Re: NEWS FDA Safety Labeling Changes: Humira (My Rheumy)

[Guest guest]

Had my rheumy appt today. I showed him the article below and he

stated (as we have all seen in research posted to this group) that

the risk of getting lymphoma is greater for untreated RA than if you

are on a TNF blocker. I wonder if a bigger study would show this?

I hope the change to the warning label does not scare people away

from Humira.

Humira has made more difference in my RA treatment than anything else

has. I am going down to 1mg of prednisone (from 2mgs daily) and at

my next appt in December I might get off! I am also decreasing my

dose of mtx from 17.5mgs to 15mgs in hopes that it helps the hair

loss I've been experiencing. I feel the Humira is allowing me to

reduce the drugs that have given me the side effects. The worst side

effect I've had from Humira is a little swelling and rash at the

injection site. Not a big thing at all.

Jennie

> Adalimumab (Humira) Associated With Risk of Malignancy, Other

Adverse Events

>

> On July 18, the FDA approved revisions to the safety labeling for

adalimumab

> (Humira, made by Abbot) to warn of the risk of malignancy,

hypersensitivity

> reactions, and hematologic adverse events that may be associated

with its

> use.

>

> During a controlled-trial period of seven months, two lymphomas were

> observed among 1,380 adalimumab-treated patients with moderately to

severely

> active rheumatoid arthritis (RA) compared with 0 malignancies among

> placebo-treated patients. In controlled and open-label studies, 10

lymphomas

> were observed in 2,468 patients over 4,870 patient-years of

adalimumab

> therapy.

>

> The FDA has also received rare postmarketing reports of anaphylaxis

after

> adalimumab administration. Clinical trials have shown a 1% overall

incidence

> rate of allergic reactions, including allergic rash, anaphylactoid

reaction,

> fixed drug reaction, nonspecified drug reaction, and urticaria.

>

> Tumor necrosis factor-¦Á inhibitors such as adalimumab have been

associated

> with rare reports of pancytopenia, including aplastic anemia.

Adalimumab use

> has resulted in infrequent reports of hematologic adverse events,

including

> medically significant cytopenia.

>

> Adalimumab is indicated for reducing the signs and symptoms of RA,

for

> inhibiting the progression of structural damage in RA, and for

improving

> physical function in adult patients with moderately to severely

active RA

> who have had inadequate response to one or more disease-modifying

> antirheumatic drugs.

>

> http://www.medscape.com/viewarticle/489275_print

[Guest guest]

Had my rheumy appt today. I showed him the article below and he

stated (as we have all seen in research posted to this group) that

the risk of getting lymphoma is greater for untreated RA than if you

are on a TNF blocker. I wonder if a bigger study would show this?

I hope the change to the warning label does not scare people away

from Humira.

Humira has made more difference in my RA treatment than anything else

has. I am going down to 1mg of prednisone (from 2mgs daily) and at

my next appt in December I might get off! I am also decreasing my

dose of mtx from 17.5mgs to 15mgs in hopes that it helps the hair

loss I've been experiencing. I feel the Humira is allowing me to

reduce the drugs that have given me the side effects. The worst side

effect I've had from Humira is a little swelling and rash at the

injection site. Not a big thing at all.

Jennie

> Adalimumab (Humira) Associated With Risk of Malignancy, Other

Adverse Events

>

> On July 18, the FDA approved revisions to the safety labeling for

adalimumab

> (Humira, made by Abbot) to warn of the risk of malignancy,

hypersensitivity

> reactions, and hematologic adverse events that may be associated

with its

> use.

>

> During a controlled-trial period of seven months, two lymphomas were

> observed among 1,380 adalimumab-treated patients with moderately to

severely

> active rheumatoid arthritis (RA) compared with 0 malignancies among

> placebo-treated patients. In controlled and open-label studies, 10

lymphomas

> were observed in 2,468 patients over 4,870 patient-years of

adalimumab

> therapy.

>

> The FDA has also received rare postmarketing reports of anaphylaxis

after

> adalimumab administration. Clinical trials have shown a 1% overall

incidence

> rate of allergic reactions, including allergic rash, anaphylactoid

reaction,

> fixed drug reaction, nonspecified drug reaction, and urticaria.

>

> Tumor necrosis factor-¦Á inhibitors such as adalimumab have been

associated

> with rare reports of pancytopenia, including aplastic anemia.

Adalimumab use

> has resulted in infrequent reports of hematologic adverse events,

including

> medically significant cytopenia.

>

> Adalimumab is indicated for reducing the signs and symptoms of RA,

for

> inhibiting the progression of structural damage in RA, and for

improving

> physical function in adult patients with moderately to severely

active RA

> who have had inadequate response to one or more disease-modifying

> antirheumatic drugs.

>

> http://www.medscape.com/viewarticle/489275_print