NEWS - FDA Safety Changes: Celebrex, Crixivan, Rifater

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FDA Safety Changes: Celebrex, Crixivan, Rifater

March 12, 2009 — The US Food and Drug Administration (FDA) has

approved safety labeling revisions to provide new information

regarding the increased risk for cardiovascular events in patients

receiving long-term celecoxib therapy, warn of drug interactions

between indinavir sulfate and statins, and advise of the need to

monitor liver function in certain patients receiving treatment with

rifampin as part of a tuberculosis regimen.

Long-Term Celecoxib (Celebrex) Use Linked to Increased Risk for

Cardiovascular Events

On December 31, 2008, the FDA approved safety labeling revisions for

celecoxib capsules (Celebrex; Pfizer, Inc) to include new study data

regarding the risk for cardiovascular (CV) thrombotic adverse events

in patients receiving long-term treatment with nonsteroidal

anti-inflammatory drugs (NSAIDS).

The warning was based on results of the Adenoma Prevention with

Celecoxib trial in 2035 patients, showing that use of 400 mg of

celecoxib twice daily was linked to a 3.4-fold increase in the

composite risk for CV death, myocardial infarction (MI), and stroke,

relative to placebo (95% confidence interval [CI], 1.4 - 8.5). In

patients receiving 200 mg of celecoxib twice daily, the hazard ratio

was 2.8 (95% CI, 1.0 - 6.4).

Cumulative rates for this composite endpoint during 3 years were 3.0%

(20/671 subjects) and 2.5% (17/685 subjects), respectively, vs 0.9%

(6/679 subjects) with placebo treatment; dose-related increases in

both treatment groups were driven by a substantial increase in the

rate of MI.

Clinical trials of up to 3 years' duration have supported these

findings, linking several cyclooxgenase 2 (COX-2) selective and

nonselective NSAIDs to an increased risk for serious and potentially

fatal CV thrombotic events, MI, and stroke. According to the FDA, all

NSAIDs may have similar risks that increase with dose, duration of

use, and the presence of existing CV disease and/or related risk

factors.

Clinicians are advised to remain alert for the development of CV

events, even in the absence of previous symptoms. The FDA notes that

there is no consistent evidence that concurrent use of low-dose

aspirin mitigates the risk for thrombotic events, and concomitant use

of both drugs does increase the risk for serious gastrointestinal

tract adverse events.

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Read the full article here:

http://www.medscape.com/viewarticle/589558

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