiring stronger warnings regarding the risk for cancer

> associated

> with tumor necrosis factor (TNF) blockers.

>

> An alert sent today from MedWatch, the FDA's safety

> information and

> adverse event reporting program, states that the warnings

> will include

> an updated boxed warning and highlight the increased risk

> for cancer

> in children and adolescents who take TNF blockers for the

> treatment of

> juvenile rheumatoid arthritis, Crohn's disease, and other

> inflammatory

> diseases.

>

> Today's action represents the completion of an

> investigation announced

> by the FDA in June 2008. On average, an increased risk for

> cancer was

> reported after 30 months of treatment with TNF blockers.

> Lymphoma was

> the most common cancer type, accounting for about half of

> all cancers.

>

> " The current prescribing information for TNF blockers does

> contain a

> warning for malignancies, but does not specifically mention

> leukemia, "

> the FDA states.

>

> In addition to the updated boxed warning, the FDA is

> requiring an

> update to the Warning section of the prescribing

> information

> describing reported cases of leukemia in adults,

> adolescents, and

> children, as well as additional information on malignancies

> in

> children and adolescents. Psoriasis is also associated with

> the use of

> TNF blockers, and this information will be incorporated

> into updated

> prescribing information in the Adverse Events section. The

> revised

> medication guide given to patients will include this new

> safety

> information.

>

> The TNF blockers include infliximab (Remicade, Centocor

> Ortho Biotech

> Inc), etanercept (Enbrel, Amgen and Wyeth), adalimumab

> (Humira,

> Abbott), certolizumab pegol (Cimzia, UCB), and golimumab

> (Simponi,

> Centocor Ortho Biotech Inc and Schering-Plough

> Corporation).

>

> More information is available on the MedWatch Web site.

>

> Adverse events related to use of TNF blockers should be

> communicated

> to the FDA's MedWatch reporting program by telephone at

> 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at

> http://www.fda.gov/medwatch, or by mail to 5600 Fishers

> Lane,

> Rockville, land 20852-9787.

>

>

> http://www.medscape.com/viewarticle/706973

>

>

>

> Not an MD

>

>

> ------------------------------------

>

>

[Guest guest]

Orencia is a selective t-cell costimulator, not a TNF inhibitor. It does,

however, carry a similar risk of malignancies.

Kate P-B in St. Louis

Sent from my Verizon Wireless BlackBerry

[Guest guest]

Correction, Orencia is a selective t-cell costimulation MODULATOR. Whatever

that means!

Kate P-B

Sent from my Verizon Wireless BlackBerry

Re: [ ] NEWS - FDA updates warnings for TNF blockers and

cancer risk

Orencia is a selective t-cell costimulator, not a TNF inhibitor. It does,

however, carry a similar risk of malignancies.

Kate P-B in St. Louis

Sent from my Verizon Wireless BlackBerry

[Guest guest]

Kate,

Thank you for the info.

> From: microminimalist@... <microminimalist@...>

> Subject: Re: [ ] NEWS - FDA updates warnings for TNF blockers and

cancer risk

>

> Date: Friday, August 7, 2009, 7:43 AM

> Correction, Orencia is a selective

> t-cell costimulation MODULATOR.  Whatever that

> means! 

>

> Kate P-B

> Sent from my Verizon Wireless BlackBerry

>

> Re: [ ] NEWS - FDA updates warnings for

> TNF blockers and cancer risk

>

>

> Orencia is a selective t-cell costimulator, not a TNF

> inhibitor.  It does, however, carry a similar risk of

> malignancies.

>

> Kate P-B in St. Louis

> Sent from my Verizon Wireless BlackBerry

>

>

>

> ------------------------------------

>

>

[Guest guest]

Kate,

Orencia (abatacept) interferes with T-cell activation. In order for

T-cells to become fully activated, they must receive two signals.

Orencia blocks one of them - the one that would be received through a

costimulatory receptor.

The idea is that Orencia interrupts the chain of events which is

thought to lead to inflammation.

Orencia targets an earlier part of the process than the TNF blockers do.

Not an MD

On Fri, Aug 7, 2009 at 7:43 AM, <microminimalist@...> wrote:

> Correction, Orencia is a selective t-cell costimulation MODULATOR.  Whatever

that means!  

>

> Kate P-B