Re: NEWS FDA Safety Labeling Changes: Humira

[Guest guest]

Thanks a. I have my rheumy appt today and I printed this out to

bring with me.

> 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]

Thanks a. I have my rheumy appt today and I printed this out to

bring with me.

> 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