NEWS FDA Safety Labeling Changes: Humira

[Guest guest]

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