NEWS - Black box warning issued for Enbrel regarding infections

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Black Box Warning Issued for Etanercept Regarding Infections

March 18, 2008 — A black box warning has been issued for etanercept

(Enbrel, manufactured by Immunex Corporation; marketed by Amgen and

Wyeth Pharmaceuticals) regarding the risk for tuberculosis and other

infections, according to a news release distributed March 17 by Amgen

and Wyeth Pharmaceuticals. Etanercept is a fully human soluble tumor

necrosis factor (TNF) receptor antagonist that was first approved by

the US Food and Drug Administration (FDA) in 1998 for moderate to

severe rheumatoid arthritis.

Whereas the prescribing information had previously included a

bold-face warning regarding the risk of infections and tuberculosis,

this information is now designated as a black box warning, according

to an alert sent from MedWatch, the FDA's safety information and

adverse event reporting program. The new warning also highlights

screening and monitoring patients for tuberculosis, including patients

who tested negative for latent tuberculosis infection.

" In addition, the boxed warning states that tuberculosis has been

observed in patients receiving TNF-blocking agents, including ENBREL,

and that tuberculosis may be due to reactivation of latent

tuberculosis infection or to new infection, " the news release states.

" The boxed warning notes that data from clinical trials and

preclinical studies suggest that the risk of reactivation of latent

tuberculosis infection is lower with ENBREL than with TNF-blocking

monoclonal antibodies. The boxed warning further notes that,

nonetheless, post-marketing cases of tuberculosis reactivation have

been reported for TNF blockers, including ENBREL. "

Both Amgen and Wyeth will maintain an ongoing pharmacovigilance

program including postmarketing surveillance and analysis and

evaluation of all safety reports from clinical and open-label trials.

Clinical studies enrolling more than 20,000 patients worldwide have

shown cases of tuberculosis in approximately 0.01% of patients treated

with Enbrel. In trials enrolling more than 15,000 patients in the

United States and Canada, about 0.007% of those patients treated with

Enbrel developed tuberculosis.

The adverse reaction information for etanercept was also updated to

reflect new data from postmarketing surveillance reports, and

additional information was added to the immunogenicity section

regarding antibody assays.

The US indication for juvenile idiopathic arthritis (JIA) also was

updated. The new indication is to reduce the signs and symptoms of

moderately to severely active polyarticular JIA in patients 2 years of

age and older.

Patients will receive a new Medication Guide when a prescription for

Enbrel is dispensed in the United States, and healthcare professionals

will receive a " Dear Healthcare Professional " letter about the

updates, which will also be posted online at http://www.enbrel.com.

http://www.medscape.com/viewarticle/571628

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Not an MD